13 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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INTRABEAM NEEDLE APPLICATOR
FDA 510(k)
FDA Class 2
·Radiology
Marienfeld Superior
FDA UDI
Paul Marienfeld GmbH & Co. KG·04250317328618·
TRESTLE LUXE
FDA UDI
ALPHATEC SPINE, INC.·00190376215372·TRESTLE LUXE II, ACP, 5-LEVEL, 90
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·December 31, 2014
NEUROPACK MICRO, MODEL MED-9100A SERIES
FDA 510(k)
FDA Class 2
·Physical Medicine
EDGE CO2 LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TPRLC 133 T1 PPS SO 12X144MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·November 27, 2019
TI STERNAL LOCKING STAR PLATE-12 HOLES
FDA Adverse Event
Injury
·SYNTHES ELMIRA·Product code HRS·May 14, 2013
TIP FOR DHS®/DCS® IMPACTOR
FDA Adverse Event
Malfunction
·SYNTHES HAGENDORF·Product code HWA·September 23, 2014
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·June 1, 2011
Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.
FDA Enforcement
Class II
·Terminated·Pentax of America Inc·August 30, 2017
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