22 results · 21ms · 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.

INSTANT-VIEW MORPHINE (2000) URINE DIP STRIP TEST

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

Batrik In-Brush Twisted Wire Brushes

FDA UDI
Batrik Medical Manufacturing Inc·00690521005587·Brush\6Fraizier\BD-2.00mm\BL-25.4mm\OL-250mm - ...

Kalitec Special

FDA UDI
Kalitec Direct LLC·B073DRK0100190·SNII Tap, 7.50mm

InTess C Cervical Cage System

FDA UDI
Kalitec Direct LLC·B07309K0100090·Tamp, Oblique Kicker

Kalitec Special

FDA UDI
Kalitec Direct LLC·B073DRK0100090·Dilator Sleeve, Screwdriver

ADVIA CENTAUR CP TROPONIN ULTRA (TNI ULTRA)

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·February 6, 2014

NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M

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

RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO

FDA 510(k)
FDA Class 2 ·Physical Medicine

ADVIA CENTAUR XP TROPONIN ULTRA ASSAY

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·March 14, 2014

ADVIA CENTAUR XP TROPONIN ULTRA ASSAY

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·February 27, 2014

ADVIA CENTAUR XP TROPONIN ULTRA ASSAY

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·February 13, 2014

HEARTMATE 3 LVAS IMPLANT KIT

FDA Adverse Event
Injury ·THORATEC CORPORATION·Product code DSQ·January 20, 2023

AXSYM DIGOXIN III

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.·Product code KXT·May 11, 2007

OT ULTRALINK METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 19, 2013

ACCU-CHEK ® COMPACT TEST DRUM

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·March 8, 2011

ADVIA CENTAUR TROPONIN ULTRA ASSAY

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·January 21, 2014

ADVIA CENTAUR CP TROPONIN ULTRA ASSAY

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·April 2, 2014

ADVIA CENTAUR CP TROPONIN ULTRA ASSAY

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·April 15, 2014

ADVIA CENTAUR XP TROPONIN ULTRA ASSAY

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·May 1, 2014

Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

FDA Enforcement
Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012