18 results
·
33ms
·
Sources: EU EUDAMED, US FDA
HIGH FLOW ADJUSTABLE ENTRAINMENT NEBULIZER
FDA 510(k)
FDA Class 2
·Anesthesiology
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690128625·Revision Fluted Offset Stem 10mm x 150mm x 4mm
MODEL 3100-64: QUADRATURE SPINE COIL
FDA 510(k)
FDA Class 2
·Radiology
ANGIOMED SKIN FASCIA KNIFE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BONE SCR 6.5X30 SELF-TAP
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING B.V.·Product code MRA·May 28, 2019
ECHO B-MTRC MP RP SO 8
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·May 28, 2019
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·February 11, 2013
RIATA ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 10, 2011
TPS MICRO DRIVER
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code DZJ·July 24, 2014
CER BIOLOXD OPTION HD 36MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·May 30, 2019
BONE SCR 6.5X30 SELF-TAP
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING B.V.·Product code MRA·May 28, 2019
UNKNOWN LINER
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HTW·May 28, 2019
G7 PPS LTD ACET SHELL 50D
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·May 28, 2019
ECHO B-MTRC MP RP SO 8
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·May 28, 2019
CER BIOLOXD OPTION HD 36MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·May 29, 2019
G7 HI-WALL ARCOMXL LNR 36MM D
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·May 28, 2019
TFNA HELICAL BLADE 85MM STERILE
FDA Adverse Event
Injury
·SYNTHES ELMIRA·Product code HSB·July 21, 2016
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021