12 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MEMORY METAL STAPLES, EASYCLIP
FDA 510(k)
FDA Class 2
·Orthopedic
ArgenZ HT+ 98x30 A3
FDA UDI
ARGEN CORPORATION, THE·D818122113·Dental porcelain/ceramic restoration kit
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690129899·PS-C Insert, Size 1 x 13mm
BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·May 4, 2018
GE VENUE 40 COMPACT DIAGNOSTIC ULTRASOUND
FDA 510(k)
FDA Class 2
·Radiology
3I DENTAL IMPLANT ACCESSORIES
FDA 510(k)
FDA Class 2
·Dental
ESOPHYX Z
FDA Adverse Event
Injury
·ENDOGASTRIC SOLUTIONS, INC.·Product code ODE·June 22, 2017
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·May 21, 2013
PLV-100
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·September 19, 2014
PFC CVD 10MM SZ4
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC.·Product code JWH·June 3, 2011
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
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