12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ORAL-B SUB-BRAND MANUAL TOOTHBRUSH
FDA 510(k)
FDA Class 1
·Dental
INFUSION CATHETER EXTENSION SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER
FDA 510(k)
FDA Class 2
·Radiology
SPECTRA WAVEWRITER?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·April 2, 2025
ADVANTAGE SERIES 26 OBS 10/04
FDA Adverse Event
Injury
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·April 23, 2013
DISPOSABLE STRAIGHT INCISOR
FDA Adverse Event
Malfunction
·SMITH & NEPHEW ENDOSCOPY MANSFIELD MANUFACTURE·Product code HAB·April 29, 2011
QUICKSITE LV
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·July 11, 2008
MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·June 10, 2021
MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·May 28, 2022
PROFILE 3D
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·July 30, 2021
MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·July 22, 2021
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