19 results · 24ms · Sources: EU EUDAMED, US FDA

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ONTEX AND OTHER PROPRIETARY NAMES

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

EMT - Siemens Trauma - Red Bag

FDA UDI
Certified Safety Manufacturing, Inc.·00766588226033·EMT - Siemens Trauma - Red Bag

ELMED

FDA UDI
ELMED INCORPORATED·00842180164178·Lahey Hemostatic Forcep, Curved OL 140mm(5 1/2")

Kyocera Medical Technologies, Inc.

FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523166879·Initia Acetabular Standard Liner, E-CIMA 22-60/...

SA FLOWABLE ADHESIVE

FDA 510(k)
FDA Class 2 ·Dental

IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

BD INTIMA IV CATHETER

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS·Product code FOZ·May 16, 2007

LIFEPAK(R) 1000 DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·July 10, 2015

IMMULITE 2000

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CFP·January 23, 2012

IMMULITE 2000

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CFP·February 2, 2012

LIFEPAK® 1000 DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC. - 3015876·Product code MKJ·April 24, 2019

VECTORVISION FLUORO 3D

FDA Adverse Event
Other ·BRAINLAB AG·Product code HAW·May 15, 2013

ENRHYTHM DR

FDA Adverse Event
Injury ·MEDTRONIC MED REL, INC.·Product code DXY·June 14, 2011

VERSACARE

FDA Adverse Event
Malfunction ·HILL-ROM RITTER·Product code FNL·August 20, 2008

IMMULITE 2000 INSULIN

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS·Product code CFP·January 27, 2012

IMMULITE 2000 INSULIN

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS·Product code CFP·February 1, 2012

Model M4735A HeartStart XL Defibrillator//Monitor

FDA Recall
Terminated ·Philips Medical Systems·Product code MKJ·September 2, 2003

Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000

FDA Enforcement
Class I ·Ongoing·Covidien·November 8, 2023

Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty

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