2,841 results
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32ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER
FDA 510(k)
FDA Class 2
·Cardiovascular
OsteoMed
FDA UDI
OSTEOMED LLC·00845694001069·2.0mm x 14mm MMF Auto-Drive Screw
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193102238·EVOS Rotate HA PEEK 14mm x 12mm x 30mm Flat, 5°...
DELTA
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613252496793·Delta 1.7mm Triangular plate - 30mm
Micasept Fenestrated Grasping Forceps
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896118218·Micasept Fenestrated Grasping Forceps Rhombic C...
Minuteman
FDA UDI
Spinal Simplicity, LLC·M9432000920140·Insertion Adaptor, Extended, Sz. 14mm
OsteoMed
FDA UDI
OSTEOMED LLC·00845694062985·2.0 MMF x 14mm Screw Sterile Qty 5
N LATEX IGM
FDA 510(k)
FDA Class 2
·Immunology
MODIFICATION TO BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CURRENT RF DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL INC., CRMD·Product code LWS·January 13, 2014
SETROX S 53
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVN·May 3, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·May 18, 2011
OT PING ENHANCED METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 31, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·December 31, 2014
ROUND BLAKE HUBLESS SILICON DRAINS - 3/4 FLUTED
FDA Adverse Event
Injury
·ETHICON INC.·Product code KOG·July 7, 2015
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 21, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 6, 2014
Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. Device Name: Osseocare Pro console & Set Osseocare Pro. Model: 1600870-001, 1700470-001, 1700471-001. Marketing status: Class I, under K092214. Device description: Software-based, electronically controlled tabletop device. In dentistry for dental surgery, endodontics and implantology.
FDA Enforcement
Class II
·Terminated·Nobel Biocare Usa Llc·November 20, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 17, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 11, 2014