12 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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Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-V
FDA 510(k)
FDA Class 2
·Neurology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517569714·CoRoent Ant TLIF Ti, 12x10x34mm 8°
Soniton
FDA UDI
Sbo Hearing A/S·05714464006595·PERSONAL 2.3 FW 1.0.0
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113370·CLEAR CORNEA KNIFE 3.2MM (BX/5)
SCISSORS VANNAS CURVED 3-1/8"
FDA UDI
W.H. Holden, Inc.·D9282203480·
ABBOTT AXSYM ANTI-THYROID-PEROXIDASE, MODELS5F57 COMPRISING STANDARDS/CALIBRATORS
FDA 510(k)
FDA Class 2
·Immunology
Neocis Guidance System (NGS) with Fiducial Array Splint (FAS)
FDA 510(k)
FDA Class 2
·Dental
BD INSTRUMENT MAX CLINICAL
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code OOI·September 21, 2020
SROM KNEE FEM EXT BOW 17X150MM
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code JWH·November 3, 2008
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·August 23, 2011
UNIFY CRT-D
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 11, 2013
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021