13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DynaFuse Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
24M - The Braun Corp - Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588095950·24M - The Braun Corp - Metal
BURETTE-IN LINE (150 ML)
FDA 510(k)
FDA Class 2
·General Hospital
ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
SILICONE ADVANCED OPTIC-VIOLET SHIELD
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code HQL·October 16, 2008
ASKU
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code DQY·August 11, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·July 3, 2013
20 G X 1.16" BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·October 9, 2017
UNKNOWN, VAP CLOSED SUCTION CATHETERS & ACCESSORIES
FDA Adverse Event
Malfunction
·AVANOS MEDICAL INC.·Product code BSY·October 14, 2022
ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, ATAR 53912 Disposable Series, and XI Disposable Series. Model codes: ATAR D-A DARK BLUE DISPOSABLE, ATAR D-V WHITE DISPOSABLE, ATAR D-MDT DISPOSABLE, ATAR D-T DISPOSABLE, ATAR D-R DISPOSABLE, ATAR D-RL DISPOSABLE, ATAR D-MDTL DISPOSABLE, ATAR D-MDTS, ATAR D-R1 DISPOSABLE, ATAR D-R NP DISPOSABLE, ATAR D-MDT2, ATAR D-MDTR, ATAR D-R D2P, ATAR D-R T4P, ATAR D-R X2, ATAR D-V2, ATAR D-IS1-2PACE, PACE 101H, PACE 203H WITH ATAR D-MDTS, PACE 203H, PACE 101H WITH ATAR D-T, PACE 300, XI.D-A, DARK BLUE, DISPOSABLE, XI.D-V WHITE DISPOSABLE, XI.D-MDT DISPOSABLE 30 CM, XI.D-T DISPOSABLE, XI.D-RL, XI.D-R DISPOSABLE, 53912D - MDTS ATAR DISPOSABLE Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker
FDA Enforcement
Class I
·Terminated·Oscor, Inc.·July 19, 2017
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
Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
FDA Enforcement
Class I
·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024