19 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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31HN713D
FDA 510(k)
FDA Class 2
·Radiology
HHM
FDA UDI
Oticon A/S·05707131354853·G500 SC, MINIRITE 312 2.4G C046 HHM
Symmetry Hayes
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482040188·Symmetry® Retractor, Hayes Hand, 7.5 mm, 6 in
GYRUS ENT COGENT 2/G2 SYSTEM (GENERATOR,ACCESSORIES SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODEL CGS TILT SEATING SYSTEM FOR POWER WHEELCHAIRS
FDA 510(k)
FDA Class 2
·Physical Medicine
HNM MEDICAL
FDA UDI
HNM STAINLESS, LLC.·00842962112854·HAYES HAND RETRACTOR, 6 1/4", 6MM
GE OEC 9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·October 21, 2008
ATTAIN ABILITY
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code OJX·August 11, 2011
CAPSUREFIX NOVUS
FDA Adverse Event
Death
·MPRI·Product code DTB·July 2, 2013
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 18, 2013
BD CATHENA¿ SAFETY IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·May 19, 2022
NATURA
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code EXE·April 25, 2023
NATURA
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code EXE·April 25, 2023
NATURA
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code EXE·April 25, 2023
NATURA
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code EXE·April 25, 2023
NATURA
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code EXE·April 25, 2023
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
TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart. TB is packaged for sterile single use in a double tray. The lead is placed in a PETG inner tray that is sealed with a Tyvek inner lid. The sealed inner tray is placed in an outer PETG tray. The outer tray is sealed with an outer Tyvek lid. An inner label is placed on the outer Tyvek lid. The sealed trays are placed in a labeled white shelf box with on Instruction for use. Packed on lead per outer white shelf box.
FDA Enforcement
Class I
·Terminated·Oscor, Inc.·November 14, 2018
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