Global Medical Products, Ltd.: FDA clearances and approvals
Global Medical Products, Ltd. has 6 FDA 510(k) clearances (first 1995, latest 1997), across 6 product codes in 5 review panels. Median 510(k) review time: 124 days.
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 |
|---|---|---|---|
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 1 | 1 |
| CAZ | Anesthesia Conduction Kit | 1 | 1 |
| DRC | Trocar | 1 | 1 |
| FCG | Biopsy Needle | 1 | 1 |
| FQH | Lavage, Jet | 1 | 1 |
| GDF | Guide, Needle, Surgical | 1 | 1 |
Review panels
- Anesthesiology (2)
- Cardiovascular (1)
- Gastroenterology and Urology (1)
- General Hospital (1)
- General and Plastic Surgery (1)
Most recent Global Medical Products, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K970916 | H.V. PULSE LAVAGE (L31 SERIES) | FQH | 1997-06-20 | 100 |
| K962821 | EPIDURAL ANESTHESIA KIT AND COMBINED SPINAL EPIDURAL ANESTHESIA KIT | CAZ | 1996-11-13 | 117 |
| K961444 | GLOBAL MEDICAL COMBINED SPINAL EPIDURAL KIT (GMA 1827 AND GMA 1725) | BSP | 1996-08-01 | 108 |
| K951448 | GLOBAL MEDICAL PRODUCTS POTTS COURNAND, SELDINGER STYLE NEEDLE, SINGLE, WINGED SINGLE WALL INTRODUCER NEEDLE | DRC | 1996-03-27 | 364 |
| K951421 | GLOBAL MEDICAL PRODUCTS CHIBA, FRANSEEN, WESTCOTT STYLE, MENGHINI, TURNER, GREENE NEEDLES | FCG | 1995-11-16 | 233 |
| K950311 | GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIRE | GDF | 1995-05-26 | 130 |
Recalls
openFDA lists no recalls under a recalling firm named Global Medical Products, Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Global Medical Products, Ltd. have?
Global Medical Products, Ltd. has 6 FDA 510(k) clearances (first 1995, latest 1997), across 6 product codes in 5 review panels.
How long does FDA take to clear Global Medical Products, Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Global Medical Products, Ltd.'s cleared 510(k)s is 124 days.
What devices does Global Medical Products, Ltd. make?
Its most frequent FDA product codes are BSP (Needle, Conduction, Anesthetic (W/Wo Introducer), 1); CAZ (Anesthesia Conduction Kit, 1); DRC (Trocar, 1).
Has Global Medical Products, Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Global Medical Products, Ltd. Related entities may recall under other names.
Next steps
- See all 6 Global Medical Products, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code BSP, Global Medical Products, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.