12 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DURADIAGNOST
FDA 510(k)
FDA Class 2
·Radiology
Mckesson
FDA UDI
MCKESSON MEDICAL-SURGICAL INC.·00612479188228·GLOVE, EXAM POLYMER LTX PF SM
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515018945·Kocher Fcps, slim, str, 5 1/2"
ELEFANT SUCTION-IRRIGATION DEVICE
FDA Adverse Event
Malfunction
·COLOPLAST A/S·Product code FQH·July 6, 2023
MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
HORIZONTAL-VERTICAL LUMBAR VALVE AND SPETZLER LUMBAR PERITONEAL SHUNT SYSTEMS
FDA 510(k)
FDA Class 2
·Neurology
ACL ADVANCE
FDA Adverse Event
INSTRUMENTATION LABORATORY CO.·Product code JPA·July 13, 2005
BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FPA·May 15, 2019
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 3, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
PINNACLE SECTOR II CUP 52MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·June 8, 2011
PKG, NEEDLE HOLDER, CURVED LEFT, P/N 0250080341. 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