14 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Dental Glass Ceramics Blocks
FDA 510(k)
FDA Class 2
·Dental
Edge™ Diamond FP023-5EF Football Pointed
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172003230·Diamond dental bur, reusable
DISCOVERY NM 750B
FDA 510(k)
FDA Class 1
·Radiology
GEBDI TRIBOS 501
FDA 510(k)
FDA Class 2
·Dental
TPRLOC COCR CMTD STM T1 12.5MM
FDA Adverse Event
Death
·BIOMET UK LTD.·Product code JDI·March 23, 2026
CMK MOD 12/14 SZ202 L130
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code LZO·November 24, 2025
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 22, 2014
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 20, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011
REVITAN, DISTAL PART, CURVED, UNCEMENTED, 24/200
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code KWY·July 20, 2023
URETERAL BRUSH BIOPSY SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FDX·November 15, 2023
CMK MOD 12/14 SZ202 L130
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·January 8, 2026
URETERAL BRUSH BIOPSY SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FDX·January 7, 2022
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