18 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NavLock Trackers, Robotic Reference Frame
FDA 510(k)
FDA Class 2
·Neurology
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515026742·Doyen Retr, 2 1/4"x 3 1/2 8 1/2"
Ophthalmic Retractor
FDA UDI
KATENA PRODUCTS, INC.·00841668100967·DESMARRES LID RETRACTOR #1
GE VIVID P3 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
GE LIGHTSPEED RT16 / LIGHTSPEED XTRA V2 CT SYSTEM (AKA GE LIGHTSPEED RT16 / LIGHTSPEED XTRA CT SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
UNKN SUSPENSORY FIXATION DEV
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code GAT·September 13, 2021
UNKNOWN MESH PRODUCT (EWHU)
FDA Adverse Event
Injury
·ETHICON·Product code FTL·June 3, 2011
ABBOTT AXSYM SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING, INC.·Product code JJE·October 2, 2008
7.2CM ADJUSTABLE DRILL GUIDE
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·June 21, 2013
IOWA METH DES MOINES IA 1
FDA Adverse Event
Malfunction
·SORIN GROUP USA, INC.·Product code DTZ·June 23, 2011
UNKN SUSPENSORY FIXATION DEV
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code GAT·September 13, 2021
UNKN SUSPENSORY FIXATION DEV
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code GAT·September 13, 2021
UNKN SUSPENSORY FIXATION DEV
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code GAT·September 13, 2021
UNKN SUSPENSORY FIXATION DEV
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code GAT·September 13, 2021
UNKN SUSPENSORY FIXATION DEV
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code GAT·September 13, 2021
UNKN NON-ABSORBABLE SUTURE AND TAPE
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MBI·September 13, 2021
C-FLEX MULTI-LENGTH URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·January 24, 2020
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