10 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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THE EXPANDACELL EAR PACK
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
FIXOS
FDA UDI
Stryker GmbH·07613252708759·Screw-Rack 4.0mm
Trinias
FDA UDI
SHIMADZU CORPORATION·04540217048939·
URINE AMPHETAMINE/METHAMPHETAMINE SCREEN FLEX REAGENT CARTRIDGE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
INFUSET FLOW CONTROL EXTENSION SET
FDA 510(k)
FDA Class 2
·General Hospital
V.A.C. THERAPY
FDA Adverse Event
Injury
·KCI USA INC.·Product code OMP·June 19, 2014
ALLEGRETTO WAVE EYE-Q
FDA Adverse Event
Malfunction
·WAVELIGHT GMBH·Product code LZS·December 22, 2010
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 2, 2013
PKG, 5MM INSERT, 45CM, DEBAKEY FORCEPS, P/N 0250080748 Laparoscopic 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.
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