9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LSPI AUTOMATIC VENTILATOR, MODEL AV2000-100
FDA 510(k)
FDA Class 2
·Anesthesiology
N APOLIPOPROTEIN STANDARD SERUM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BREAST VOLUME NAVIGATOR
FDA 510(k)
FDA Class 2
·Radiology
1.5 LACTOSORB SYSTEM 1.5 X 5 MM LACTOSORB SCREW
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HRS·August 22, 2018
NA
FDA Adverse Event
Malfunction
·STERILMED, INC.·Product code NMJ·June 3, 2014
LCS COMPLETE FEM CEM R STD
FDA Adverse Event
Injury
·DEPUY IRELAND ¿ REG. # 9616671·Product code NJL·February 4, 2013
ACRYSOF IQ TORIC
FDA Adverse Event
Other
·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·December 17, 2010
BIOMET BONE CEMENT R 1X40 US
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code LOD·June 4, 2024
PKG, GRASPER FORCEP, BOWEL, P/N 0250080324. 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