29 results · 23ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

VALIDATE CHEM 4 CALIBRATION VERIFICATION TEST SET, MODEL 10004

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

Henry Schein

FDA UDI
HENRY SCHEIN, INC.·00304040009000·Zirlux 16+ B2 89x17x22

CORTICAL LOCKING SCREW 3.5mm x 12mm

FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665007565·

Ti-Fix OLIF Spacer

FDA UDI
Tyber Medical, LLC·M695P30121200·Ti-Fix OLIF Spacer 30 x 12 x 12 (mm) x 0 °

CorticaLINK

FDA UDI
LINKSPINE, INC.·00817329022466·CoCr Rod - Curved - 120mm

MODIFICATION TO EXACTECH ACUMATCH INTEGRATED HIP SYSTEM, M-SERIES HIGH OFF-SET NECK SEGMENT, M-SERIES LOW OFF-SET NECK S

FDA 510(k)
FDA Class 2 ·Orthopedic

LIQUICHEK BLOOD GAS CONTROL, MODEL 571, 572, 573

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

VIDAS TOXO IGG II

FDA Adverse Event
Malfunction ·BIOMERIEUX SA·Product code LGD·August 6, 2020

VIDAS TOXO IGG II

FDA Adverse Event
Malfunction ·BIOMERIEUX SA·Product code LGD·August 14, 2020

ARCHITECT CYCLOSPORINE

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES·Product code MKW·May 25, 2012

OCTRODE

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·March 13, 2013

ALTRX NEUT 28IDX50OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LPH·August 15, 2014

ACCU-CHEK FLEXLINK

FDA Adverse Event
Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC·Product code FRN·March 4, 2011

SPRINT QUATTRO SECURE

FDA Adverse Event
Injury ·MPRI·Product code LWS·February 9, 2013

TAXUS¿ ELEMENT¿

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·April 4, 2012

CADD-SOLIS VIP AMBULATORY INFUSION PUMP

FDA Adverse Event
Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FRN·August 8, 2022

CADD-SOLIS VIP AMBULATORY INFUSION PUMP

FDA Adverse Event
Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FRN·August 16, 2022

CADD-SOLIS VIP AMBULATORY INFUSION PUMP

FDA Adverse Event
Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FRN·August 16, 2022

COMPLETE SE ILIAC

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code NIO·November 5, 2014

COMPLETE SE ILIAC

FDA Adverse Event
Death ·MEDTRONIC IRELAND·Product code NIO·November 5, 2014