19 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MHD TENS
FDA 510(k)
FDA Class 2
·Neurology
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776365851·Mathieu Retractor, double ended
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780181842·Integra® Jarit® Mathieu Retractor, 6-1/4", Doub...
Bernafon
FDA UDI
Bernafon AG·05711584090251·ZERENA 7 MNR T FW 3.0
DD Bio Splint P
FDA UDI
Dental Direkt GmbH·EDDIK101151·DD Bio Splint P are transparent dental milling ...
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306821950·Buck Ear Curette - #1, Blunt, Straight: 14.5cm/...
SAIPH
FDA UDI
MATORTHO LTD·05055455509788·SAIPH Cemented Patella 42mm
AccuDiag™ Human Growth Hormone (HGH) ELISA
FDA UDI
Diagnostic Automation, Inc.·00850049545815·AccuDiag™ Human Growth Hormone (HGH) ELISA
A co...
RETINA CAMERA TRC-NW7SF MARK II
FDA 510(k)
FDA Class 2
·Ophthalmic
XVI R4.5
FDA 510(k)
FDA Class 2
·Radiology
KIT CONTAINING CC1.P1 AND THE IP1 INTRODUCER
FDA Adverse Event
Injury
·INTEGRA NEUROSCICENCS IMPLANTS SA·Product code GWM·January 28, 2019
SYNCHROMED II
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LKK·March 26, 2010
THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code LPB·October 21, 2014
CENTURY BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·June 11, 2013
LUMAX 540 DR-T
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG.·Product code MRM·June 30, 2011
BD PHASEAL PROTECTOR P53J
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·September 9, 2020
Alinity m System, Part No. 08N53-002
FDA Enforcement
Class II
·Terminated·Abbott Molecular, Inc.·January 12, 2022
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014
HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit) Item Nos: HAA60-09030 HAA60-09040 HAA60-10030 HAA60-10040 HAA60-11030 HAA60-11040 HAA60-11050 HAA60-12040 HAA60-12060 HAA60-13030 HAA60-13040 HAA60-13050 HAA60-13060 HAA60-13070 HAA60-14050 HAA60-14080 HAA60-14090 HAA60-15020 HAA60-15030 HAA60-15040 HAA60-15050 HAA60-15060 HAA60-16030 HAA60-16040 HAA60-16050 HAA60-16070 HAA60-16090 HAA60-17040 HAA60-17060 HAA60-17080 HAA60-18010 HAA60-18030 HAA60-18040 HAA60-18050 HAA60-18060 HAA60-18090 HAA60-20030 HAA60-20040 HAA60-20050 HAA60-20060 HAA60-20080 HAA60-20090 HAA60-22050 HAA60-22060 HAA60-25030 HAA60-25040 HAA60-25050 HAA60-25060 HAA60-30060 HAB60-09030 HAB60-10030 HAB60-10040 HAB60-11040 HAB60-11050 HAB60-12040 HAB60-12060 HAB60-13040 HAB60-13050 HAB60-13060 HAB60-14050 HAB60-15060 HAB60-16070 HAB60-16090 HAB60-17080 HAB60-18010 HAB60-18090 HAB60-20080 HAB60-20090 808200000 Product Usage: These devices are intended for osteosynthesis, external fixation of fractures or bone lengthening procedures.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019