16 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.

KALARE DIAGNOSTIC X-RAY TABLE SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

TOSHIBA Kalare Diagnostic X-Ray System K110785

FDA Recall
Terminated ·Toshiba American Medical Systems Inc·Product code JAA·April 3, 2013

TOSHIBA Kalare Diagnostic X-Ray System K110785

FDA Enforcement
Class II ·Terminated·Toshiba American Medical Systems Inc·July 17, 2013

JOBST Men's Dress

FDA UDI
BSN MEDICAL, INC.·00035664107857·MEN'S DRESS 8-15 MM HG KNEE HIGH CLOSED TOE MED...

INSIGHT

FDA UDI
CARESTREAM HEALTH, INC.·40889978110786·INSIGHT 50PKT 22x35 film IB01

Leva® Anterior Expandable Spacer System

FDA UDI
Spine Wave, Inc.·10840642109337·Spacer, 38 mm (W) x 30 mm (D) x 15 mm (H), 8° L...

Marina Medical

FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306818332·AXS 1" to 1" Post Clamp

KSEA DION-GRACIA SET

FDA 510(k)
FDA Class 2 ·Cardiovascular

BONART MODEL ART-IM1 IMPLANTOR SYSTEM & ACCESSORIES

FDA 510(k)
FDA Class 1 ·Dental

CHARGING SYSTEM

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 9, 2013

530G INSULIN PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OZO·September 23, 2014

SYNCHRON® CX9 ALX CLINICAL SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code JJE·June 1, 2011

BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·March 9, 2018

INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL labels --- Carestream Health Inc.

FDA Recall
Terminated ·Carestream Health Inc.·Product code IWZ·July 2, 2014

INSTAT - Agent, Absorbable Hemostatic, Collagen Based INSTAT MCH is recommended for use in surgical procedures (other than Urological and Ophthalmological surgery) as an adjunct to hemostatis when control of bleeding by ligature or conventional procedures is ineffective or impractical.

FDA Enforcement
Class II ·Terminated·Integra LifeSciences Corporation·May 22, 2013

INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL labels --- Carestream Health Inc.

FDA Enforcement
Class III ·Terminated·Carestream Health Inc.·August 13, 2014