595 results · 26ms · Sources: EU EUDAMED, US FDA

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SIMPLANT Online Case Review and SIMPLANT Editor

FDA 510(k)
FDA Class 2 ·Radiology

BOSS Instruments

FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515023260·Forester Sponge Fcp, str, 14"

ZEUS-L

FDA UDI
SPINAL ELEMENTS·00840916141875·ZEUS®-L Cobb Elevator Angled Tip 16mm

Symmetry Rochester-Pean

FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482040294·Symmetry® Forceps, Rochester-Pean Hemostatic, C...

Scorpio

FDA UDI
Howmedica Osteonics Corp.·07613154020751·Cruciate Retaining Tibial Insert

THREADED STEINMANN PINS, TROCAR POINT

FDA UDI
Biomet Orthopedics, LLC·00887868016387·

ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ACTIVON TULLE

FDA 510(k)
FDA Unclassified ·Unknown

OT ULTRALINK METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013

INFINITI VISION SYSTEM OZIL

FDA Adverse Event
Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·June 17, 2011

OT PING ENHANCED METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 10, 2014

Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0.021), REF/Product Code RM*ES5F10HAU, STERILE, Rx ONLY

FDA Enforcement
Class II ·Terminated·Terumo Medical Corp·December 20, 2017

Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0.021), REF/Product Code RM*ES6F10HAU, STERILE, Rx ONLY

FDA Enforcement
Class II ·Terminated·Terumo Medical Corp·December 20, 2017

OT ULTRAMINI

FDA Adverse Event
Injury ·LIFESCAN INC.·Product code NBW·December 1, 2010

OT ULTRA EASY METER

FDA Adverse Event
Injury ·LIFESCAN INC.·Product code NBW·January 3, 2012

OT ULTRAMINI

FDA Adverse Event
Injury ·LIFESCAN INC.·Product code NBW·December 7, 2010

OT ULTRA EASY METER

FDA Adverse Event
Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 14, 2012

OT ULTRAMINI METER

FDA Adverse Event
Injury ·LIFESCAN INC.·Product code NBW·June 3, 2011

OT ULTRAMINI METER

FDA Adverse Event
Injury ·LIFESCAN INC.·Product code NBW·May 2, 2011

OT ULTRAMINI METER

FDA Adverse Event
Injury ·LIFESCAN INC.·Product code NBW·May 11, 2011