13 results
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35ms
·
Sources: EU EUDAMED, US FDA
ENDOTRACHEAL TUBE STYLET
FDA 510(k)
FDA Class 1
·Anesthesiology
Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II
FDA 510(k)
FDA Class 2
·Orthopedic
MULTIPURPOSE HANDLING MEDIUM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
AGC DA2000 KN TIB BRG 71/75X14
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·August 31, 2016
BIOMET AGC V2 INTERLOK TIBIAL 22X 67MM
FDA Adverse Event
Malfunction
·BIOMET ORTHOPEDICS·Product code HRY·June 16, 2017
AGC V2 INTERLOK TIB 10X 71MM
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code HRX·May 19, 2017
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·January 17, 2013
BARD PORT IMPLANTED PORT
FDA Adverse Event
Injury
·CR BARD, INC·Product code LJT·December 1, 2010
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·July 9, 2014
AGC V2 INTERLOK TIB 8 X 75MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·April 12, 2017
AGC V2 INTERLOK TIB 8 X 79MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·March 22, 2016
AGC REVISION KNEE TIBIAL AUGMENTATION
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code JWH·June 28, 2017
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024