12 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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EMG SUCTION UNIT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
n/a
FDA UDI
HANS RUDOLPH, INC.·00874750006373·2600C 2WAY NRBV 1.125OD MPORT
Chisel
FDA UDI
ELLIQUENCE, LLC·00846338002220·
SIRONA DENTAL CAD/CAM SYSTEM
FDA 510(k)
FDA Class 2
·Dental
DISPOSABLE INSULIN SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
M2A-MAGNUM MOD HD SZ 50MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·May 14, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 24, 2014
ADVANTA BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·April 28, 2011
DREAMSTATION AUTO CPAP
FDA Adverse Event
Injury
·RESPIRONICS, INC.·Product code BZD·March 21, 2022
MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to cover the Medrad Avanta Sterile Hand Controller to prevent cross contamination between patients.
FDA Enforcement
Class II
·Terminated·Medrad Inc·February 27, 2013
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025