23 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MIASPAS MINITTA ANTERIOR MICRO SURGICAL TRANSTHORACIC APPROACH INSTRUMENTATION
FDA 510(k)
FDA Class 2
·Orthopedic
Preat
FDA UDI
Preat Corporation·00842092169858·Multi-Unit Scan Body w/Unigrip Screw. kit conta...
SCANLAN® Titanium Forceps
FDA UDI
SCANLAN INTERNATIONAL INC·00846159003598·Gerald DeBakey Forceps, Flat Handle, 1 mm tips,...
QUASAR
FDA UDI
Modus Medical Devices Inc·G34350037400·MRgRT Insight - Dual Ion Chamber Holder Accessory
KSEA MONOPOLAR VAPORIZATION ELECTRODES
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ASAHI STERILE ACUPUNCTURE NEEDLE TYPE S
FDA 510(k)
FDA Class 2
·General Hospital
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·January 26, 2012
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·January 26, 2012
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC INC.·Product code KWP·October 15, 2009
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC INC.·Product code KWP·December 31, 2009
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC INC.·Product code KWP·October 29, 2009
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·February 12, 2013
ARCTIC FRONT CARDIAC CRYOABLATION CATHETER
FDA Adverse Event
Injury
·MEDTRONIC CRYOCATH LP·Product code OAE·February 24, 2011
UV-FLASH SOLUTION TRANSFER SET (SHORT) - JAPAN
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·February 21, 2008
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 21, 2010
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 21, 2010
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC INC.·Product code KWP·August 13, 2010
EVOLUT FX DCS
FDA Adverse Event
Death
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·February 24, 2025
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
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