23 results · 23ms · 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.

IMMULITE 2000 3GALLERGY SPECIFIC IGE

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code DHB·May 22, 2018

IMMULITE 2000 SPECIFIC ALLERGENS

FDA 510(k)
FDA Class 2 ·Immunology

IMMULITE 2000 3GALLERGY SPECIFIC IGE

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code DHB·May 22, 2018

PullUp Probe Cover Kit

FDA UDI
PROTEK MEDICAL PRODUCTS, INC.·00841912105366·

OsteoMed

FDA UDI
OSTEOMED LLC·00845694000277·1.2mm x 6mm OMI Orthodontic Anchor Screw

NIDO Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07315K0112060·Tap, 6.50mm

VADER Pedicle System, Rod, Carbon/PEEK, Curved, Ø 6.0 r120 x 060 mm

FDA UDI
icotec AG·07640172551783·VADER Pedicle System, Rod, Carbon/PEEK, Curved,...

CosmoLock Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07311K0112060·Tap, 8.5 mm

InSePtion MIS Fixation System

FDA UDI
Kalitec Direct LLC·B07314K0112060·Punch, 6 and 8 mm

PARALLAX BONE AND VERTEBRAL BODY BIOPSY AND INFUSION NEEDLES

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

ALTERNANAS PROCESSING SYSTEM, CH 2000 CARDIAC DIAGNOSTIC SYSTEM, HEARTWAVE ALTERNANS PROCESSING SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

I-STAT ACT CELITE CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE·Product code JBP·December 10, 2012

PINNACLE MTL INS NEUT36IDX54OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·March 26, 2013

SPRINT FIDELIS

FDA Adverse Event
Death ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 16, 2011

ACUVUE OASYS W/HYDRACLEAR

FDA Adverse Event
Injury ·VISTAKON·Product code LPL·March 28, 2008

THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

FDA Adverse Event
Death ·THORATEC CORPORATION·Product code DSQ·April 10, 2026

THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

FDA Adverse Event
Injury ·THORATEC CORPORATION·Product code DSQ·April 10, 2026

RESONANCE STENT SET

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FAD·October 20, 2025

CryoValve, Alt Pulmonary Valve & Conduit

FDA Recall
Terminated ·Cryolife Inc·Product code MIE·November 19, 2003

Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Corporation·February 28, 2018