12 results
·
21ms
·
Sources: EU EUDAMED, US FDA
EMPI MODEL GLS 450, TENS
FDA 510(k)
FDA Class 2
·Neurology
JOBST Maternity
FDA UDI
BSN MEDICAL, INC.·04042809642674·OPAQUE MATERNITY 20-30 MM HG THIGH HIGH ZIG ZAG...
Zimmer M/L Taper Hip Prosthesis
FDA 510(k)
FDA Class 2
·Orthopedic
STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+
FDA 510(k)
FDA Class 2
·Clinical Chemistry
M2A-MAGNUM PF CUP 48ODX42ID
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code KWA·December 12, 2018
MATRIX 5.5 GRAPHIC CASE F/POLYAXIAL SCRE
FDA Adverse Event
Malfunction
·SYNTHES JENNERSVILLE·Product code LXH·December 7, 2012
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HLTHCARE CORP·Product code FRN·January 13, 2014
CS BED 9153650455
FDA Adverse Event
Malfunction
·INVACARE CONTINUING CARE·Product code FNL·June 23, 2015
Chest Support for R82 Mustang, Model Numbers: 861810, 861820, 861830; and Rabbit Up, Model Numbers: 869810, 869820, 869830
FDA Recall
Terminated
·Product code ITJ·March 6, 2020
M2A-MAGNUM PF CUP 48ODX42ID
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·November 12, 2018
Chest Support for R82 Mustang, Model Numbers: 861810, 861820, 861830; and Rabbit Up, Model Numbers: 869810, 869820, 869830
FDA Enforcement
Class II
·Terminated·R82 A/S·May 13, 2020
BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020