8 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD4, CLONE MT310, FITC-CONJUGATED, (ANTI-CD4/FITC, MT310) RPE-CONJUGATED, (ANTI-CD4/
FDA 510(k)
FDA Class 2
·Hematology
GIOTTO PATIENT BED
FDA 510(k)
FDA Class 2
·Radiology
IMMITTANCE METER, MODEL AE-105D/S
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
X-COATED CAPIOX SX W/HARDSHELL RESERVOIR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEM CORP·Product code DTZ·January 31, 2013
CROSSER RECANALIZATION CATHETER
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·December 10, 2010
SEE H-10
FDA Adverse Event
Malfunction
·STAAR SURGICAL COMPANY·Product code HQL·July 18, 2014
CORIN BIOLOX DELTA HEAD
FDA Adverse Event
Injury
·CORIN LTD (UK & FR)·Product code LZO·November 22, 2022
PKG, ALLIGATOR FORCEPS, P/N 0250080316. 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