FDA device companies: B
480 companies. All companies.
- B&B Medical Assoc., Inc. (5 510(k)s)
- B&B Medical Technologies, Inc. (23 510(k)s)
- B. Braun Avitum AG (5 510(k)s, 1 PMA)
- B. Braun Instruments (13 510(k)s)
- B.Braun Medical, Inc. (150 510(k)s)
- B.Braun Melsungen AG (5 510(k)s)
- B. Braun of America, Inc. (19 510(k)s)
- B C Medical , Ltd. (8 510(k)s)
- B & F Medical Products, Inc. (18 510(k)s)
- B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. (5 510(k)s)
- B-K Medical A/S (7 510(k)s)
- B-K Medical Aps (11 510(k)s)
- B-One Ortho, Corp. (13 510(k)s)
- B.T.I. Biotechnology Institute, Sl. (15 510(k)s)
- BAAT Medical Products B.V. (5 510(k)s)
- Bacchus Vascular, Inc. (10 510(k)s)
- Baebies, Inc. (3 510(k)s, 1 De Novo)
- Bailey Mfg. Co. (11 510(k)s)
- Bain Medical Equipment (Guangzhou) Co., Ltd. (7 510(k)s)
- Baisheng Medical Co., Ltd. (5 510(k)s)
- Baker Instructions Corp. (10 510(k)s)
- Balance Ophthalmics, Inc. (1 510(k)s, 1 De Novo)
- Baldur Systems Corp. (6 510(k)s)
- Ballard Medical Products (26 510(k)s)
- Balt USA, LLC (19 510(k)s, 1 PMA)
- Baltimore Therapeutic Equipment Co. (7 510(k)s)
- Banyan Biomarkers, Inc. (1 De Novo)
- Barco N.V. (60 510(k)s)
- Barco NV Barcoview (14 510(k)s)
- Barco NV Display Systems (10 510(k)s)
- Barcoview (17 510(k)s)
- Barcoview, Medical Imaging Systems (5 510(k)s)
- Bard Access Systems, Inc. (22 510(k)s)
- Bard Peripheral Vascular, Inc. (39 510(k)s, 6 PMA)
- Bardy Diagnostics, Inc. (7 510(k)s)
- Barnes-Hind, Inc. (7 510(k)s)
- Barnev, Ltd. (2 510(k)s, 1 De Novo)
- Baronova, Inc. (3 510(k)s, 1 PMA)
- Barosense, Inc. (5 510(k)s)
- Barriermed Glove Co. (5 510(k)s)
- Barrx Medical, Incorporated (13 510(k)s)
- Bartels Immunodiagnostic Supplies, Inc. (35 510(k)s)
- Bartels Prognostics, Inc. (1 PMA)
- Basic Dental Implant Systems, Inc. (6 510(k)s)
- Basic Medical Technology, Inc. (8 510(k)s)
- Battle Creek Equipment Co. (7 510(k)s)
- Bauer, Cheng & Associates, Inc. (11 510(k)s)
- Baui Biotech Co., Ltd. (5 510(k)s)
- Baumer Ortopedia , Ltd. (5 510(k)s)
- Bausch and Lomb (3 510(k)s, 1 PMA)
- Bausch Health (1 PMA)
- Bausch Health Companies, Inc. (1 PMA)
- Bausch & Lomb, Inc. (102 510(k)s, 30 PMA)
- Bausch & Lomb, Incorporated (23 510(k)s, 1 PMA)
- Bausch + Lomb Ireland Limited (1 PMA)
- Bausch & Lomb Pharmaceutical, Inc. (6 510(k)s)
- Bausch & Lomb Surgical, Inc. (1 PMA)
- Baxa Corp. (8 510(k)s)
- Baxa Corp., Sub. of Cook Group, Inc. (16 510(k)s)
- Baxano, Inc. (10 510(k)s)
- Baxter Bio Science (1 PMA)
- Baxter Diagnostics, Inc. (72 510(k)s)
- Baxter Edwards (11 510(k)s)
- Baxter Healthcare Corp (568 510(k)s, 5 PMA, 1 De Novo)
- Bay Labs, Inc. (1 510(k)s, 1 De Novo)
