18 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Citric Complete Dry Citric Acid (45X)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704294071·
NA
FDA UDI
KEY SURGICAL, INC.·10849771050145·Steinmann Pins, Double trocar threaded, 5/64-in...
Sklar®
FDA UDI
SKLAR CORPORATION·10649111210495·HALSTED MOSQ FCP CVD 1X2 5"
SOLID CANCELLOUS LAG SCREW
FDA UDI
Biomet Orthopedics, LLC·00887868005190·
Ophthalmic Ring
FDA UDI
KATENA PRODUCTS, INC.·00841668100769·FLIERINGA FIXATION RING 15MM
OsteoMed
FDA UDI
OSTEOMED LLC·00845694045872·PrimaLIF LLIF PEEK Implant, 17mm X 26mm X 50mm,...
EXTRA PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE; PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE
FDA 510(k)
FDA Class 2
·Cardiovascular
RPC E-Z CHEK 6.8-8.5 PH TEST STRIPS, MODEL K100-0117 AND E-Z CHEK 0-14 PH TEST STRIPS, MODEL K100-0104
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TROCHANTERIC NAIL KIT, TI GAMMA3 10X170MM X 125
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·September 14, 2012
ACCU-CHEK ® MOBILE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·October 15, 2014
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·COCHLEAR LTD.·Product code MCM·June 17, 2013
TRANSEND¿ EX
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - COSTA RICA·Product code DQX·July 22, 2011
M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·October 4, 2024
PEDICLE SCREW MUST COMBINED SETSCREW H4-T27 - (4X)
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code NKB·October 9, 2019
PUMP MMT-1880L MM770G BLE MG
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·October 16, 2023
PEDICLE SCREW 6X45
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code KWP·July 5, 2019
Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021