14 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Small Bone Nail Implant
FDA 510(k)
FDA Class 2
·Orthopedic
OMNI Mod Hip
FDA UDI
Omni Life Science, Inc.·00841690102786·OMNI Modular Stem Size 6, 14.5mm
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776186715·LITTLER SUTUTE SCISSORS CRV WHOLE
ProLift Trial
FDA UDI
Life Spine, Inc.·00190837087937·
HNM SPORTS MEDICINE
FDA UDI
HNM STAINLESS, LLC.·00842962101841·ETHOS PRO SMALL JOINT ANCHOR, PEEK, 2.9mm x 10m...
ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRATOR CALIBRATOR FOR AUTOMATED SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SENTINEL CERULOPLASMIN
FDA 510(k)
FDA Class 2
·Immunology
HNM SPORTS MEDICINE
FDA UDI
HNM STAINLESS, LLC.·00842962104057·ETHOS PRO SMALL JOINT ANCHOR, PEEK, 2.9mm x 10m...
OMNIPOD INSULIN PUMP
FDA Adverse Event
Other
·INSULET CORPORATION·Product code LZG·January 16, 2009
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 8, 2014
NON-PVC RECEPT LINER 2000ML/CE(50/CS)
FDA Adverse Event
Malfunction
·HOSPIRA, LTD.·Product code GCX·June 21, 2011
TENDRIL STS
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code NVN·October 15, 2015
ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
Medical Linear Accelerator
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 14, 2016