17 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Branchor X Balloon Guide Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704283167·DEAVER RETRACTOR HOLLOW 2" X 12"
LoFric® Hydro-Kit™
FDA UDI
Wellspect AB·07392532148552·Single Use Urinary Catheter LoFric Hydro-Kit Co...
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780185000·Integra® Jarit® Cobb-Type Spinal Gouge, 9-1/4",...
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690192299·Revision Knee Reamer Spiral Fluted - Zimmer 24mm
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011251240200·ceraMotion® Ti Chroma Concept Dentin 10, 20 g /...
PERFORMER INTRODUCER
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·January 16, 2019
extriCARE Negative Pressure Wound Therapy Gel Strip - 8pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 7pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 6pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 5pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 4pc
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Mariner Cap System
FDA 510(k)
FDA Class 2
·Orthopedic
Vu aPod™ - L
FDA UDI
Seaspine Orthopedics Corporation·10889981046897·LATERAL TRIAL, WIDE, LORDOTIC, 12mm X 23mm X 40...
NA
FDA UDI
aap Implantate AG·04042409261428·Cortical Screw 2.5, small head T8, self-tapp. L 40
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·November 14, 2014
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 9, 2011
2520274-2013-04613
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·July 29, 2013
UNK STEM TRIAL
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LXH·November 25, 2025
PERFORMER INTRODUCER
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·January 16, 2019
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025