8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TBD TENS REUSABLE ELECTRODE
FDA 510(k)
FDA Class 2
·Neurology
FORAMATRON V, MODEL D680
FDA 510(k)
FDA Unclassified
·Unknown
CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
STANDARD IM NAIL
FDA Adverse Event
Injury
·SIGN FRACTURE CARE INTERNATIONAL·Product code HSB·June 19, 2014
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·January 8, 2013
RESTORE ADVANCED RECHARGEABLE
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·November 15, 2010
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 13, 2025
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