18 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EDGELOCK
FDA 510(k)
FDA Class 2
·Orthopedic
DAR
FDA UDI
Covidien LP·10884521784628·Pediatric Breathing Circuit with Exhalation Val...
DAR
FDA UDI
Covidien LP·20884521069395·Pediatric Breathing Circuit with Exhalation Val...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702391572·Elvarex 4/Thigh High/Slant-Open Toe/Dotted 5 c...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702502527·Elvarex 3/Knee High/Profile-Slant-Open Toe-Elep...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702358056·Elvarex 2/Knee High/Open Toe-Elephantiasis-Vers...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702429435·E1/AG/SL-CT/NOP5-T-OH-ZI/BR
KIT BDMAX SARS-COV-2 REAGENTS
FDA Adverse Event
Injury
·BECTON, DICKINSON & CO.·Product code QJR·May 13, 2020
X-STATIC SILVERSEAL HYDROCOLLOID FILM AND ISLAND DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
HD CAMERA HEAD
FDA Adverse Event
Malfunction
·SHIRAKAWA OLYMPUS CO., LTD.·Product code FET·January 12, 2026
LUX 1440
FDA Adverse Event
Malfunction
·PALOMAR MEDICAL TECHNOLOGIES, INC.·Product code GEX·May 5, 2012
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·July 2, 2019
MITEK BIOKNOTLESS RAPIDE (BR) W/ORTHOCORD
FDA Adverse Event
Malfunction
·DEPUY MITEK·Product code MAI·May 6, 2013
PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 50MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LPH·September 16, 2014
AORTIC CUTTER 3.8MM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC.·Product code FZT·April 19, 2011
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·March 27, 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