19 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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DISPOSABLE HYPODERMIC NEEDLE ELECTRODE, MODEL 9013S0421,9013S0431,9013S0441,9013S0451,9013S0461,1013S0421,103S0431
FDA 510(k)
FDA Class 2
·Physical Medicine
Custom Procedure Kit
FDA UDI
MEDIVATORS INC.·40677964021006·The ENDO CARRY-ON Procedure Kit contains all of...
ILT 0.014 CATHETER, MODEL C114NL2
FDA 510(k)
FDA Class 2
·Cardiovascular
MACROPOREDX DISTRACTOR SYSTEM
FDA 510(k)
FDA Class 2
·Dental
VENTAK MINI+ IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS·Product code LWS·March 6, 1997
PK DISSECTING FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·March 13, 2013
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·February 8, 2011
ACCU-CHEK SPIRIT
FDA Adverse Event
Injury
·DISETRONIC MEDICAL SYSTEMS·Product code LZG·February 20, 2008
PIPELINE EMBOLIZATION DEVICE
FDA Adverse Event
Injury
·COVIDIEN (IRVINE)·Product code OUT·March 30, 2017
PIPELINE EMBOLIZATION DEVICE
FDA Adverse Event
Injury
·COVIDIEN (IRVINE)·Product code OUT·March 30, 2017
PIPELINE EMBOLIZATION DEVICE
FDA Adverse Event
Injury
·COVIDIEN (IRVINE)·Product code OUT·March 30, 2017
Neptune Rover Waste Management System, Neptune 2 Ultra Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code FYD·June 8, 2012
Stryker Neptune Bronze Rover, Part 0700-007-000 Neptune Bronze Rover Waste Management System Instructions For Use. Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code FYD·June 8, 2012
Neptune 1 Gold Rover (120 Vand 230V ) Waste Management System Part Number 0700-001-000, 0700-002-000(International) Instructions For Use 0700-001-700, 0700-002-707 Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code FYD·June 8, 2012
Neptune 1 Silver Rover, Part 0700-003-000 Stryker Instruments Neptune Rover IFU part 0700-001-700
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code FYD·June 8, 2012
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
OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021
Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
FDA Enforcement
Class II
·Ongoing·Covidien·August 28, 2024