14 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BACTIDROP (TM) NITRATE B
FDA 510(k)
FDA Class 1
·Microbiology
VARIAX
FDA UDI
Stryker GmbH·04546540540720·Hand Container Lid,Half-Size
PathFinder NXT Minimally Invasive Pedicle Screw System
FDA UDI
Highridge Medical, LLC·03662663161220·Targeting Needle with Luer Lock
MATIRA ANTERIOR CERVICAL SYSTEM
FDA UDI
Kalitec Direct LLC·B07307K0130100·Plate Holder
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0130100·Segmental Rod Reducer Assembly
WARMTOUCH COMPACT WARMING UNIT
FDA Adverse Event
Malfunction
·COVIDIEN/FORMERLY TYCO·Product code DWJ·December 23, 2010
Liebel-Flarsheim IBP Transfer Set
FDA 510(k)
FDA Class 2
·General Hospital
FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR
FDA 510(k)
FDA Class 2
·Physical Medicine
WARM TOUCH II COMPACT WARMING UNIT
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY TYCO HEALTHCARE·Product code DWJ·September 24, 2010
INTELLIS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·March 24, 2026
DAVINCI SI ENDOWRIST GRAPTOR
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC.·Product code NAY·December 27, 2012
SMALLBORE QUADFUSE W/.2 MICRON FILTER IV SET
FDA Adverse Event
Malfunction
·ICU MEDICAL INC.·Product code FPA·November 18, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 14, 2014
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024