17 results · 22ms · Sources: EU EUDAMED, US FDA

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coactiv+™ Antimicrobial Wound Gel

FDA 510(k)
FDA Unclassified ·Unknown

V-Strap Wrist Support

FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357232598·

UniTip High Resolution Catheter

FDA UDI
Unisensor AG·07640172970584·

UniTip High Resolution Catheter

FDA UDI
Unisensor AG·07640172970591·

INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

MAMMOTOME REOLVE DUAL VACUUM ASSISTED BIOPSY (VAB) SYSTEM

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·September 4, 2024

RF GEN OBSOLETE REPLACED BY 0406900000

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code GXD·August 16, 2011

MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code LXH·November 4, 2014

OT VERIO PRO PLUS METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 12, 2013

BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·August 28, 2023

BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·April 25, 2025

BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·April 30, 2025

syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60- Intended for Radiation Therapy Treatment Material Number: 10496180

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·September 22, 2021

Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024

MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

FDA Enforcement
Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

Model Number L111, ESSENTIO DR SL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025