13 results · 28ms · Sources: EU EUDAMED, 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