26 results · 39ms · Sources: EU EUDAMED, 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