14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PAD
FDA 510(k)
FDA Class 2
·Cardiovascular
CoRoent
FDA UDI
Nuvasive, Inc.·00887517231796·CoRoent XLW 15°, 12x22x60mm
NuVasive
FDA UDI
Nuvasive, Inc.·00887517291431·CoRoent XL-XW, 12x24x60mm 10°
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690192275·Revision Knee Reamer Spiral Fluted - Zimmer 26mm
A/C ENZYMATIC VITAMIN B6 ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SCHUCO MIST AND SCHUCO DELUXE MIST
FDA 510(k)
FDA Class 2
·Anesthesiology
COMPREHENSIVE REVERSE BASE PLATE HA+ ADAPTOR
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·March 27, 2018
CANCELLOUSSCR Ø4 L60 SST
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWC·June 7, 2013
ASR ACETABULAR CUPS 56
FDA Adverse Event
Injury
·DEPUY INTL. LTD.·Product code KWA·June 30, 2011
2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/5 HOLES/RIGHT
FDA Adverse Event
Malfunction
·SYNTHES ELMIRA·Product code HRS·October 8, 2014
Precise Digital Accelerator Delivery of radiation to defined target volumes
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 26, 2012
SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 26, 2014
Precise Treatment Table. To be used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 17, 2013
All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 12, 2014