- Bay X-Ray, Inc. (6 510(k)s)
- Bayer Corp. (96 510(k)s)
- Bayer Diagnostics Corp. (32 510(k)s)
- Bayer Healthcare, LLC (55 510(k)s, 3 PMA)
- Bayer Healthcare, Diagnostics Division (2 510(k)s, 1 PMA)
- Bayer Medical Care, Inc. (10 510(k)s)
- Bayer Pharma AG (1 PMA)
- Baylis Medical Co., Inc. (28 510(k)s)
- Baylis Medical Company, Inc. (25 510(k)s)
- Baylis Medical Technologies, Inc. (5 510(k)s)
- Bci, Inc. (13 510(k)s)
- Bci Intl., Inc. (20 510(k)s)
- Bd (15 510(k)s)
- Bd Becton Dickinson Vacutainer Systems Preanalytic (632 510(k)s, 2 PMA)
- Bd Biosciences (10 510(k)s)
- Bd Diagnostic Systems (6 510(k)s, 1 PMA)
- Bd Diagnostics (2 PMA)
- Beacon Laboratories, Inc. (18 510(k)s)
- Beam-Med, Ltd. (1 510(k)s, 1 PMA)
- Bear Medical Systems, Inc. (28 510(k)s)
- Beaver Visitec International, Inc. (1 PMA)
- Beckman (6 510(k)s)
- Beckman Coulter, Inc. (277 510(k)s, 5 PMA, 1 De Novo)
- Beckman Coulter Ireland, Inc. (7 510(k)s)
- Beckman-Diagnostic Systems Group (11 510(k)s)
- Beckman Instruments, Inc. (281 510(k)s)
- Becton, Dickinson & CO (196 510(k)s)
- Becton Dickinson Advanced Diagnostics (10 510(k)s)
- Becton, Dickinson and Co. (6 510(k)s)
- Becton, Dickinson and Company (135 510(k)s, 1 PMA)
- Becton, Dickinson and Company (BD) (5 510(k)s)
- Becton Dickinson Diagnostic Instrument Systems (13 510(k)s)
- Becton Dickinson Immunocytometry Systems (21 510(k)s)
- Becton Dickinson Infusion Therapy Systems, Inc. (36 510(k)s)
- Becton Dickinson Microbiology Systems (33 510(k)s)
- Becton Dickinson Vacutainer Systems (15 510(k)s)
- Becton Dickinson Vascular Access, Inc. (25 510(k)s)
- Bedfont Scientific, Ltd. (6 510(k)s)
- Beech Medical, Inc. (5 510(k)s)
- Bego U.S.A. (7 510(k)s)
- Behring Diagnostics, Inc. (145 510(k)s)
- Beiersdorf, Inc. (45 510(k)s)
- Beiersdorf-Jobt, Inc. (5 510(k)s)
- Beijing Adss Development Co., Ltd. (10 510(k)s)
- Beijing Biosis Healing Biolog Ical Technology Co., Ltd. (7 510(k)s)
- Beijing Choice Electronic Technology Co., Ltd. (14 510(k)s)
- Beijing Choice Electronic Technololgy Co., Ltd. (29 510(k)s)
- Beijing East Whale Imaging Technology Co., Ltd. (6 510(k)s)
- Beijing Honkon Technologies Co., Ltd. (5 510(k)s)
- Beijing Nubway S&T Co., Ltd. (6 510(k)s)
- Beijing Sano Laser S&T Development Co.,Ltd (6 510(k)s)
- Beijing Superlaser Technology Co., Ltd. (5 510(k)s)
- Beijing Zksk Technology Co., Ltd. (6 510(k)s)
- Bellco Srl (Now Part of Medtronic, Inc) (1 De Novo)
- Bellus Medical, LLC (1 De Novo)
- Belmont Equipment Corp. (12 510(k)s)
- Belmont Instrument Corp. (22 510(k)s)
- Belport Company, Inc., Gingi-Pak (11 510(k)s)
- Beltone Electronics Corp. (42 510(k)s)
- Belun Technology Company Limited (5 510(k)s)
