14 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SHENGKUN CHEMICAL
FDA 510(k)
FDA Class 1
·General Hospital
Globe Scientific
FDA UDI
GLOBE SCIENTIFIC INC.·00840095600873·Sample Cup, 2.0mL, PS, 1000/Bag
Hohmann Retractor 15mm Width
FDA UDI
Osteocentric Technologies, Inc.·00816950028526·Hohmann Retractor 15mm Width
Leva® Anterior Interbody System
FDA UDI
Spine Wave, Inc.·10840642112535·Modular Spacer, 26 mm (W) x 26 mm (L) x 15 mm (...
TORNIER STAYFUSE GREAT TOE INTERPHALANGEAL IM
FDA Adverse Event
Malfunction
·TORNIER INC.·Product code NDF·October 22, 2009
LITE ART
FDA 510(k)
FDA Class 2
·Dental
ACCU-SPACE ABSORBABLE SEEDING SPACERS
FDA 510(k)
FDA Class 2
·Radiology
BD ULTRA FINE¿ PEN NEEDLES
FDA Adverse Event
Injury
·BECTON DICKINSON AND CO.·Product code FMI·May 7, 2019
QUATTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 10, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·September 23, 2014
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·June 1, 2011
MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to cover the Medrad Avanta Sterile Hand Controller to prevent cross contamination between patients.
FDA Enforcement
Class II
·Terminated·Medrad Inc·February 27, 2013
Video Duodenoscope
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·June 8, 2016
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