12 results
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23ms
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Sources: EU EUDAMED, US FDA
DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100, DADE PFA COLLEGEN/EPINEPHRINE TEST CARTRIDE, DADE PFA COLLEAGEN /ADP
FDA 510(k)
FDA Class 2
·Hematology
Custom Procedure Kit
FDA UDI
MEDIVATORS INC.·40677964020429·The ENDO CARRY-ON Procedure Kit contains all of...
VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DRX HBA1C - FOR PRESCRIPTION HOME USE
FDA 510(k)
FDA Class 2
·Hematology
XIA SCREW 6, 5 X 40
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code MNI·May 11, 2011
NA
FDA UDI
Zimmer, Inc.·00889024065116·
INTERSTIM II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code EZW·March 13, 2013
ASR UNI FEMORAL IMPL SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD·Product code KWA·February 16, 2011
IMPLANTIUM
FDA Adverse Event
Other
·DENTIUM CO., LTD.·Product code DZE·February 22, 2008
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024