14 results · 34ms · Sources: EU EUDAMED, US FDA

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TISSUE PROCESSING SYSTEM

FDA 510(k)
FDA Class 1 ·Pathology

NUPRO® Sensodyne® Prophylaxis Paste with Fluoride and NovaMin®

FDA UDI
DENTSPLY INTERNATIONAL INC.·D0038015131·NUPRO® Sensodyne® Prophy Paste, Peppermint, Sta...

Mini-Sprint®

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78015131·Mini Sprint Bracket McLaugh/Benn/Trev. .018" ma...

Mini-Sprint®

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78015131001·Mini Sprint Bracket McLaugh/Benn/Trev. .018" ma...

Mini-Sprint®

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78015130101·Mini Sprint Bracket McLaugh/Benn/Trev. .018" ma...

Mini-Sprint®

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78015130051·Mini Sprint Bracket McLaugh/Benn/Trev. .018" ma...

MERETE 3.0 AND 3.5 MM LOCKING SCREWS

FDA 510(k)
FDA Class 2 ·Orthopedic

Quantra QPlus System

FDA 510(k)
FDA Class 2 ·Hematology

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 9, 2014

UNKNOWN LANCING DEVICE

FDA Adverse Event
Injury ·LIFESCAN INC.·Product code NBW·October 23, 2012

OT ULTRASMART METER

FDA Adverse Event
Injury ·LIFESCAN, INC.·Product code NBW·August 16, 2010

Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

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