8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EXCEL-P FORMULA AUTO-CURE DENTURE BASE
FDA 510(k)
FDA Class 2
·Dental
ABL80 SC80
FDA UDI
Radiometer Medical ApS·05700699457110·SC80 300/15 Full-OX noGlu, QC3
BACT/ALERT FAN AEROBIC CULTURE BOTTLE
FDA 510(k)
FDA Class 1
·Microbiology
IN THE EAR HEARING AID
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
PFC PATELLA
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·December 30, 2010
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 21, 2014
CORE PARTIAL BASE
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·December 7, 2012
PKG, 3MM PEEK MONOPOLAR HANDLE, P/N 0250282045 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