16 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BUPRENORPHINE ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS FOR BECKMAN COULTER SYNCHRON SYSTEMS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Stamey
FDA UDI
COOK INCORPORATED·00827002155350·Stamey Percutaneous Suprapubic Catheter Set
CARDINAL HEALTH
FDA UDI
Cardinal Health 200, LLC·10885380076275·0.8mm Guide Wire 100mm
FIBONACCI™ PROXIMAL LATERAL TIBIA PLATE, LEFT, 8 HOLE
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665035209·
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0310080·Probe, 1.5 inch Ball, Lenke, Thoracic, Straight...
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0840080·Distractor, Screw to Screw
ADVANCED ORTHOPAEDIC SOLUTIONS TROCHANTERIC NAIL
FDA 510(k)
FDA Class 2
·Orthopedic
TEMPTELLER INFRARED EAR THERMOMETER, MODELS TT-901, TT-911 AND TT-921
FDA 510(k)
FDA Class 2
·General Hospital
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·November 5, 2014
ATLANTIS® ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWQ·July 12, 2017
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWQ·May 2, 2017
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR PURITAN·Product code CBK·April 24, 2013
HEARTSINE SAMARITAN 300P AND PAD PAK
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES, LTD, CANBERRA HOUSE·Product code MKJ·August 11, 2014
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·April 14, 2011
PROSTHESIS, RIB REPLACEMENT
FDA Adverse Event
Injury
·SYNTHES USA·Product code MDI·March 13, 2015
AperFix Femoral Implant Coring Removal Drill, labeled as the following: a. Femoral Removal Coring Reamer 9mm, Model Number CM-7109; b. Femoral Removal Coring Reamer 10mm, Model Number CM-7110; c. Femoral Removal Coring Reamer 11mm, Model Number CM-7111; d. Femoral Removal Coring Reamer 9 mm - Long, Model Number CM-7129; e. Femoral Removal Coring Reamer 10 mm - Long, Model Number CM-7130; f. Femoral Removal Coring Reamer 11 mm - Long, Model Number CM-7131; Orthopedic surgical instrument.
FDA Enforcement
Class II
·Terminated·Cayenne Medical Inc.·August 1, 2018