21 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GE LIGHTSPEED ACT FP16
FDA 510(k)
FDA Class 2
·Radiology
TOTAL HIP FEMORAL HEAD - 12/14 TAPER
FDA 510(k)
FDA Class 2
·Orthopedic
ACON AMP ONE STEP AMPHETAMINE TEST STRIP, ACON AMP ONE STEP AMPHETAMINE TEST DEVICE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
PANORAMA CENTRAL STATION
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC·Product code MHX·April 30, 2013
NATURALYTE
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·August 21, 2014
TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·April 29, 2011
ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATIN
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code DQX·April 23, 2012
METASUL LDH, HEAD, 56, CODE V, TAPER 18/20
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·April 27, 2018
METASUL LDH, HEAD, 56, CODE V, TAPER 18/20
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWY·January 31, 2018
METASUL LDH, HEAD, 40, CODE F, TAPER 18/20
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·June 13, 2018
METASUL LDH, HEAD, 44, CODE J, TAPER 18/20
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KXA·October 24, 2017
METASUL HEAD 28MM L 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·August 7, 2018
METASUL HEAD 28MM L 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·August 3, 2018
METASUL, HEAD, M, 32/0, TAPER 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·March 12, 2018
METASUL LDH, HEAD, 44, CODE J, TAPER 18/20
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·February 22, 2018
ECHO BI-MTRC MICR RP SO 5X73
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·June 6, 2018
METASUL LDH, HEAD, 44, CODE J, TAPER 18/20
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·June 14, 2018
METASUL LDH, HEAD, 48, CODE N, TAPER 18/20
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·May 18, 2018
Natrelle 133 Series Tissue Expanders Product Usage: Natrelle 133 Series Tissue Expander is intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed.
FDA Enforcement
Class II
·Terminated·Allergan Inc·July 29, 2015
Torque Limiting Screwdriver: Greatbatch Medical, Torque Limiting Driver, Non Sterile, Rx Only. PRECIMED, Non Sterile. Zimmer, Non Sterile, Rx Only. Screwdriver: Customer Number/Model: 804-03-038 T11623, T14001 T14001, MTO35173507 T14378, MTO375173506 T14379, MTO35173505 T14380, MTO35175303 T8127.
FDA Enforcement
Class II
·Terminated·Greatbatch Medical·June 8, 2016