12 results
·
20ms
·
Sources: EU EUDAMED, US FDA
PLANMED NUANCE DIGIGUIDE
FDA 510(k)
FDA Class 2
·Radiology
BD¿ INSULIN SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMI·March 4, 2019
SYRINGE 0.3ML 30GA 8MM 10BAG 500 PL/WG
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMI·June 5, 2020
BRIDGEPOINT MEDICAL MANTARAY(TM) CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
BIOSORB RESORBABLE VOID FILLER
FDA 510(k)
FDA Class 2
·Orthopedic
GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 3 / 12 MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·July 3, 2019
GMK FIXED CEMENTED TIBIAL BASE PLATE RIGHT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code JWH·January 14, 2015
SLEEK OTW PTA CATHETER
FDA Adverse Event
Injury
·CLEAR STREAM TECHNOLOGIES, LTD.·Product code LIT·May 16, 2013
LIFEPAK EXPRESS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·August 13, 2008
MBT CEM KEEL TIB TRAY SZ2.5
FDA Adverse Event
Injury
·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code NJL·June 9, 2011
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020