21 results
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30ms
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Sources: EU EUDAMED, US FDA
GCI Sterilization Wrappers
FDA 510(k)
FDA Class 2
·General Hospital
COE®
FDA UDI
Gc America Inc.·D6582503211·COE® SPACER TRAYS #32D Anterior Perforated-Partial
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780184836·Integra® Jarit® Stille Type Osteotome, 7-3/4", ...
COE®
FDA UDI
Gc America Inc.·10386040012065·COE® SPACER TRAYS #32D Anterior Perforated-Partial
Bradshaw Medical, Inc.
FDA UDI
Bradshaw Medical, Inc.·00810019932458·BIT-HEXALOBE 15 1/4 SQUARE EXTENDED
CHBS
FDA UDI
aap Implantate AG·04042409453984·Tray for implants CHBS 4.5/5.0, empty
Stealth Abutment
FDA UDI
BICON, LLC·00813110021809·5.0 x 4.0mm 0° Stealth Abutment - 2.5mm Post
Scorpio
FDA UDI
Howmedica Osteonics Corp.·07613327029567·Tibial Bearing Insert - PS
ONTRAK TESTCARD 9
FDA 510(k)
FDA Class 2
·Clinical Toxicology
EVOS Lumbar Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·January 9, 2018
ADAPTA DR
FDA Adverse Event
Death
·MEDTRONIC MED REL, INC.·Product code NVZ·September 15, 2011
AC POWER MODULE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·November 6, 2014
SITTER II
FDA Adverse Event
Malfunction
·J. T. POSEY CO.·Product code KMI·July 24, 2013
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·January 18, 2018
VANGUARD COMPLETE KNEE FEMUR RIGHT 60MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·February 27, 2025
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·April 30, 2018
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
GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend PET Gantry 16cm - MEA, Omni Legend PET Gantry 16cm Haifa LM, Omni Legend PET Gantry 16cm Mobile, Omni Legend PET Gantry 21cm - BJ for Global, Omni Legend PET Gantry 21cm - Global Haifa LM, Omni Legend PET Gantry 21cm - Mobile, Omni Legend PET Gantry 21cm WSO LM, Omni Legend PET Gantry 32cm - MEA, Omni Legend PET Gantry 32cm Haifa LM, Omni Legend PET Gantry 32cm Mobile, OMNI PET Gantry 15cm, Omni PET Gantry 15cm - WSO, OMNI PET Gantry 15cm Cardiac- WSO, OMNI PET Gantry 15cm ES - WSO, Omni PET Gantry 15cm Mobile WSO, Omni PET Gantry 21cm - WSO, Omni PET Gantry 21cm Mobile - WSO, OMNI PET Gantry 30cm, Omni PET Gantry 30cm - WSO; System, Tomography, Computed, Emission
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 28, 2026
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013