13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K
FDA 510(k)
FDA Class 2
·General Hospital
SunTech
FDA UDI
SUNTECH MEDICAL, INC.·10840935109693·
POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES, CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN P
FDA 510(k)
FDA Class 1
·General Hospital
EVANTGARDE/ENDEAVOR POWERED WHEELCHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
PRIME BIG WHEEL STRETCHER,30"
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·March 13, 2013
UNKNOWN DEPUY ASR HIP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 17, 2011
8800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS, INC.·Product code JAA·February 26, 2008
PRESIDIO 10 - CERECYTE MICROCOIL
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code HCG·June 9, 2016
PRESIDIO 18 - CERECYTE MICROCOIL
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code HCG·June 9, 2016
UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 30, 2015
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
Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
FDA Enforcement
Class II
·Ongoing·Covidien·August 28, 2024