- Bemis Health Care (12 510(k)s)
- Bemis Mfg. Co. (12 510(k)s)
- Benlan, Inc. (7 510(k)s)
- Bennett X-Ray Corp. (23 510(k)s)
- Benson Medical Instruments Co. (5 510(k)s)
- Bentley Laboratories, Inc. (55 510(k)s)
- Benvenue Medical, Inc. (8 510(k)s)
- Benz Research and Development Corp. (12 510(k)s)
- Berchtold Holding GmbH (16 510(k)s)
- Berkeley Advanced Biomaterials, Inc. (15 510(k)s)
- Berkeley Electric Wheelchair Co. (6 510(k)s)
- Berkeley Medevices (5 510(k)s)
- Berlin Heart, Inc. (1 PMA)
- Berman, Pcp & Consultants, Inc. (7 510(k)s)
- Bernafon, Inc. (16 510(k)s)
- Bernafon-Maico, Inc. (9 510(k)s)
- Berpu Medical Technology Co., Ltd. (9 510(k)s)
- Berwick Medical Products, Inc. (5 510(k)s)
- Besglove Medicare Sdn. Bhd. (22 510(k)s)
- Besmed Health Business Corp (11 510(k)s)
- Best Industries (9 510(k)s)
- Best Manufacturing Company (6 510(k)s)
- Best Medical International, Inc. (6 510(k)s)
- Best Nomos (5 510(k)s)
- Best Vascular, Inc. (1 PMA)
- Bestgen Biotech Corp. (6 510(k)s)
- Beta Bionics, Inc. (8 510(k)s)
- Better Care Plastic Technology Co., Ltd. (11 510(k)s)
- Better Therapeutics (1 De Novo)
- Better Water, Inc. (5 510(k)s)
- Beyond Air, Inc. (1 PMA)
- Bfi- Medical Waste Systems (6 510(k)s)
- Bhp Diagnostix, Inc. (25 510(k)s)
- Bib, Inc. (5 510(k)s)
- Bicon, Inc. (18 510(k)s)
- Bien-Air Surgery SA (5 510(k)s)
- Bimini Health Tech (1 PMA)
- Binax, Inc. (30 510(k)s)
- Bio-Analytics Laboratories, Inc. (19 510(k)s)
- Bio-Chem Laboratory Systems, Inc. (5 510(k)s)
- Bio Clinic Co. (14 510(k)s)
- Bio Compression Systems, Inc. (16 510(k)s)
- Bio D Corp. (11 510(k)s)
- Bio/Data Corp. (37 510(k)s)
- Bio-Detek, Inc. (17 510(k)s)
- Bio-Feedback Systems, Inc. (11 510(k)s)
- Bio-Interfaces, Inc. (17 510(k)s)
- Bio-Logic Systems Corp. (45 510(k)s)
- Bio-Med Corp. (5 510(k)s)
- Bio-Med Devices, Inc. (14 510(k)s)
- Bio Med Sciences, Inc. (10 510(k)s)
- Bio-Med USA, Inc. (11 510(k)s)
- Bio-Medical Devices, Inc. (7 510(k)s)
- Bio-Medical Research, Ltd. (36 510(k)s, 1 De Novo)
- Bio Medicus, Inc. (15 510(k)s)
- Bio Mega Diagnostic, Inc. (5 510(k)s)
- Bio-Plexus, Inc. (6 510(k)s)
- Bio Protech, Inc. (17 510(k)s)
- Bio Quantum Technologies, Inc. (6 510(k)s)
- Bio-Rad (319 510(k)s, 1 PMA)
- Bio-Rad, Diagnostics Grp. (6 510(k)s)
- Bio-Rad Laboratories, Inc. (127 510(k)s, 4 PMA, 1 De Novo)
- Bio-Research Associates, Inc. (10 510(k)s)
- Bio-Scan, Inc. (6 510(k)s)
- Bio-Tek Instruments, Inc. (37 510(k)s)
- Bio-Vascular, Inc. (26 510(k)s)
- Biobot Surgical Pte., Ltd. (7 510(k)s)
- Biocardia, Inc. (6 510(k)s)
- Biocartis Us, Inc. (1 PMA)
- Biocell Laboratories, Inc. (6 510(k)s)
- Biocheck, Inc. (14 510(k)s)
