356 results · 24ms · Sources: EU EUDAMED, US FDA

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Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·cobas EGFR MUTATION TEST v2

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·Cobas EGFR MUTATION TEST v2

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·COBAS EGFR MUTATION TEST

N/A

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00681490542432·WRENCH 9150047 TREPHINE DRIVER LOCKING

Oticon

FDA UDI
Oticon A/S·05707131285454·NERA2 PRO, MINIRITE 312 WL TC

Engage Partial Knee System

FDA UDI
Engage UNI LLC·B6951500470000·Mallet

Trial Cage 15deg 12S

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215066567·

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197057721·FLETCHER Sponge Forceps 24cm, ...

P150048

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code LWR·September 23, 2024

P150048

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code LWR·September 26, 2025

CARTIVA

FDA Adverse Event
Injury ·CARTIVA, INC·Product code PNW·July 21, 2020

COBAS® EGFR MUTATION TEST V2 P150044

FDA Adverse Event
Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code OWD·April 1, 2026

COBAS® EGFR MUTATION TEST V2 P150044

FDA Adverse Event
Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code OWD·April 15, 2026

COBAS® EGFR MUTATION TEST V2 P150044

FDA Adverse Event
Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code OWD·March 27, 2025

X-STOP® INTERSPINOUS SPACER

FDA Adverse Event
Injury ·MDT KYPHON SUNNYVALE MFG·Product code NQO·June 6, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 5, 2011

PARADIGM INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LZG·October 7, 2014

TISSUE HEART VALVE

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code LWR·September 11, 2020

Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BT

FDA Enforcement
Class II ·Ongoing·Covidien, LP·April 10, 2024

CARTIVA DEVICE 10MM T20-0329

FDA Adverse Event
Injury ·CARTIVA, INC·Product code PNW·April 23, 2021