31 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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VACCESS PTA DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16741118500·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674111850060·
CARDINAL HEALTH
FDA UDI
Cardinal Health 200, LLC·10885380077357·1.1mm Non-Threaded Guide Wire 150mm
Vilex Power Accessory
FDA UDI
VILEX IN TENNESSEE, INC.·00841731122223·KWire .045x6" (1.1x150mm)
Flexitron
FDA UDI
Nucletron B.V.·08717213022362·Flexitron Transfer Tube Set for 4F Flexibles (1...
Vilex Power Accessory
FDA UDI
VILEX IN TENNESSEE, INC.·00841731122216·KWire .045x6" (1.1x150mm) Threaded
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587C11185040·11mm H x 18mm W x 50mm L x 4 degree XLIF Corona...
ONTRAK TESTCUP 5 M2K, CAT. 11 1850 1
FDA 510(k)
FDA Unclassified
·Unknown
K-PACK II NEEDLE- 27G & 30G THIN WALL
FDA 510(k)
FDA Class 2
·General Hospital
SPACELABS BLEASESIRIUS ANESTHESIA WORKSTATION
FDA 510(k)
FDA Class 2
·Anesthesiology
LONG NAIL KIT R2.0, TI, RIGHT GAMMA3 Ø11X380MM X 125°
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS-KIEL·Product code HSB·April 12, 2013
SENTINOL SELF-EXPANDING NITINOL BILIARY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·March 30, 2007
STYLE 68 SALINE FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FWM·September 11, 2017
GUARDIAN ROLLING WALKER
FDA Adverse Event
Malfunction
·A & E·Product code ITJ·November 4, 2008
ASR ACETABULAR CUPS 48
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·May 14, 2013
CIDEX OPA SOLUTION
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code MED·August 13, 2008
Dural Graft Matrix DuraGen¿ Dural Graft Matrix is an absorbable implant for repair of dural defects. DuraGen matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGen matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes..
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corporation·May 22, 2013
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;
FDA Recall
Open, Classified
·Mozarc Medical US LLC·Product code NIE·October 17, 2025
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 16 cm;
FDA Recall
Open, Classified
·Mozarc Medical US LLC·Product code NIE·October 17, 2025