23 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF
FDA 510(k)
FDA Class 2
·Radiology
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
GLASIONOMER FX-II
FDA 510(k)
FDA Class 2
·Dental
VICRYL PLUS POLYGLACTIN 910 SUTURE UNKNOWN PROD
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·July 22, 2025
PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code NEW·July 22, 2025
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·November 17, 2008
ASR UNI FEMORAL IMPL SIZE 43
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·September 1, 2011
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 12, 2013
TRUENESS
FDA Adverse Event
Malfunction
·SINOCARE INC·Product code NBW·November 3, 2025
TRUENESS
FDA Adverse Event
Injury
·SINOCARE INC·Product code NBW·October 15, 2025
TRUENESS
FDA Adverse Event
Malfunction
·SINOCARE INC.·Product code NBW·November 28, 2025
TRUENESS
FDA Adverse Event
Injury
·SINOCARE INC ADDRESS LINE 1 NO.265 GUYUAN·Product code NBW·October 20, 2025
TRUENESS
FDA Adverse Event
Malfunction
·SINOCARE INC·Product code NBW·May 29, 2026
TRUENESS
FDA Adverse Event
Malfunction
·SINOCARE INC·Product code NBW·March 11, 2026
TRUENESS AIR
FDA Adverse Event
Malfunction
·SINOCARE INC·Product code NBW·February 26, 2026
Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13. Product Usage: The T2 Tibial Nailing system is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked. The system is indicated for long bone fracture fixation, specifically tibial fracture fixation. The sleeves are intended to ease nail insertion and to protect the condyle surfaces during nail insertion.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·October 22, 2014
TRUENESS
FDA Adverse Event
Malfunction
·SINOCARE INC·Product code NBW·October 20, 2025
TRUENESS
FDA Adverse Event
Malfunction
·SINOCARE INC·Product code NBW·November 19, 2025
TRUENESS
FDA Adverse Event
Malfunction
·SINOCARE INC.·Product code NBW·October 10, 2025
TRUENESS
FDA Adverse Event
Malfunction
·SINOCARE INC·Product code NBW·April 28, 2026