13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES
FDA 510(k)
FDA Class 3
·Orthopedic
DIOMED 15 PLUS AND DIOMED 30PLUS LASERS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
REMVIEW SLEEP RECORDER, MODEL 320
FDA 510(k)
FDA Class 2
·Neurology
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 31, 2024
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 31, 2024
OMNIGUIDE BEAMPATH FIBER AND ADAPTER
FDA Adverse Event
OMNIGUIDE, INC.·Product code GEX·October 19, 2010
LAVA C.O.S. POWDER
FDA Adverse Event
Injury
·3M ESPE DENTAL PRODUCTS·Product code NOF·March 16, 2012
WAVEWRITER ALPHA?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 12, 2025
LYNX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 23, 2013
UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·May 2, 2011
ISOFLEX S
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·July 11, 2008
Screw Tap Tapered WP Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.
FDA Enforcement
Class II
·Terminated·Nobel Biocare Usa Llc·February 26, 2020
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012