Medical Device Manufacturer · US , Sylmar , CA

Maersk Medical A/S

9 submissions · 9 cleared · Since 1998
9
Total
9
Cleared
0
Denied

Maersk Medical A/S — FDA 510(k) Submissions

Maersk Medical A/S has submitted 9 FDA 510(k) premarket notifications since 1998, of which 9 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Electrode, Electrocardiograph, Set, Administration, Intravascular, Collector, Urine, (and Accessories) For Indwelling Catheter . Use the specialty filter in the sidebar to narrow results.

9 devices
1–9 of 9
PARADIGM QUICK-SET INFUSION SET
K011071 · FPA Set, Administration,... · General Hospital
Jun 2001 59d
PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380
K002138 · FPA Set, Administration,... · General Hospital
Aug 2000 43d
DISPOSABLE ECG MONITORING ELECTRODES, MODEL 4110, 4140
K990110 · DRX Electrode,... · Cardiovascular
Dec 1999 327d
DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4520, 4535, 4570
K990111 · DRX Electrode,... · Cardiovascular
Dec 1999 327d
DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4060, 4610
K990112 · DRX Electrode,... · Cardiovascular
Dec 1999 327d
DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533, 4539, 4540, AND 4560
K990113 · DRX Electrode,... · Cardiovascular
Dec 1999 327d
DISPOSABLE ECG MONITORING ELECTRODES, MODELS, 4420, 4440
K990115 · DRX Electrode,... · Cardiovascular
Dec 1999 327d
MAERSK MEDICAL CONTOUR INFUSION SET
K991759 · FPA Set, Administration,... · General Hospital
Jun 1999 32d
4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG
K973364 · KNX Collector, Urine, (and... · Gastroenterology & Urology
Mar 1998 190d
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