17 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SHERLOCK TLS STYLET, SHERLOCK TLS DETECTOR
FDA 510(k)
FDA Class 2
·General Hospital
Allied Medical LLC
FDA UDI
Allied Medical, LLC·00026072000540·Demand Valve.
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523107919·Straight Rod 6.0mm diameter 240mm CoCr
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523107087·Straight Rod 6.0mm diameter 240mm length Ti6Al4V
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523107674·Straight Rod 6.0mm diameter 240mm length CP Tit...
BIOMET EXTERNAL WRIST PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
ST AIA-PACK CA 19-9
FDA 510(k)
FDA Class 2
·Immunology
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·February 26, 2013
PINN MAR NEUT 32IDX54OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·September 5, 2014
L9000 LIGHTSOURCE
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY SAN JOSE·Product code FCW·April 11, 2011
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT
FDA Adverse Event
Death
·BOSTON SCIENTIFIC CORP.·Product code NIQ·April 17, 2006
TAXUS EXPRESS2 PACLITAXEL ELUTING STENT
FDA Adverse Event
Death
·BOSTON SCIENTIFIC CORPORATION·Product code NIQ·April 17, 2006
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001691;
FDA Enforcement
Class II
·Ongoing·Beaver Visitec International, Inc.·September 4, 2024
KYPHON KURVE BONE FILLER DEVICE 13GA
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO·Product code KIH·July 14, 2020
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT
FDA Adverse Event
Death
·BOSTON SCIENTIFIC CORP.·Product code NIQ·April 17, 2006
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 200 MM, Silicone, Sterile, Item 431197.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015