17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Sientra, inc. Portfinder
FDA 510(k)
FDA Unclassified
·Unknown
KaiBiLi Extended ViralTrans Saline
FDA UDI
Hangzhou Genesis Biodetection & Biocontrol Co., LTD.·16972698600545·5 mL with regular flocked swab
Stryker
FDA UDI
Provision·00810041060563·
Stryker
FDA UDI
Provision·B504OM62211270900·
NA
FDA UDI
STERILMED, INC.·10888551028370·SAW BLADE SAGITTAL SYSTEM 6
Stryker Performance Series
FDA UDI
STRYKER CORPORATION·04546540605689·Stryker Performance Series Sagittal Blade
DEFEND Ear-loop Face Masks
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SIDELAZE LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440NM WAVELENGTH LASERS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ALARIS SMARTSITE
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS S.A DE C.V.·Product code FPA·January 26, 2026
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code FNL·November 3, 2014
URETEX SUP URETHRAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code OTN·May 15, 2013
COULTER LH 750 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·August 23, 2011
9MM/125 DEG TI CANN TFNA 235MM/RIGHT-STERILE
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSB·December 11, 2017
BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code JKA·March 30, 2023
BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code JKA·April 17, 2023
Aquapak 340 SW, 340, mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·July 16, 2014
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