23 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-1006 170
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Nebulizers
FDA UDI
WESTMED, INC.·00709078014383·Small Volume Nebulizer Anti-Spill T W/7'Kink Re...
ACE
FDA UDI
ACE SURGICAL SUPPLY CO., INC.·00614950018628·FORCEP PROVIDENCE KELLY CURVED 5-1/2" 14CM
Procure
FDA UDI
Twin Med, LLC·10840330700457·Small Volume Nebulizer Anti-Spill T W/7'Kink Re...
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00262211·
BetaForce™
FDA UDI
Ortho Organizers, Inc.·00190707124656·BETAFORCE Beta³ Euro Lower 19x25 (10pk)
BetaForce
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730022271·Beta3 Euro Lower 19x25 10 archwires per pack
ANCURE EXPANDABLE SHEATH
FDA Adverse Event
Malfunction
·GUIDANT ENDOVASCULAR SOLUTIONS·Product code MIH·July 30, 2001
SERIES 7700 MOBILE C-ARM, COMPACT 7700 MOBILE C-ARM, COMPACT 7700 PLUS MOBILE C-ARM
FDA 510(k)
FDA Class 2
·Radiology
MALE LATEX COMDOM WITH DOTTED SURFACE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
WAVEWRITER ALPHA?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·July 21, 2025
IPC® HANDPIECE - XPS® STRAIGHTSHOT® M4
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ERL·November 15, 2015
UNKNOWN NEXGEN TIBIAL TRAY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·January 17, 2019
MICRODEBRIDER 1898200T IGS M4
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ERL·May 15, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·March 13, 2013
ARTICULEZE M HEAD 36MM -2
FDA Adverse Event
Injury
·DEPUY IN'TL., LTD.·Product code JDI·February 18, 2011
PFC SIGMA STAB INS SZ5 10MM
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code JWH·February 20, 2008
Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05-02954 K05-03094A K05T-00380C K05T-01674B K05T-01863 K05T-01915 K05T-01920F K05T-01955 K05T-02138 K05T-02138A K05T-02272G K05T-02272H K05T-02533 K05T-03153 K05T-03201
FDA Recall
Open, Classified
·Merit Medical Systems, Inc.·Product code PPD·December 4, 2025
Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05-02954 K05-03094A K05T-00380C K05T-01674B K05T-01863 K05T-01915 K05T-01920F K05T-01955 K05T-02138 K05T-02138A K05T-02272G K05T-02272H K05T-02533 K05T-03153 K05T-03201
FDA Enforcement
Class II
·Ongoing·Merit Medical Systems, Inc.·January 28, 2026
Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD, Inc.·August 8, 2012