17 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DENTAURUM NO-MIX ONE STEP BRACKET ADHESIVE
FDA 510(k)
FDA Class 2
·Dental
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496030980·STRONG, SIZE XXL, FUMO, MICRO-MASSAGING BERMUDA...
Graves Vu-Max X Long
FDA UDI
MEDGYN PRODUCTS, INC.·M803030980·Graves Vu-Max X Long 7" (178mm)
CRESCENT TINNITUS RETAINING SOUND GENERATOR
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
DIMENSION TPSA CALIBRATOR, MODEL #RC459
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BD INSYTE AUTOGUARD
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·October 4, 2024
INTELLIS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·June 16, 2025
S-ICD SYSTEM
FDA Adverse Event
Malfunction
·CAMERON HEALTH INC·Product code LWS·March 28, 2013
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·August 22, 2014
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·March 22, 2011
CELLEX PHOTOPHERESIS SYSTEM
FDA Adverse Event
Malfunction
·THERAKOS, INC.·Product code LNR·August 17, 2018
Female SS 3.5MM Pellet Insertion Tray Catalog Number: B9175R1
FDA Enforcement
Class II
·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022
BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile, Item 431406.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018
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