26 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard
FDA 510(k)
FDA Class 2
·Radiology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517576446·CoRoent Ant TLIF Ti, 9x13x36mm 0°
Contrast Line
FDA UDI
ARGON MEDICAL DEVICES, INC.·00886333207442·Contrast Line 30"(75cm) M/F (Braided) 1200 PSI
OPTETRAK LOGIC TOTAL KNEE SYSTEM TRAPEZOIDAL TIBIAL TRAY, SIZES 2.5F/1.5T-3.5F/4.5T
FDA 510(k)
FDA Class 2
·Orthopedic
DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
INTELLAMAP ORION?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DRF·May 12, 2026
INTELLAMAP ORION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code DRF·April 15, 2025
PS TIBIAL INSERTS SZ 5, 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·April 24, 2024
INTELLAMAP ORION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code DRF·April 29, 2026
INTELLAMAP ORION?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DRF·April 17, 2026
LOGIC FEMORAL PS CEM LEFT SZ 2.5
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·December 27, 2024
AUTOMATIC ENDOSCOPE REPROCESSOR
FDA Adverse Event
Malfunction
·MINNTECH CORPORATION·Product code FEB·October 7, 2008
CORAIL2 NON COL HO SIZE 13
FDA Adverse Event
Injury
·3003895575 DEPUY FRANCE·Product code KWA·June 27, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·July 29, 2011
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·October 22, 2024
bvi Beaver Xstar Safety Crescent, 2.5mm, 55o Bevel Up, REF 378234 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.
FDA Enforcement
Class II
·Terminated·Beaver-Visitec International Inc.·February 7, 2018
INTELLAMAP ORION?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code DRF·January 30, 2026
LGC TIBIAL FIT TRAY CEM SZ 3.5F / 2.5T
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·December 11, 2024
INTELLAMAP ORION?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DRF·April 1, 2026
INTELLAMAP ORION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code DRF·November 21, 2024