RESORBA Medical GmbH
NUERNBERG Bavaria, DE
RESORBA Medical GmbH appears in FDA device records in NUERNBERG Bavaria, DE. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for RESORBA Medical GmbH between 2014 and 2018. The busiest year on record is 2015, with 2. The most recent is 2018, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2014 | 1 |
| 2015 | 2 |
| 2018 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K181320 | Caprolon | GAM | Substantially Equivalent | |
| K143584 | PGA RESORBA, PGA RESOQUICK, GLYCOLON | GAM | Substantially Equivalent | |
| K143582 | MOPYLEN, RESOPREN, SILK, POLYESTER, NYLON, RESOLON, POLYAMIDE PSEUDO, STEEL | GAW | Substantially Equivalent | |
| K141072 | SUPOLENE | GAT | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9611459 | 3002807993 | RESORBA Medical GmbH | AM FLACHMOOR 16, NUERNBERG Bavaria D-90475 DE | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NABGauze / Sponge,Nonresorbable For External Use
- GAMSuture, Absorbable, Synthetic, Polyglycolic Acid
- GAPSuture, Nonabsorbable, Silk
- GAQSuture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
- GARSuture, Nonabsorbable, Synthetic, Polyamide
- GATSuture, Nonabsorbable, Synthetic, Polyethylene
- GAWSuture, Nonabsorbable, Synthetic, Polypropylene
- MXWSuture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain