84 results · 30ms · Sources: EU EUDAMED, US FDA

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Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT REALTIME CMV

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval
FDA Class 2 ·RealTime CMV Assay

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval
FDA Class 2 ·Abbott RealTime CMV Amplification Kit (09N21-090), Abbott RealTime CMV Control Kit (09N21-080), Abbott RealTime CMV Cali

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval
FDA Class 2 ·Abbott Real Time CMV Amplification Reagent Kit / CMV Control Kit / CMV Calibrator Kit.

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval
FDA Class 2 ·Abbott RealTime CMV

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval
FDA Class 2 ·Abbott RealTime CMV

OsteoMed

FDA UDI
OSTEOMED LLC·00845694035828·13mm Tissue Elevator

VIVID POST TRANSLUCENT

FDA UDI
BIOLOREN SRL·08056099233210·Conical fiberglass light transmitting posts ø 1...

NON-STERILE Biopsy Valve Covers

FDA UDI
Batrik Medical Manufacturing Inc·00690521020689·Biopsy Valve Cover - Pentax - Pink

Batrik Couvrette Valve Covers - Pink

FDA UDI
Batrik Medical Manufacturing Inc·00690521015845·Biopsy Valve Cover - Pentax - Pink

Hayden Medical

FDA UDI
Hayden Medical, Inc.·00840319705247·Mayo-Hegar Needle Holder 6-1/4" (15.6cm), serra...

Image1 SPIES System

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

GORE TIGRIS® VASCULAR STENT

FDA Adverse Event
Injury ·W.L. GORE & ASSOCIATES·Product code NIP·October 11, 2016

RESOLUTE ONYX RX

FDA Adverse Event
Malfunction ·MEDTRONIC IRELAND·Product code NIQ·January 31, 2019

Somatic Gene Mutation Detection System

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

Drug-Eluting Sinus Stent

FDA Pre-Market Approval
FDA Class 3 ·PROPEL

RESOLUTE INTEGRITY RX

FDA Adverse Event
Malfunction ·MEDTRONIC IRELAND·Product code NIQ·April 9, 2019

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