Maersk Medical A/S
Sylmar, CA, US
Maersk Medical A/S appears in FDA device records in Sylmar, CA. FDA records list 13 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 13
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 13 510(k) clearances for Maersk Medical A/S between 1997 and 2001. The busiest year on record is 1999, with 7. The most recent is 2001, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 2 |
| 1998 | 1 |
| 1999 | 7 |
| 2000 | 1 |
| 2001 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K011071 | PARADIGM QUICK-SET INFUSION SET | FPA | Substantially Equivalent | |
| K004028 | ARGLAES-AB ANTIMICROBIAL BARRIER POWDER DRESSING | FRO | Substantially Equivalent | |
| K002138 | PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380 | FPA | Substantially Equivalent | |
| K990115 | DISPOSABLE ECG MONITORING ELECTRODES, MODELS, 4420, 4440 | DRX | Substantially Equivalent | |
| K990113 | DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533, 4539, 4540, AND 4560 | DRX | Substantially Equivalent | |
| K990112 | DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4060, 4610 | DRX | Substantially Equivalent | |
| K990111 | DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4520, 4535, 4570 | DRX | Substantially Equivalent | |
| K990110 | DISPOSABLE ECG MONITORING ELECTRODES, MODEL 4110, 4140 | DRX | Substantially Equivalent | |
| K990810 | ARGLAES-AB ANTIMICROBIAL BARRIER FILM DRESSING & ISLAND DRESSING | FRO | Substantially Equivalent | |
| K991759 | MAERSK MEDICAL CONTOUR INFUSION SET | FPA | Substantially Equivalent | |
| K973364 | 4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG | KNX | Substantially Equivalent | |
| K973657 | ARGLAES-AB ANTIMICROBIAL BARRIER ISLAND DRESSING | MGP | Substantially Equivalent for Some Indications | |
| K970566 | ARGLAES FILM DRESSING | FRO | Substantially Equivalent for Some Indications |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
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