12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HERO I DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
NOVO Health Services, LLC
FDA UDI
NOVO HEALTH SERVICES, LLC·00812564034250·X-LG TOUR GOWN PACK (N/S)
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197380898·Super-Cut Stevens Tenotomy Scissors
straig...
COVEREDGE 32
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 20, 2024
REPLENS LONG-LASTING VAGINAL MOISTURIZER (35G TUBE WITH REUSABLE APPLICATOR) MODEL: 83035
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DAUM-LECTRIC MRI DRILLING MACHINE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·May 20, 2013
IDENTITY ADX XL DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC. CRMD·Product code DXY·January 13, 2014
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·June 13, 2011
SROM 9/10 16X11X130 30+4
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·December 13, 2024
SYNFRAME RING CLAMP
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code LXH·March 23, 2018
Stryker 1) XIA Torque Wrench 2) XIA 3 Torque Wrench 3) XIA Elegance Short Torque Wrench Manufactured by: Stryker Spine SAS Z.I. Marticot -33610 -CESTAS -FRANCE +33 (0) 5.57.97.06.30 http://www.stryker.com Distributed in the USA by: Stryker Spine 2 Pearl Court Allendale, NJ 07401-1677 USA +1-201-760-8000 XIA 3 Spinal System- Intended for use in the noncervical spine. When used as an anterior/anterolateral and posterior, non cervical pedicle and on-pedicled fixation system, the XIA 3 Spinal system is intended to provide additional support during fusion autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities; degenerate disc disease (DDD) ; spondylolisthesis; trauma spinal stenosis; curvatures; tumor; pseudoarthrosis and failed previous fusion. XIA - Intended for anterior/anterolateral and posterior, non cervical pedicle and non-pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease; spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis and failed previous fusion.
FDA Enforcement
Class II
·Terminated·Stryker Spine·November 27, 2013