11 results
·
19ms
·
Sources: EU EUDAMED, US FDA
BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772813872·GENUMEDI PRO SILVER SIZE VII
ArgenZ Anterior 95x16 #4
FDA UDI
ARGEN CORPORATION, THE·D818121270·Dental porcelain/ceramic restoration kit
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780180296·Integra® Jarit® Fell Needle Holder, 5-1/8", Car...
SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311
FDA 510(k)
FDA Class 2
·General Hospital
ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-2
FDA 510(k)
FDA Class 2
·Neurology
PULSE GEN MODEL UNK
FDA Adverse Event
Malfunction
·CYBERONICS·Product code LYJ·May 20, 2013
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
FDA Adverse Event
Injury
·ALLERGAN·Product code LTI·September 22, 2014
ASR ACETABULAR CUPS 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 1, 2011
ALK (D5F3)
FDA Adverse Event
Malfunction
·VENTANA MEDICAL SYSTEMS INC.·Product code NJT·August 22, 2025
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018