26 results
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39ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device
FDA 510(k)
FDA Class 2
·Orthopedic
Orthos
FDA UDI
ORMCO CORPORATION·00889989030150·ORTHOS CM SST ARCH 18 DIA LOLG PK10
IN-OVATION® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K191551811·IN-OVATION® mini EURO 018/5-5 CS HK
IN-OVATION® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K191551821·IN-OVATION® mini EURO 018/5-5 CBC HK
SUPRA 577.Y LASER
FDA 510(k)
FDA Class 2
·Ophthalmic
INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM WITH DA VINCI CONNECT & DA VINCI ONSITE, MODEL IS2000
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
COBAS INTEGRA 800
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·October 1, 2008
CONVECTIVE PATIENT WARMER
FDA Adverse Event
Malfunction
·STRYKER CORP DBA GAYMAR·Product code DWJ·July 1, 2011
ADVIA CENTAUR XP CA 19-9 ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code NIG·June 26, 2013
BD PCR CARTRIDGE
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·May 1, 2025
BD PCR CARTRIDGE
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·January 17, 2025
BD PCR CARTRIDGE
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·January 17, 2025
BD PCR CARTRIDGE
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·January 17, 2025
BD PCR CARTRIDGE
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·January 17, 2025
BD PCR CARTRIDGE
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·January 17, 2025
BD PCR CARTRIDGE
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·January 17, 2025
BD PCR CARTRIDGE
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·January 17, 2025
BD PCR CARTRIDGE
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·January 17, 2025
BD PCR Cartridges used with MAX System. Model Number: 437519
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·January 29, 2025
MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225 (Suction Coagulator, Handswitching, 8 Fr, 6 inch (15.24cm), Product Code 004325 (Suction Coagulator, Handswitching, 12 Fr, 6 inch (15.24cm)), and Product Code 0041BN (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm), Bulk Non Sterile)
FDA Enforcement
Class II
·Ongoing·Megadyne Medical Products, Inc.·August 9, 2023