22 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether, NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule and NaviCam Tether
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676221608000·
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676221608070·
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676221608150·
BD BBL™ Port-A-Cul™ Vial
FDA UDI
BECTON, DICKINSON AND COMPANY·30382902216088·BD BBL™ Port-A-Cul™ Vial
Tyber Medical
FDA UDI
Tyber Medical, LLC·M695302P221608S1·PLIF 22mm x 8mm x 16mm x 0 °, PEEK, Sterile
Tyber Medical
FDA UDI
Tyber Medical, LLC·M695502P221608S1·PLIF 22mm x 8mm x 16mm x 0 °, TyPEEK, Sterile
SMITHWICK CAROTID SHUNT
FDA 510(k)
FDA Class 2
·Cardiovascular
VITROS IMMUNODIAGNOSTIC PRODUCTS 25-OH VITAMIN D TOTAL REAGENT PACK, VITAMIN D TOTAL CALIBRATORS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BLACKHAWK Cervical Spacer System
FDA UDI
Choice Spine, LP·00840996164627·BLACKHAWK,STERILE,PARALLEL,16X14X8
CAPTURE-R READY-SCREEN (3)
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·May 10, 2016
PERFORATOR DRIVER W/HUDSON END
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBE·November 3, 2014
4.5MM LCP PROXIMAL FEMUR PLATE 8 HOLES/247MM-LEFT
FDA Adverse Event
Injury
·SYNTHES ELMIRA·Product code HRS·August 19, 2011
QUATTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 9, 2013
DISPENSER, CEMENT
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code KIH·July 14, 2014
DISPENSER, CEMENT
FDA Adverse Event
Injury
·SYNTHES USA·Product code KIH·July 14, 2014
DISPENSER, CEMENT
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code KIH·July 14, 2014
DISPENSER, CEMENT
FDA Adverse Event
Injury
·SYNTHES USA·Product code KIH·July 14, 2014
BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMI·December 20, 2018
CrossCath Support Catheter, RPN CXC3.4-2.2-18-150-P-NS-0, Order Number G51577 For diagnostic and interventional vascular procedures.
FDA Enforcement
Class I
·Terminated·Cook Inc.·December 18, 2019