12 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VASCUTEK GELSOFT PLUS VASCULAR GRAFT
FDA 510(k)
FDA Class 2
·Cardiovascular
BASE
FDA UDI
Nuvasive, Inc.·00887517701817·BASE HL Trial, 12x38x28mm 30°
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690191957·Revision Knee Reamer Spiral Fluted - Zimmer 23mm
Ophthalmic Forceps
FDA UDI
KATENA PRODUCTS, INC.·00841668111338·TYING FORCEPS CURVED ROUND TITANIUM
3M™ Victory Series™
FDA UDI
3M UNITEK CORPORATION·00652221118257·3M™ Victory Series™ Second Molar Bands, 955-230...
Zuma™
FDA UDI
Seaspine Orthopedics Corporation·10889981060565·Trial, 32mm x 25mm x 14mm, 12 Deg
H WAVE MUSCLE STIMULATOR
FDA 510(k)
FDA Class 2
·Physical Medicine
ELECTRO-NEVE STIMULATOR TENS MODEL BIOMED PLUS/A
FDA 510(k)
FDA Class 2
·Neurology
REVEAL XT
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code DSI·February 11, 2013
CURRENT PLUS DR, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·January 10, 2011
XMAX MOTOR
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code ERL·December 13, 2013
Roadrunner Uniglide Hydrophilic Wire Guide, Catalog Numbers and GPN: HPWA-18-260, G30489; HPWA-18-320, G30490; HPWA-25-260, G30491; HPWA-35-260, G30492; HPWAS-35-260, G30506; HPW-35-150, G56149; HPW-35-180, G56150; HPWS-35-150, G56152; HPWS-35-180, G56153; HPWA-35-80, G56172; HPWA-35-150, G56173; HPWA-35-180, G56174; HPWA-18-180, G56160; HPWAS-35-150, G56176; HPWAS-35-180, G56177. Used with vascular catheter. Roadrunner UniGlide Hydrophilic Wire Guide is constructed from a steerable, metallic core with a polymer coating. A hydrophilic coating is applied over the radiopaque polymer jacket. Sterile- Individual product is packaged in a Tyvek-film sterilizable outer pouch and boxed in a quantity of five.
FDA Enforcement
Class I
·Terminated·Cook Inc.·August 31, 2016