- Biochem International, Inc. (28 510(k)s)
- Biochemical Diagnostic, Inc. (5 510(k)s)
- Biochemical Trade, Inc. (20 510(k)s)
- Biocircuits Corp. (8 510(k)s)
- Bioclinical Group (9 510(k)s)
- Bioclinical Laboratory Services, Inc. (6 510(k)s)
- Bioclinical Systems, Inc. (13 510(k)s)
- Bioclone Australia Pty , Ltd. (10 510(k)s)
- Biocompatibles, Inc. (6 510(k)s)
- Biocompatibles UK Limited (5 510(k)s)
- Biocomposites, Ltd. (27 510(k)s)
- Biocontrol Technology, Inc. (2 510(k)s, 1 PMA)
- Biodan Medical Systems, Ltd. (20 510(k)s)
- Biodenta Swiss AG (11 510(k)s)
- Bioderm, Inc. (14 510(k)s)
- Biodermis Corp. (5 510(k)s)
- Biodex Corp. (7 510(k)s)
- Biodex Medical Systems, Inc. (9 510(k)s)
- Biodiagnostic Intl (11 510(k)s)
- Biodynamic Technologies, Inc. (30 510(k)s)
- Biodynamics Corp. (21 510(k)s)
- Biofilm, Inc. (17 510(k)s)
- Biofire Defense, LLC (8 510(k)s, 2 De Novo)
- Biofire Diagnostics, LLC (31 510(k)s, 4 De Novo)
- Biogenex Laboratories (12 510(k)s, 1 PMA)
- Biogennix, LLC (9 510(k)s)
- BioHorizons Implant Systems, Inc. (41 510(k)s)
- Biohytech International, Inc. (7 510(k)s)
- Bioject, Inc. (9 510(k)s)
- Biokit, S.A. (23 510(k)s)
- Biokit USA, Inc. (16 510(k)s)
- Bioland Technology, Ltd. (8 510(k)s)
- Biolase, Inc. (10 510(k)s)
- Biolase Technology, Inc. (31 510(k)s)
- Biolinq Incorporated (1 510(k)s, 1 De Novo)
- Biolitec, Inc. (28 510(k)s, 1 PMA)
- Biolitec Medical Devices, Inc. (9 510(k)s)
- Biolog, Inc. (6 510(k)s)
- Biological Corp. of America (6 510(k)s)
- Biological & Environmental Control Laboratories (20 510(k)s)
- Biological Signal Processing, Ltd. (5 510(k)s)
- Biologically Oriented Prostheses (9 510(k)s)
- Biologics Intl., Inc. (9 510(k)s)
- Biolucent, Inc. (6 510(k)s)
- Biomagnetic Technologies, Inc. (8 510(k)s)
- Biomaterials Korea, Inc. (5 510(k)s)
- Biomatlante (8 510(k)s)
- Biomedia, Inc. (19 510(k)s)
- Biomedica, Inc. (19 510(k)s)
- Biomedical Devices, Inc. (7 510(k)s)
- Biomedical Diagnostics (Bmd) SA (10 510(k)s)
- Biomedical Dynamics, Inc. (10 510(k)s)
- Biomedical Ent., Inc. (13 510(k)s)
- Biomedical Enterprises, Inc. (10 510(k)s)
- Biomedical Life Systems, Inc. (37 510(k)s)
- Biomedics (10 510(k)s)
- Biomedix, Inc. (11 510(k)s)
- Biomerica, Inc. (10 510(k)s)
- bioMerieux, Inc. (254 510(k)s, 3 PMA, 1 De Novo)
- Biomerieux S.A. (16 510(k)s)
- Biomerieux Vitek, Inc. (49 510(k)s, 1 PMA)
- Biomerix Corporation (6 510(k)s)
- Biomet, Inc. (445 510(k)s, 1 PMA)
- Biomet 3i, Inc. (32 510(k)s)
- Biomet Manufacturing Corp (128 510(k)s, 1 PMA)
- Biomet Microfixation (30 510(k)s, 1 PMA)
- Biomet Orthopedics, Inc. (41 510(k)s)
- Biomet Spine (23 510(k)s)
- Biomet Spine (Aka Ebi, LLC) (13 510(k)s)
