10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471122963·K-WIRE - SINGLE TROCAR 0.9mm DIA x 150mm
AUTOCHECK 6+, LEVEL 3, S7855
FDA UDI
Radiometer Medical ApS·05700699440969·S7855 AutoCheck 6+, level 3 box of 30 ampoules,...
PHOTAC-BOND
FDA 510(k)
FDA Class 2
·Dental
WET DRESSING SALINE-STERILE
FDA 510(k)
FDA Unclassified
·Unknown
ACRYSOF IQ TORIC
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·February 1, 2013
EPIDURAL CATHETERIZATION SET
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC·Product code CAZ·December 3, 2010
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·July 18, 2014
DIMENSION EXL 200
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code JJE·July 23, 2013
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