15 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Mico One Orthodontic Screw
FDA 510(k)
FDA Class 2
·Dental
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112823·BARRON VACUUM PUNCH 9.25MM
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112724·BARRON VACUUM PUNCH 6.75MM
24M - Nevada Energy - Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588011639·24M - Nevada Energy - Metal
PINN DELTA CER INSRT 58ODX36ID
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code MRA·January 3, 2012
WELCH ALLYN SPOT VITAL SIGN MONITOR WITH MP506
FDA 510(k)
FDA Class 2
·Cardiovascular
MICROSTREAM EXTERNAL BATTERY CHARGER
FDA 510(k)
FDA Class 2
·Anesthesiology
OT ULTRAMINI METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE GMBH·Product code NBW·June 20, 2019
GE OEC 8800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·October 16, 2008
UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE T
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL S.A·Product code GFA·June 28, 2013
SCREW-IN
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011
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
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·January 22, 2025