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