27 results
·
18ms
·
Sources: EU EUDAMED, US FDA
WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/AEROSET
FDA 510(k)
FDA Class 2
·Immunology
Custom Procedure Kit
FDA UDI
MEDIVATORS INC.·40677964016378·Endo Carry-On Procedure Kit
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169328679·TEMPLATE 3001931 ZEVO 31MM 1 LVL
SCANLAN® Easy-Tag™ Tracking System
FDA UDI
SCANLAN INTERNATIONAL INC·00846159033038·Easy-Tag Pre-Printed, Endo - HLD, Green 250/Spl
LIFEPAK® 15 monitor/defibrillator
FDA UDI
PHYSIO-CONTROL, INC.·00883873872086·15AACAABAABBAAAAAAAAAAAFLP15 MONITOR/DEFIB
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL UM-D·Product code FPA·March 30, 2026
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL UM-D·Product code FPA·March 30, 2026
URANUS, COMFORTOUCH LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AU5 ULTRASOUND IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
SUMMIT POR TAPER SZ6 STD OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDIC INC, 1818910·Product code LPH·June 21, 2018
ETI-AB-AUK PLUS kits,REF P001931, DiaSorin S.p.A., 13040 Saluggia (VC), Italy, Distributed by: DiaSorin Inc., 1951 Northwestern Avenue, P.O. Box 285, Stillwater, MN 55082-0285 In vitro enzyme immunoassay (EIA) intended for use in the qualitative detection of antibodies to hepatitis B surface antigen (anti-HBs) in human serum or plasma.
FDA Recall
Terminated
·Diasorin Inc.·Product code LOM·August 19, 2010
KIT CONTAINING CC1.P1 AND THE IP2 INTRODUCER
FDA Adverse Event
Malfunction
·GMS - GESELLSCHAFT FUR MEDIZINISCHE SONDENTECHNIK - N·Product code GWM·March 11, 2013
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NTE·February 27, 2011
DEXTRUS 4136
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO·Product code DTB·February 15, 2008
SUMMIT POR TAPER SZ4 HI OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDIC INC, 1818910·Product code LPH·June 20, 2018
SUMMIT POR TAPER SZ6 HI OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDIC INC, 1818910·Product code LPH·June 1, 2018
METRX SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code HRX·June 10, 2024
SUMMIT POR TAPER SZ4 HI OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·September 28, 2018
SUMMIT POR TAPER SZ7 HI OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·October 18, 2019
SUMMIT POR TAPER SZ4 HI OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. - 8010379·Product code LPH·July 1, 2015