20 results
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19ms
·
Sources: EU EUDAMED, US FDA
DIAMEDIX IS-RUBELLA IGM CAPTURE TEST SYSTEM
FDA 510(k)
FDA Class 2
·Microbiology
Implant Prosthetics
FDA UDI
Preat Corporation·00842092130568·Biomet 3i Certain®-compatible 5.0mm Straight Mu...
Implant Prosthetics
FDA UDI
Preat Corporation·00842092104484·Biomet 3i Certain®-compatible 5.0mm Straight Mu...
BD INTEGRA¿SYRINGE WITH DETACHABLE NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code MEG·February 6, 2018
MaxTorque™
FDA UDI
TORNIER, INC.·00846832054275·
SERAGARD VASCULAR ACCESS PATCH
FDA 510(k)
FDA Class 2
·General Hospital
ASSAYED QCS 1,2, CAT. NOS. 970200, 970500
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PREMIUM PLUS CEEA
FDA Adverse Event
Malfunction
·US SURGICAL PUERTO RICO·Product code GDW·April 19, 2018
PICC NATE
FDA Adverse Event
Injury
·UTAH MEDICAL PRODUCTS, INC.·Product code LJS·January 12, 2007
PICC NATE
FDA Adverse Event
Injury
·UTAH MEDICAL PRODUCTS, INC.·Product code LJS·January 12, 2007
6800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 12, 2013
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·February 25, 2011
POLYFLUX CAPILLARY DIALYZER
FDA Adverse Event
Malfunction
·GAMBRO DIAYLZATOREN GMBH·Product code KDI·February 25, 2008
PICC-NATE
FDA Adverse Event
Injury
·UTAH MEDICAL PRODUCTS·Product code DQO·April 28, 2004
SYRINGE INTEGRA 3ML LL W/NDL 25X5/8 RB
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code MEG·August 15, 2019
Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·March 27, 2013
Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS
FDA Enforcement
Class II
·Terminated·Natus Medical Incorporated·December 21, 2016
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024
BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine. In most cases, the customer ordered both a BleaseFocus anesthesia workstation and a 700/900 ventilator. In some cases, the customer may order a 700/900 stand-alone ventilator would could be used with a BleaseFocus anesthesia workstation at a later date.
FDA Enforcement
Class II
·Terminated·Del Mar Reynolds Medical, Ltd.·December 26, 2012
Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
FDA Enforcement
Class II
·Ongoing·Covidien·August 28, 2024