14 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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BOSS Toe Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306804410·Daniel - Robotti Perichondrium Scratcher, 17.5 cm
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319721049·Buck Ear Curette 6-1/2" (16.3cm), size 0, sharp...
DUKE TROCAR
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896097599·DUKE TROCAR WITH SHEATH
Cascade
FDA UDI
CADWELL INDUSTRIES, INC.·00840067100202·Cascade TCS-4
IN-OVATION® L
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807190261101·IN-OVATION® L 018/UL 6&7 10T 0A HK
PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD
FDA 510(k)
FDA Unclassified
·Unknown
PORTEX TUOHY EPIDURAL NEEDLE 17G, PORTEX TUOHY EPIDURAL NEEDLE 18G
FDA 510(k)
FDA Class 2
·Anesthesiology
K-WIRE, RECON 3.2X400 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·June 29, 2011
HYPE SCL 4 LATERALIZED CEMENTLESS STEM
FDA Adverse Event
Injury
·S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION·Product code LZO·January 17, 2025
PICC LINE
FDA Adverse Event
Injury
·BARD·Product code LJS·October 13, 2014
6000CMS
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·June 10, 2013
SETROX S 60
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVZ·July 19, 2011
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012