25 results
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21ms
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Sources: EU EUDAMED, US FDA
MONITECT OXYCODONE DRUG SCREEN CASSETTE TEST, MODEL MC 23, FASTECT OXYCODONE DRUG SCREEN DIPSTICK TEST, MODEL MD23
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Asnis
FDA UDI
Stryker GmbH·07613154632688·CANNULATED SCREW
Humelock Reversed Shoulder
FDA UDI
FX SOLUTIONS·03701037306246·HUMELOCK REVERSED REAMER Ø13mm
Discectomy Set
FDA UDI
SPINEOLOGY INC.·M7403030113·8x10mm L 30 degrees Curette w/ Teeth
TiWAVE L Lumbar Cage System
FDA UDI
Kalitec Direct LLC·B07323K0101130·Distractor, Smooth Paddle, Lordotic, 13mm
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0101130·Distractor, Smooth Paddle, 13mm
KSEA SCB-RUI SCO
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PROVEN KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Widex
FDA UDI
Widex A/S·05706069645897·COMPASS GPS V2.2 package (English)
Widex
FDA UDI
Widex A/S·05706069645910·COMPASS GPS V2.2 package (French)
Widex
FDA UDI
Widex A/S·05706069645903·COMPASS GPS V2.2 package (German)
Widex
FDA UDI
Widex A/S·05706069645927·COMPASS GPS V2.2 package (Spanish)
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE DIABETES CARE AG·Product code LZG·April 2, 2013
COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·March 26, 2011
CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code LWR·April 14, 2008
A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant sold under the Medline Industries, Boss Instruments, Millennium Surgical, Medetz Surgical, Surgical Direct, Surgipro, Teleflex Medical, Boss Instruments, Symmetry Surgical, Phoenix Instruments, GICAL, and CareFusion brand names.
FDA Enforcement
Class II
·Terminated·Instrumed International, Inc.·December 17, 2014
BABY CONTROL COSYCOT INFANT WARMER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code FMT·October 24, 2016
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - 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
Convatec Flexi Seal Control Fecal Management System Rx Only REF 411107 Product Usage:For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medications as prescribed by a physician.
FDA Enforcement
Class I
·Terminated·Convatec Inc.·June 25, 2014
PadPro(R) Adult Radiotransparent Multifunction Electrodes, REF/Catalog No. 2001M-C. The PadPro(R) Adult Radiotransparent Multifunction Electrodes with Carbon Leadwires and Medtronic(R) Connector are intended to be used in external pacing, defibrillation and monitoring applications
FDA Enforcement
Class II
·Terminated·ConMed Corporation·May 22, 2013