10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ABX ERYTROL
FDA 510(k)
FDA Class 2
·Hematology
Manus Medical, LLC
FDA UDI
Manus Medical, LLC·00811870037955·STEREO PACK W/CHLORAPREP
QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
UNKNOWN SCREW
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWY·October 11, 2018
BD¿ GENERAL USE STERILE HYPODERMIC NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·October 4, 2018
GYNECARE GYNEMESH* PS
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTO·April 10, 2013
ATTAIN STARFIX
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 12, 2011
DURATA STS OPTIM
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 27, 2008
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015