13 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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INTERPORE CROSS INTERNATIONAL (ICI) OCCIPITO-CERVICO-THORACIC (OCT) ROD AND PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197151870·CASPAR Scalpel Handle
155mm...
LINK Instruments - Trial implants and size gauges
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575408986·Acetabulum prosthesis trial, reusable - Vario-C...
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710410220480·Anterior Closing Wedge Osteotomy Guide, 22mm x ...
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710420220480·Anterio Lateral Closing Wedge Osteotomy Guide, ...
JBC OPAQUE AND GLITTER
FDA 510(k)
FDA Class 2
·Dental
POWDER FREE NEOPRENE EXAMINATION GLOVES, NON STERILE
FDA 510(k)
FDA Class 1
·General Hospital
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·March 26, 2013
POWER PRO AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code INK·March 10, 2011
HEPARIN
FDA Adverse Event
Malfunction
·Product code NZW·March 31, 2008
Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7302-24
FDA Enforcement
Class II
·Ongoing·ICU Medical Inc.·September 10, 2025
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
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