18 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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POWDER FREE NITRILE EXAMINATION GLOVES, ORANGE (ORANGE SCENTED), WHITE (VANILLA SCENTED)
FDA 510(k)
FDA Class 1
·General Hospital
Victoria Klein
FDA UDI
Diversified Products, Inc.·00037741909248·
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668111024·INSTRUMENT CADDY MEDIUM
Cosmolock
FDA UDI
Kalitec Direct LLC·B07310K0122000·Assembly, Tab Breaker, Extended Tab
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702641653·ELVAREX 2/MID THIGH HIGH/SLANT, OPEN TOE, E-VER...
Victoria Klein
FDA UDI
Diversified Products, Inc.·00842894122761·
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702357882·Elvarex 2/Knee High/Closed Toe-Elephantiasis-Ve...
qube
FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522102554·DOCKING STATION,91390
CAPELLA
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
1.5T INFINITY TWINSPEED MR SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
6" SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, ROTATING
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FMG·July 23, 2024
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·July 2, 2019
FLEXICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·May 3, 2013
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·September 3, 2014
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 27, 2011
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·March 27, 2020
EVOLUT FX DCS
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 25, 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