19 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NuVasive MOD-EX XLIF Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
NA
FDA UDI
Smith & Nephew, Inc.·03596010102560·TWIST DRILL 2.0MM DIA 127.0MM LONG
NA
FDA UDI
STERILMED, INC.·10888551039659·DRILL BIT TWIST STAINLESS STEEL
DOMAIN SURGICAL SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MAXITEX DUPLEX STERILE LATEX POWDERED SURGEON GLOVES WITH PROTEIN LABELING CLAIM (100 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code HSB·July 1, 2014
LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code HSB·June 30, 2014
AFX SYSTEM
FDA Adverse Event
Injury
·ENDOLOGIX, INC.·Product code MIH·October 29, 2014
SPRINTER LEGEND RX BALLOON DILATATION CATHETER
FDA Adverse Event
Injury
·MEDTRONIC TIJUANA·Product code LOX·August 8, 2011
CURRENT ACCEL VR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 8, 2013
LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code HSB·June 30, 2014
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·September 13, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·December 2, 2015
PRESCRIPTIVE OXY PACK - CAPIOX
FDA Adverse Event
Injury
·TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·Product code OEZ·July 27, 2017
ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 2014
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017 S 2000 system 10441730 S 3000 system 10441701 S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015
18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer 10041227 & 10789400 S1000 10441701 S2000 10041461 S2000 (Refurb) - 10440017 S3000 10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017
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