8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HEPA AIR CLEANER
FDA 510(k)
FDA Class 2
·General Hospital
WOUNDCLOT HEMOSTATIC GAUZE
FDA 510(k)
FDA Unclassified
·Unknown
NOBEL BIOCARE PERMANENT CENTRIC POST, MODELS 31234, 31235, 31236
FDA 510(k)
FDA Class 2
·Dental
QUATTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZF·June 18, 2014
SOLUTION ADMINISTRATION SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code FPA·December 29, 2010
EON
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·January 30, 2013
PKG, ATRAUMATIC FORCEPS, DOUBLE ACTION, P/N 0250080311. 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
CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026