17 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Rapid (6.0)
FDA 510(k)
FDA Class 2
·Radiology
VITA TITANKERAMIK
FDA UDI
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft·J017B2335120·VITA TITANKERAMIK OPAQUE DENTINE, 2M1, 12 g
Symmetry Green
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482060155·Symmetry® Retractor, Green Thyroid, w/Fenestrat...
Vu a-POD™
FDA UDI
Seaspine Orthopedics Corporation·10889981041885·35x27mm Trial Rasp 12mm 8 deg
PROCYON SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HNM Medical
FDA UDI
HNM STAINLESS, LLC.·00842962114193·GREEN THYROID RETRACTOR, 8 1/2", FENESTRATED BL...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523145461·R UHMWPE PS Tibial Insert Sz C 12mm
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523172870·PS Tibia Insert Trial with Posterior Pin Relief...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523147601·PS Tibia Insert Trial Size C, 12mm - Right
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523143382·R E-CIMA Vitamin E PS Tibial Insert Sz C 12mm
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523144150·R CIMA HXL PS Tibial Insert Sz C 12mm
UNICEL DXI 800 ACCESS® IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JLW·September 2, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·November 6, 2014
ACCOLADE TMZF HIP STEM #4
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·July 18, 2013
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·September 12, 2019
Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024