Ximed Medical Systems: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Ximed Medical Systems” (first 1989, latest 1996), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 95 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 4 | 4 |
| GEX | Powered Laser Surgical Instrument | 4 | 4 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| JOL | Catheter And Tip, Suction | 1 | 1 |
Review panels
Most recent Ximed Medical Systems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K943014 | BALLOON ELECTROSURGICAL PROBES AND DEVICES | GEI | 1996-03-11 | 626 |
| K946377 | ELECTROPROBE SINGLE USE ELECTROSURGICAL PROBES | GEI | 1995-03-24 | 95 |
| K933757 | HAND-HELD IRRIGATION PUMP | BTA | 1994-08-26 | 408 |
| K933458 | SURGICAL TROCARS | GCJ | 1994-05-05 | 295 |
| K922714 | UNIVERSAL IRRIGATION & SUCTION TUBING SET | JOL | 1993-08-03 | 424 |
| K922523 | BIPOLAR ELECTROSURGICAL PROBES & INSTRUMENTS | GEI | 1992-09-23 | 118 |
| K903812 | ELECTROPROBE SINGLE-USE SURGICAL PROBE | GEI | 1990-09-20 | 31 |
| K900463 | LASER DELIVERY SYSTEMS, FIBEROPTICS & CONTACT TIPS | GEX | 1990-03-22 | 50 |
| K892933 | INFRALASE-LASERGUIDE DELIVERY SYSTEM | GEX | 1989-06-22 | 62 |
| K890775 | INFRALASE - LASERGUIDE DELIVERY SYSTEM | GEX | 1989-04-21 | 65 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ximed Medical Systems.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Ximed Medical Systems?
FDA lists 11 510(k) clearances under the applicant name “Ximed Medical Systems” (first 1989, latest 1996), across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ximed Medical Systems?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ximed Medical Systems is 95 days.
Which FDA product codes appear under Ximed Medical Systems?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 4); GEX (Powered Laser Surgical Instrument, 4); BTA (Pump, Portable, Aspiration (Manual Or Powered), 1).
Next steps
- See all 11 Ximed Medical Systems clearances with predicates and recalls
- Run predicate analysis for product code GEI, Ximed Medical Systems's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.