15 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VU APOD INTERVERTABRAL BODY FUSION DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
X-Box
FDA UDI
INNO Holdings, Inc.·M71180808220·PEEK, Ta
AGILENTCOMPONENT MONITORING SYSTEM, AGILENT 24/26, AGILENT MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE PATIENT MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
AB CARDIETTE START 200 HV
FDA 510(k)
FDA Class 2
·Cardiovascular
EMAX2PLUS
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·October 1, 2015
EMAX 2 MOTOR
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·June 6, 2015
S5 CONSOLE FOR 4 PUMP
FDA Adverse Event
Malfunction
·SORIN GROUP DEUTSCHLAND·Product code DTQ·July 1, 2010
PINNACLE SECTOR II CUP 60MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·September 16, 2015
ANGLED STARDRIVE SCREWDRIVER T8 WITH SLEEVE/SELF-RETAINING
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code OVE·April 26, 2013
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·August 25, 2014
SYSTEM CONSOLE
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·March 20, 2017
ABBOTT TUBE EDTA PLH 13X75 2.0 PNK
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·August 3, 2022
ARCHITECT SIROLIMUS
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code NRP·February 5, 2026
ABBOTT TUBE EDTA PLH 13X75 2.0 PNK
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·September 17, 2019
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018