17 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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WATERPAP VALVE
FDA 510(k)
FDA Class 2
·Anesthesiology
CD HORIZON® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000887940·CROSSLINK 8110713 ANTERIOR 13MM
CD HORIZON® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00721902844720·CROSSLINK 8110713 ANTERIOR 13MM
STARLED5 NX
FDA UDI
ACEM SPA·08050705890569·STARLED5 NX 1-ARM CEILING MODULAR LINE
Ormco
FDA UDI
ORMCO CORPORATION·00889989028553·SS BROAD ARCH LO LGE 0180X0250 PK/10
Medetz Surgical Instruments
FDA UDI
Medetz Surgical Instruments LLC·G2231107130·Koch stop and chop manipulator, 4 3/8", angled ...
Apollo Anterior Cervical Plate System
FDA UDI
AURORA SPINE, INC.·B5211107130·AO Quick Connect Silicone Handle, Black
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306803383·Horizontal Bar
LIPCOLLECTOR II
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EMS AIR-FLOW MASTER PIEZON
FDA 510(k)
FDA Class 2
·Dental
BD INSULIN PEN NEEDLE
FDA Adverse Event
Injury
·BECTON DICKINSON AND CO.·Product code FMI·November 9, 2015
ENDOWRIST
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code NAY·October 6, 2022
VERTEBRAL AUGMENTATION ACCESS KIT
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code MQP·May 14, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 23, 2014
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 1, 2011
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024
EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021