23 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CAPIOX ARTERIAL FILTER
FDA 510(k)
FDA Class 2
·Cardiovascular
Duesseldorf Type Bell Partial Titanium
FDA UDI
Heinz Kurz GmbH·EHKM10020261·Ossicular Prosthesis, partial
artVeneer life
FDA UDI
Merz Dental GmbH·D7092002026·artVeneer life upper posteriors, S, A3
Knob
FDA UDI
ADLER ORTHO SPA·08050507132607·KNOB FOR MALLEOLAR ROD TIBIAL CUT
Fuji Cervical Plate System
FDA UDI
Altus Spine, LLC·00843210133270·Variable Angle Centralizer
mahe medical GmbH
FDA UDI
mahe medical gmbh·04050659162761·2.0 Cortex Screw, hex, St.Steel, L 26 mm_x000D_...
NGB-003 Needle-guided Bracket/DETACH
FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904042039·
Alex TriVantage
FDA UDI
Candela Corporation·00817495020846·Pulsed Laser
MCCOY'S 5A MEDIUM, CATA NO. 200-2026
FDA 510(k)
FDA Class 1
·Hematology
APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DISPOSABLE POWDER FREE NITRILE EXAM GLOVES, WHITE COLOR
FDA 510(k)
FDA Class 1
·General Hospital
MAGNA SITE TISSUE EXPANDER
FDA Adverse Event
MCGHAN MEDICAL CORP.·Product code LCJ·May 17, 1994
SCREWDRIVER HANDLE, RATCHETING
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code LXH·June 9, 2023
BIZACT
FDA Adverse Event
Injury
·COVIDIEN·Product code GEI·February 2, 2026
DUROM US ACETABULAR COMPONENT 52/46 L
FDA Adverse Event
Other
·ZIMMER GMBH·Product code KWA·March 11, 2013
PUMP/GRAVITY SOLUTION NO 'Y' SITE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code FPA·February 27, 2011
HEARTMATE 2 LVAD
FDA Adverse Event
Death
·THORATEC·Product code DSQ·February 25, 2008
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
ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare, Llc·February 5, 2014
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