13 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ULTRASKIN HYDROPHILIC GUIDE WIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221037886·Unitek(TM) Bicuspid Band General Purpose Wide U...
HAcancellous™ PEEK-C
FDA UDI
INNO Holdings, Inc.·M711591417070·HAcancellous PEEK-C, 14L x 17W x 7H x 8°, HA PE...
Cadet Cervical Cage
FDA UDI
VALORUS SPINE LLC·00811771033667·Cadet Cervical Cage, 14mm x 17mm x 07mm, Non-Lo...
Cadet Cervical Cage
FDA UDI
VALORUS SPINE LLC·00811771034299·Cadet Cervical Cage, 14mm x 17mm x 07mm, 7° Lor...
K2M General Instruments
FDA UDI
VB Spine LLC·10888857583139·Modular Trial 22x8x12mm, 7°
CERCON CERAM EXPRESS CERAMIC SYSTEM
FDA 510(k)
FDA Class 2
·Dental
FULACCESS MODEL 1.0
FDA 510(k)
FDA Class 2
·Radiology
VERSAFITCUP CC LINER
FDA Adverse Event
Injury
·Product code LZO·October 23, 2014
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 4, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code FPB·June 27, 2011
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024