10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CULUTURE SET CHLAMYDIA ISOLATION AND
FDA 510(k)
FDA Class 1
·Microbiology
MONDEAL
FDA UDI
MONDEAL Medical Systems GmbH·04050435062285·MCD Screw 3.0 x 42 mm cannulated M2
partia...
iNSitu Hip System
FDA UDI
NEXTSTEP ARTHROPEDIX, LLC·00816127025792·Acetabular Reamer, Full Hemisphere, Crossbar, 42mm
LUMENIS FAMILY OF IPL SYSTEMS AND COMBINATION IPL/ND:YAG SYSTEMS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SAUFLON CLARITI (SOMOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER
FDA 510(k)
FDA Class 2
·Ophthalmic
VALIANT THORACIC STENT GRAFT SYSTEM
FDA Adverse Event
Death
·MEDTRONIC IRELAND·Product code MIH·November 13, 2012
HARMONIC ACE 23 CM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code LFL·January 2, 2008
CAPSURE SP
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2015
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x45 mm Catalog Number: 18965045S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015