12 results
·
20ms
·
Sources: EU EUDAMED, US FDA
ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II.
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
3M™ Victory Series™
FDA UDI
3M UNITEK CORPORATION·00652221116086·3M™ Victory Series™ First Molar Bands, 952-470,...
Great Basin Staph ID/R Blood Culture Panel
FDA 510(k)
FDA Class 2
·Microbiology
F1 SERIES DENTAL CHAIRS WITH OPERATIVE UNIT
FDA 510(k)
FDA Class 1
·Dental
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·February 9, 2013
IUNI/IDUO TIBIAL IMPACTOR
FDA Adverse Event
Malfunction
·CONFORMIS·Product code HSX·January 4, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 23, 2014
M2A-MAGNUM MOD HD SZ 44MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·August 8, 2018
E1 RINGLOC MAX-ROM ACETABULAR LINER
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·August 8, 2018
MODULAR HEAD
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·August 8, 2018
UNKNOWN LINER
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·August 8, 2018
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015