13 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Twin-Pass Dual Access Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Manifold
FDA UDI
ARGON MEDICAL DEVICES, INC.·00886333207039·3 Port Manifold - Right/Off/Open Body - 500 PSI
ECHO BI-METRIC MICROPLASTY HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304698017·
CONMED
FDA UDI
Conmed Corporation·10845854021507·OSCILLATING SAW BLADE 19/13 X 1.19 X 90 MM
BILLY BOY MALE LATEX CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ENDOGATOR ADVANTAGE IRRIGATION PUMP
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·October 6, 2008
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 27, 2013
ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code FGE·August 5, 2011
CR TIBIAL INSERT SZ 2, 9MM, SLOPE ++
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·December 13, 2022
UNKNOWN METAL COMPONENT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·July 7, 2025
PS TIBIAL INSERTS SZ 2, 13MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·July 7, 2025
Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. Order Number (GPN): G20003 Reference Part Number (RPN): LR-CLP001
FDA Enforcement
Class II
·Ongoing·Cook Vandergrift, Inc.·September 13, 2023