29 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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EVERSTICK POST
FDA 510(k)
FDA Class 1
·Dental
Hern Dilator
FDA UDI
MEDGYN PRODUCTS, INC.·M803030820·Hern Dilator 80Fr (26.6 mm)
Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)
FDA UDI
TENON MEDICAL, INC.·B74240308200·10mm Location Pin
Kalitec Universal Instruments
FDA UDI
Kalitec Direct LLC·B07301K0380200·Handle, Threaded Standard Dynamo
neoWave LS
FDA UDI
XENIX MEDICAL LLC·00818345023871·BAYONETTED STRAIGHT RING CURETTE
DISPOSABLE CB-PE MICROKERATOME BLADES
FDA 510(k)
FDA Class 1
·Ophthalmic
AVANAR F/X 2.9F INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 85700
FDA 510(k)
FDA Class 2
·Cardiovascular
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC, INC.·Product code KWP·March 15, 2011
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·September 26, 2016
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·July 26, 2016
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·September 11, 2017
APPLIANCE, FIXATION, SPINAL INTERLAMINAL
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·October 25, 2017
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·April 4, 2016
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·April 6, 2017
GYNECARE MORCELLEX* TISSUE MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code HET·April 2, 2013
TERUMO CDI 101 MONITOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP·Product code DTY·March 4, 2011
TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DRS·April 17, 2008
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·February 7, 2020
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·October 3, 2011
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·September 30, 2011