17 results · 28ms · Sources: EU EUDAMED, 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