13 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IONSIL GEL
FDA 510(k)
FDA Unclassified
·Unknown
HHM
FDA UDI
Oticon A/S·05707131258823·H150, MINIRITE 312 WL DBL HHM
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668115138·NAGAHARA/BECHERT MANIPULATOR DOUBLE-ENDED
SMARTTOOLS KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
PARCUS 3.5MM PEEK CF PUSH-IN SUTURE ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
CD HORIZON BALLAST SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NKB·December 9, 2019
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013
ADJ PIN COLLET 2.0-3.2MM
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·June 11, 2011
SWEET TIP
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVN·October 1, 2014
BD BACTEC LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC)
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·October 6, 2021
BD BACTEC LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC)
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·October 6, 2021
BD BACTEC LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC)
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·October 6, 2021
Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides Desiccate Coagulation waveform electrosurgical capability to CUSA Excel handpieces. The CUSA handpiece with the CEM Nosecone works in conjunction with the Force FX generator in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·February 26, 2014