16 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HM70 EVO Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
VITA TITANKERAMIK
FDA UDI
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft·J017B2331120·VITA TITANKERAMIK OPAQUE DENTINE, 1M1, 12 g
Vu a-POD™
FDA UDI
Seaspine Orthopedics Corporation·10889981041830·31x24mm Trial Rasp 12mm 8 deg
WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODELS CFD-347, CFD-347-NS
FDA 510(k)
FDA Class 2
·Orthopedic
Disposable Medical Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523143269·R E-CIMA Vitamin E PS Tibial Insert Sz A 12mm
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523172634·PS Tibia Insert Trial with Posterior Pin Relief...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523144037·R CIMA HXL PS Tibial Insert Sz A 12mm
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523147489·PS Tibia Insert Trial Size A, 12mm - Right
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523145348·R UHMWPE PS Tibial Insert Sz A 12mm
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·September 27, 2023
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 6, 2014
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·July 21, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·July 18, 2013
TRUE METRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH INC·Product code NBW·December 1, 2021
CODMAN Disposable Perforator, 14mm. Cranial perforator.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025