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Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank

FDA 510(k)
FDA Class 2 ·Dental

GOLD CORE PLUS

FDA 510(k)
FDA Class 2 ·Dental

REMVIEW SLEEP RECORDER, MODEL 320

FDA 510(k)
FDA Class 2 ·Neurology

MONOPOLAR CURVED SCISSORS INSTRUMENT

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL, INC.·Product code GEI·October 17, 2008

CARELINK

FDA Adverse Event
Malfunction ·PLEXUS MANUFACTURING SDN. BHD·Product code KRG·August 11, 2011

UNKNOWN IMPLANTABLE NEUROSTIMULATOR

FDA Adverse Event
Malfunction ·MEDTRONIC NEUROMODULATION·Product code LGW·July 2, 2013

EMBLEM MRI S-ICD Model A219

FDA Enforcement
Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

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

EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021