- Biomet Sports Medicine (13 510(k)s)
- Biomet Trauma (7 510(k)s)
- Biometer Intl. A/S (9 510(k)s)
- Biometric Products, Inc. (5 510(k)s)
- Biomimetic Therapeutics, LLC (1 PMA)
- Biomira, Inc. (1 PMA)
- Bion Ent., Ltd. (14 510(k)s)
- Bioness, Inc. (13 510(k)s)
- Bionet Co., Ltd. (11 510(k)s)
- Bionetic Laboratory Products (8 510(k)s)
- Bionike Laboratories, Inc. (6 510(k)s)
- Bionime Corporation (21 510(k)s)
- Bionix Development Corp. (13 510(k)s)
- Bionomy, Inc. (5 510(k)s)
- Bionostics, Inc. (49 510(k)s)
- Bionova Medical, Inc. (6 510(k)s)
- Bionx Implants, Inc. (30 510(k)s)
- Biophor Diagnostics, Inc. (7 510(k)s)
- Biophotas, Inc. (6 510(k)s)
- Biophysic Medical, Inc. (11 510(k)s)
- Bioplate, Inc. (23 510(k)s)
- Biopool AB (13 510(k)s)
- Biopro, Inc. (41 510(k)s)
- Biopro (M) Sdn Bhd (5 510(k)s)
- Biopsy Sciences, LLC (8 510(k)s)
- Biopsys Medical, Inc. (15 510(k)s)
- Bioquest (2 510(k)s, 1 PMA)
- Biorent Diagnostic, Inc. (11 510(k)s)
- Bioretec, Ltd. (9 510(k)s, 1 De Novo)
- Bios S.R.L. (14 510(k)s)
- Biosafe Laboratories, Inc. (6 510(k)s)
- Biosafety Systems, Inc. (8 510(k)s)
- Biosan Laboratories, Inc. (10 510(k)s)
- Bioscientific (16 510(k)s)
- Bioseal (10 510(k)s)
- Biosearch Medical Products, Inc. (70 510(k)s)
- Biosense Webster, Inc. (76 510(k)s, 8 PMA)
- Biosensor Corp. (10 510(k)s)
- Biosensors International USA, Inc. (1 PMA)
- Biosite Incorporated (45 510(k)s, 1 De Novo)
- Biosonics, Inc. (3 510(k)s, 1 PMA)
- Biosound, Inc. (39 510(k)s)
- Biosound Esaote, Inc. (20 510(k)s)
- Biospace Corporation Limited (9 510(k)s)
- Biosphere Medical, Inc. (8 510(k)s)
- Biosphere Medical, S.A. (9 510(k)s, 1 De Novo)
- Biostar, Inc. (6 510(k)s)
- Biostar Medical Products, Inc. (5 510(k)s)
- Biostim, Inc. (5 510(k)s)
- Biostructures, LLC (5 510(k)s)
- Biosurge, Inc. (5 510(k)s)
- Biotecx Laboratories, Inc. (15 510(k)s)
- Biotek Solutions, Inc. (6 510(k)s)
- Biotem Co., Ltd. (6 510(k)s)
- Bioteque Corp. (14 510(k)s)
- Bioteque America, Inc. (10 510(k)s)
- Biotest Diagnostics Corp. (5 510(k)s)
- Biotest Medical Corp. (10 510(k)s)
- Biotex, Inc. (10 510(k)s)
- Biotope, Inc. (7 510(k)s)
- Biotrack, Inc. (16 510(k)s)
- Biotricity (5 510(k)s)
- Biotrine Corp. (6 510(k)s)
- Biotrol, USA, Inc. (46 510(k)s)
- Biotron , Ltd. (5 510(k)s)
- Biotronik, Inc. (103 510(k)s, 6 PMA)
- Biotronik AG (1 510(k)s, 4 PMA)
- Biotronik GmbH & Co. KG (1 PMA)
- Biotronik Nro, Inc. (1 PMA)
- Biotronik Sales, Inc. (41 510(k)s)
- Biovation, Inc. (11 510(k)s)
- Bioventus, LLC (7 510(k)s, 2 PMA)
- Bioview , Ltd. (5 510(k)s)
- Biowave Corporation (8 510(k)s)
- Biowhittaker Molecular Applications, Inc. (10 510(k)s)
- Bip USA, Inc. (7 510(k)s)
