14 results
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34ms
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Sources: EU EUDAMED, US FDA
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