27 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113462·SCLEROTOME BLADE #57 (BX/5)
Drill
FDA UDI
Treace Medical Concepts, Inc.·00810111227162·Drill
ACUMED
FDA UDI
Acumed LLC·10806378014208·3.5mm x 30.0mm Locking Cortical Screw
ACUMED
FDA UDI
Acumed LLC·10806378014215·3.5mm x 30.0mm Locking Cortical Screw
AXIAMED TRANS-SACRAL SPINAL ACCESS DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES
FDA 510(k)
FDA Class 1
·Ophthalmic
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO INC·Product code GJS·October 26, 2010
PLATE, FIXATION, BONE
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HRS·March 27, 2015
PLATE,FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HRS·March 26, 2015
SCREW,FIXATION, BONE
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HWC·March 27, 2015
INRATIO
FDA Adverse Event
Other
·ALERE SAN DIEGO, INC.·Product code GJS·October 26, 2010
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDI·October 24, 2014
PRECISION®
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 1, 2013
INRatio 2 Monitors - 0200431 Alere INRatio 2 PT/INR Professional Testing System - 0200432 Alere INRatio 2 PT/INR Home Monitoring System - 0200433 Alere INRatio 2 PT/INR Home Monitoring System - 0200457 Alere INRatio 2 Replacement Monitor - 55112 Alere INRatio 2 Replacement Monitor - 55131 Alere INRatio 2 Replacement Monitor - 55128A Alere INRatio 2 PT/INR Professional Monitoring System The test systems contain individually packaged components needed to use the product, such as a monitor, user guide, quick reference guide training DVD or CD, Lancets (home monitoring kits contain an Autolet, Unilet, gauze pads, and alcohol wipes), power supply (home monitoring kits contain AA batteries), results log book and a warranty card. None of the components, except for the lancets, are sterile. Intended for in vitro diagnostic use for quantitative determination of international normalized ratio (INR) in fresh capillary whole blood to monitor the effect of warfarin on clotting time by health care professionals and home users.
FDA Enforcement
Class I
·Terminated·Alere San Diego, Inc.·January 14, 2015
SCREW,FIXATION, BONE
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HWC·March 27, 2015
SCREW,FIXATION, SCREW
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·March 26, 2015
PLATE, FIXATION, BONE
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HRS·March 27, 2015
SCREW, FIXATION, SCREW
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HWC·March 27, 2015