- Bipore, Inc. (10 510(k)s)
- Bird Life Design (7 510(k)s)
- Bird Products Corp. (35 510(k)s)
- Birtcher Corp. (27 510(k)s)
- Birtcher Medical Systems, Inc. (13 510(k)s)
- Bisco, Inc. (88 510(k)s)
- Bissell Medical Products, Inc. (6 510(k)s)
- Bistos Co., Ltd. (11 510(k)s)
- Bivona Medical Technologies (50 510(k)s)
- Bk Medical Aps (9 510(k)s)
- Bk Meditech, Co., Ltd. (11 510(k)s)
- Bl Healthcare, Inc. (5 510(k)s)
- Black & Decker(Tm) (11 510(k)s)
- Blackstone Medical, Inc. (45 510(k)s)
- Blease Medical Equipment , Ltd. (5 510(k)s)
- Block Drug Company, Inc. (10 510(k)s)
- Block Medical, Inc. (12 510(k)s)
- Blockade Medical (6 510(k)s)
- Bloomex International, Inc. (16 510(k)s)
- Bloxr Corporation (2 510(k)s, 1 De Novo)
- Blublocker Corp. (7 510(k)s)
- Blue Belt Technologies, Inc. (22 510(k)s)
- Blue Ortho (9 510(k)s)
- Blue Ridge Media Co. (11 510(k)s)
- Blue Sky Bio, LLC (21 510(k)s)
- Bluegrass Vascular Technologies, Inc. (1 De Novo)
- Bluewind Medical , Ltd. (3 510(k)s, 1 De Novo)
- Bm Korea Co., Ltd. (6 510(k)s)
- BMC Medical Co., Ltd. (7 510(k)s)
- Bmt, Inc. (1 PMA)
- Bmw Medical, Inc. (5 510(k)s)
- Board of Directors, Albert Browne , Ltd. (5 510(k)s)
- Boddingtons Plastics, Ltd. (5 510(k)s)
- Body Clock Health Care, Ltd. (7 510(k)s)
- Body Therapeutics, Inc. (5 510(k)s)
- Bodycad Laboratories, Inc. (16 510(k)s)
- Bodystat , Ltd. (8 510(k)s)
- Boehringer Laboratories (44 510(k)s)
- Boehringer Mannheim Corp. (340 510(k)s, 1 PMA)
- Bolder Surgical, LLC (5 510(k)s)
- Bolton Medical, Inc. (1 510(k)s, 3 PMA)
- Bomed Medical Mfr., Ltd. (8 510(k)s)
- Bonart Co., Ltd. (14 510(k)s)
- Bone Health Technologies, Inc. (1 De Novo)
- Bone Solutions, Inc. (9 510(k)s)
- Bonebridge AG (10 510(k)s)
- Bonesupport AB (6 510(k)s, 1 De Novo)
- Bonraybio Co., Ltd. (5 510(k)s)
- Bontech, Inc. (5 510(k)s)
- Bonutti Research, Inc. (17 510(k)s)
- Boots-Celltech Diagnostics, Inc. (20 510(k)s)
- Bosch Hearing Instruments, Inc. (7 510(k)s)
- Bose Corporation (1 510(k)s, 1 De Novo)
- Boston Aesthetics, Inc. (6 510(k)s)
- Boston Biomedica, Inc. (12 510(k)s)
- Boston Medical Corp. (8 510(k)s)
- Boston Medical Products, Inc. (33 510(k)s)
- Boston Pacific Medical, Inc. (11 510(k)s)
- Boston Scientific Corp (730 510(k)s, 75 PMA, 2 De Novo)
- Boston Scientific /International Technologies (5 510(k)s)
- Boston Scientific/Medi-Tech (5 510(k)s)
- Boston Scientific Neuromodulation (10 510(k)s, 1 PMA)
- Boston Scientific Scimed, Inc. (35 510(k)s, 5 PMA)
- Boston Scientific, Target (19 510(k)s)
- Boston Surgical Products, Inc. (17 510(k)s)
- Bourns Medical Systems, Inc. (9 510(k)s)
- Bovie Medical Corporation (23 510(k)s)
