21 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HUESTIS FLEXI-BOARD
FDA 510(k)
FDA Class 2
·Radiology
TRU Straight Abutment RP 1.5mm cuff - Titanium
FDA UDI
STERNGOLD DENTAL LLC·00841549110153·TRU Straight Abutment RP 1.5mm cuff - Titanium....
OsteoVation
FDA UDI
SKELETAL KINETICS LLC·00813845020139·OsteoVation QWIK Inject Bone Void Filler
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690184256·Rosen Double Ended Army Navy Z retractor
Clamp Chalazion Small
FDA UDI
BLINK MEDICAL LIMITED·05060480408081·
Symmetry Surgical
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482129678·Symmetry® Electrode; Monopolar J Hook; w/Valve;...
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515230408·Leivers Vent Tube Int. Forceps, 5 1/4"
MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (CURRENT), MENTOR CONTOUR GENESIS SYSTEM (PROPOSED)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FORA G31A/TD-4256A BLOOD GLUCOSE MONITORING SYSTEM AND FORA G31B/TD-4256B BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
UNICOMPARTMENTAL KNEE COMPONENT
FDA Adverse Event
Injury
·ALEXANDRIA RESEARCH TECHNOLOGIES, INC.·Product code HSX·August 28, 2012
TGS UKA FEMORAL AND TIBIAL COMPONENTS
FDA Adverse Event
Injury
·ALEXANDRIA RESEARCH TECHNOLOGIES, LLC·Product code HSX·April 21, 2011
TGS UKA FEMORAL AND TIBIAL COMPONENTS
FDA Adverse Event
Injury
·ALEXANDRIA RESEARCH TECHNOLOGIES, LLC·Product code HSX·April 1, 2011
UNICEL® DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JGS·November 20, 2010
ARTICULEZE M HEAD 36MM +5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910 ·Product code JDI·January 9, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 1, 2014
BD ECLIPSE NEEDLE WITH SMARTSLIP TECHNOLOGY
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·January 29, 2020
Nuclear Gamma Cameras (ADAC Vertex Classic, ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60) Philips Medical Systems, Cleveland, OH
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·May 20, 2015
OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Console 2i REF 450-0005-01 -Power Control Console 2i REF ECOS-450-0005-00 OsteoMed Footswitches: -OsteoMed BMF Footswitch REF 450-0390 -D-Bi-Directional Master Footswitch REF 450-0380 -D-Uni-Directional Footswitch II REF 450-0350 -D-Bi-Directional Footswitch II REF 450-0360 -D-Uni-Directional Master Footswitch REF 450-0370
FDA Enforcement
Class II
·Ongoing·Osteomed, LLC·December 15, 2021
Nuclear gamma cameras (ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60 & ADAC CARDIO C60) Nuclear gamma cameras intended to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·May 20, 2015
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024