9 results
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17ms
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Sources: EU EUDAMED, US FDA
ULTRASOUND PROBE DRAPE
FDA 510(k)
FDA Class 2
·Radiology
XLIF
FDA UDI
Nuvasive, Inc.·00887517406736·XLIF Cutter, 8mm Disc
OASIS BILIARY STENT INTRODUCTION SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT
FDA 510(k)
FDA Class 2
·Cardiovascular
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 2, 2013
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·December 23, 2010
UNKNOWN DEPUY 52 LOCKING RING
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWA·July 17, 2014
PKG, 5MM X 33CM INSERT, JOHANN FORCEPS, P/N 0Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life. 250080763
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014
Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.
FDA Enforcement
Class II
·Terminated·Capintec Inc·April 1, 2020