- Bowen & Company, Inc. (14 510(k)s)
- Brachyfoam, Inc. D/B/A Advaray (1 De Novo)
- Brady Medical Products Co. (5 510(k)s)
- Braebon Medical Corp. (8 510(k)s)
- Braemar, Inc. (10 510(k)s)
- Brahms GmbH (1 510(k)s, 1 De Novo)
- Brahms Diagnostica, LLC (6 510(k)s)
- Brahms GmbH, Part of Thermo Fisher Scientific (1 De Novo)
- Brain Temp, Inc. (1 De Novo)
- Braincool AB (3 510(k)s, 1 De Novo)
- Brainlab (7 510(k)s)
- Brainlab AG (135 510(k)s)
- Brainlab Med. Computersysteme GmbH (5 510(k)s)
- Brainomix Limited (13 510(k)s)
- Brainscope Company, Inc. (7 510(k)s, 1 De Novo)
- Brainsway , Ltd. (11 510(k)s)
- Brainways , Ltd. (1 De Novo)
- Branan Medical Corp. (24 510(k)s)
- Brattle Instrument Corp. (7 510(k)s)
- Braun GmbH (7 510(k)s)
- Breas Medical AB (15 510(k)s)
- Breathe Technologies, Inc. (8 510(k)s)
- Breg, Inc. (16 510(k)s)
- Breit Laboratories, Inc. (5 510(k)s)
- Brennen Medical, Inc. (20 510(k)s)
- Brenner Metal Prod Corp. (6 510(k)s)
- Brentwood Instruments, Inc. (21 510(k)s)
- Brentwood Medical Technology Corp. (7 510(k)s)
- Brevet, Inc. (6 510(k)s)
- Bridge TO Life, Ltd. (6 510(k)s, 1 De Novo)
- Bridgepoint Medical (14 510(k)s)
- Bridger Biomed, Inc. (7 510(k)s)
- Brightheart (5 510(k)s)
- Brightway Holdings Sdn. Bhd. (24 510(k)s)
- Brilliant Ray Intl., Inc. (7 510(k)s)
- Brimfield Scientific Instruments (5 510(k)s)
- Briox Technologies, Inc. (6 510(k)s)
- Britt Corp., Inc. (17 510(k)s)
- Brivant, Ltd. (7 510(k)s)
- Brixton Biosciences (1 De Novo)
- Broadwest Corp. (6 510(k)s)
- Broncus Medical, Inc. (7 510(k)s)
- Broncus Technologies, Inc. (11 510(k)s)
- Brosmed Medical Co., Ltd. (10 510(k)s)
- Browne Corp. (7 510(k)s)
- Browne Medical Systems, Inc. (7 510(k)s)
- Bruin Biometrics, LLC (1 De Novo)
- Bruker Daltonik GmbH (2 510(k)s, 1 De Novo)
- Bruker Medical Imaging, Inc. (7 510(k)s)
- Bruno Independent Living Aids, Inc. (12 510(k)s)
- Bryan Corp. (5 510(k)s)
- Bt Medical Co., Inc. (6 510(k)s)
- Btc Diagnostics, Inc. (5 510(k)s)
- Btg International, Inc. (6 510(k)s)
- BTL Industries, Inc. (46 510(k)s)
- Buckman Co., Inc. (111 510(k)s)
- Buffalo Dental Mfg. Co., Inc. (11 510(k)s)
- Buffalo Filter Co., Inc. (24 510(k)s)
- BunkerHill Health (8 510(k)s)
- Bunnell, Inc. (1 PMA)
- Burdick Corp. (44 510(k)s)
- Burditt & Calkins-Siemens-Elema (10 510(k)s)
- Burke, Inc. (7 510(k)s)
- Burke Neutech, Inc. (7 510(k)s)
- Burron Medical, Inc. (9 510(k)s)
- Burron Medical Products, Inc. (41 510(k)s)
- Burroughs Wellcome Co. (17 510(k)s)
- Burton Medical Products Corp. (15 510(k)s)
- Busse Hospital Disposables, Inc. (35 510(k)s)
- Butterfly Network, Inc. (6 510(k)s)
- Byrne Medical, Inc. (12 510(k)s)
- Byron Medical (27 510(k)s)