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

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Venus BlissMAX

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Philips

FDA UDI
Sbo Hearing A/S·05714464011292·PHILIPS HEARLINK 2.3.0 ANDROID

HOBBS MEDICAL, INC.

FDA registration
HOBBS MEDICAL, INC.·13 products·🇺🇸 United States

DANA REUSABLE BOWIE TEST PACK FOR DANA BOWIE DICK INDICATORS

FDA 510(k)
FDA Class 2 ·General Hospital

ALBAHEALTH C.A.L.M. SLEEVE, MODEL 59001

FDA 510(k)
FDA Class 2 ·General Hospital

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 13, 2025

SERVO-U

FDA Adverse Event
Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·June 25, 2019

REAMER SHAFT, AO FITTING BIXCUT Ø8,0X448 MM

FDA Adverse Event
Malfunction ·STRYKER TRAUMA KIEL·Product code LXH·November 3, 2014

E SERIES DEFIBRILLATOR

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·July 18, 2011

HELICAL BLADE COUPLING SCREW

FDA Adverse Event
Malfunction ·SYNTHES·Product code LXH·July 11, 2013

ACCESS 2 IMMUNOASSAY SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code MMI·September 7, 2012

MICROBIOLOGY BRUSH

FDA Adverse Event
Malfunction ·HOBBS MEDICAL, INC.·Product code FDA·November 12, 2024

ACCESS 2 IMMUNOASSAY SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code MMI·September 11, 2012

UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code MMI·August 13, 2012

ACCESS 2 IMMUNOASSAY SYSTEM

FDA Adverse Event
Injury ·BECKMAN COULTER, INC.·Product code MMI·September 11, 2012

ACCESS 2 IMMUNOASSAY SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code MMI·September 12, 2012

ACCESS 2 IMMUNOASSAY SYSTEM

FDA Adverse Event
Injury ·BECKMAN COULTER, INC.·Product code MMI·September 11, 2012

BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

FDA Enforcement
Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021