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