689 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AMSCO V-PRO 1 AND V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION UNITS
FDA 510(k)
FDA Class 2
·General Hospital
Bernafon
FDA UDI
Bernafon AG·05711584005620·CT7 M, VC PS SF MAC CANTEO 7
SOL-M™ Hypodermic Needle
FDA UDI
Sol-Millennium Medical, Inc.·00818392010701·SOL-M Hypodermic Needle 18G*1
Anterior Clavicle Plate, Medial
FDA UDI
I.T.S. GmbH·09120069811933·Anterior Clavicle Plate, 10-Hole, Left
Meridian
FDA UDI
Seaspine Orthopedics Corporation·10889981265656·Trial, 35mm x 27mm x 18mm, 10 Deg
Meridian
FDA UDI
Seaspine Orthopedics Corporation·10889981246419·Interbody, 35mm x 27mm X 18mm, 10 Deg
Flexitron
FDA UDI
Nucletron B.V.·08717213026568·Flexitron Transfer Tube for Metal Needles (5)
Stablecut®
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024493339·
Sterilizable cap, 25 mm
FDA UDI
Carl Zeiss Meditec AG·04049539103796·
ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING
FDA 510(k)
FDA Class 2
·Orthopedic
3DHJD CAMERA SYSTEM MODEL
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Ascendant
FDA UDI
Choice Spine, LP·10885862260918·
Suprathel®
FDA UDI
Polymedics Innovations GmbH·04260184021338·Suprathel® is an absorbable, microporous membra...
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·May 14, 2013
POLYFLUX LR CAPILLARY DIALYZER
FDA Adverse Event
Malfunction
·GAMBRO DIALYSATOREN GMBH·Product code MSF·August 14, 2008
GORE DUALMESH PLUS BIOMATERIAL
FDA Adverse Event
Injury
·W.L. GORE AND ASSOCIATES·Product code FTL·May 26, 2011
Claviculaplate with Angular Stability, with the below descriptions and associated article numbers. 1. Anterior Clavicle Plate, Medial; Article Numbers: 21116-8, 21117-10, 21118-10. 2. Clavicle Plate; Article Numbers: 21121-6, 21121-8. 3. Clavicle Plate, 3.5mm; Article Numbers: 21122-10, 21122-6, 21122-8. 4. Clavicle Plate, Lateral; Article Numbers: 21123-4, 21124-4, 21127-6, 21128-6.
FDA Enforcement
Class II
·Ongoing·I.T.S. GmbH·April 1, 2026
BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code OOI·September 17, 2025
BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code OOI·September 19, 2025
BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code NJR·April 17, 2026