17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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