16 results · 31ms · Sources: EU EUDAMED, US FDA

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S.I.N. Instrument Kits

FDA 510(k)
FDA Class 2 ·General Hospital

BioHorizons

FDA UDI
BIOHORIZONS IMPLANT SYSTEMS, INC·00847236002077·External 4.0mm x 4.5mm Flared Healing Abutment

BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 18, 2021

K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85

FDA 510(k)
FDA Class 2 ·Cardiovascular

CONCENTRIC BALLOON GUIDE CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 18, 2021

BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 18, 2021

ITREL 4

FDA Adverse Event
Malfunction ·MEDTRONIC NEUROMODULATION·Product code LGW·July 15, 2015

FG 6301 DUAL CHNL VOL INF PUMP2M8064 SERVICE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·October 29, 2008

OT ULTRALINK METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·August 15, 2011

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE·Product code FKX·July 9, 2013

SHORELINE ACS, WAVEFORM C

FDA Adverse Event
Injury ·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025

SHORELINE ACS, WAVEFORM C

FDA Adverse Event
Injury ·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025

SHORELINE ACS, WAVEFORM C

FDA Adverse Event
Injury ·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025

Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.

FDA Enforcement
Class II ·Terminated·Unomedical As·July 1, 2015

DRX Revolution Mobile X-Ray System

FDA Enforcement
Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023