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Maersk Medical A/S

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
13
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K011071PARADIGM QUICK-SET INFUSION SETJune 7, 2001
K004028ARGLAES-AB ANTIMICROBIAL BARRIER POWDER DRESSINGMarch 27, 2001
K002138PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380August 29, 2000
K990112DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4060, 4610December 6, 1999
K990111DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4520, 4535, 4570December 6, 1999
K990110DISPOSABLE ECG MONITORING ELECTRODES, MODEL 4110, 4140December 6, 1999
K990113DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533, 4539, 4540, AND 4560December 6, 1999
K990115DISPOSABLE ECG MONITORING ELECTRODES, MODELS, 4420, 4440December 6, 1999
K990810ARGLAES-AB ANTIMICROBIAL BARRIER FILM DRESSING & ISLAND DRESSINGSeptember 17, 1999
K991759MAERSK MEDICAL CONTOUR INFUSION SETJune 25, 1999
K9733644L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAGMarch 17, 1998
K973657ARGLAES-AB ANTIMICROBIAL BARRIER ISLAND DRESSINGDecember 1, 1997
K970566ARGLAES FILM DRESSINGJuly 29, 1997