16 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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