58 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BellaFuse
FDA 510(k)
FDA Class 2
·Orthopedic
HHM
FDA UDI
Oticon A/S·05707131288066·H330V2, DESIGNRITE 10 WL THP HHM
ProLift
FDA UDI
Life Spine, Inc.·00190837117481·
Light Cure Adhesive
FDA UDI
TP ORTHODONTICS INC·00192029000090·ADHESIVE, BRACKET-Tooth Conditioner, Resin
Pro Lift Instruments
FDA UDI
Life Spine, Inc.·00190837031107·
Sklar®
FDA UDI
SKLAR CORPORATION·10649111134173·DISSECTING SCISSORS STR 5"
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100219·LIEBERMAN ASPIRATING SPECULUM K-WIRE
HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX
FDA 510(k)
FDA Class 2
·Hematology
OXIMAX NEOMAX ADHESIVE FOREHEAD REFLECTANCE OXIMETRY SENSOR
FDA 510(k)
FDA Class 2
·Cardiovascular
RADIFOCUS GLIDEWIRE M
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·January 22, 2018
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·April 12, 2024
ACCU-CHEK ® ULTRAFLEX INFUSION SET
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FPA·October 8, 2014
SPRINTER LEGEND RX
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO·Product code LOX·June 7, 2013
ASR 300 SPIKED CUP SIZE 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 30, 2011
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·April 27, 2022
BELLAVISTA
FDA Adverse Event
Malfunction
·IMTMEDICAL AG·Product code CBK·February 18, 2021
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·September 3, 2025
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·September 3, 2025
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·September 3, 2025
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·September 3, 2025