9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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The Hammertoe Correction System
FDA 510(k)
FDA Class 2
·Orthopedic
FULL BREATH SLEEP APPLIANCE - PB (POSTERIOR BITE AND PBB (POSTERIOR BITE WITH BUMPS)
FDA 510(k)
FDA Class 2
·Dental
RL, UL, SL, EL, AND EPL VERTICAL PLATFORM LIFTS
FDA 510(k)
FDA Class 2
·Physical Medicine
XCELA
FDA Adverse Event
Injury
·PFM MEDICAL CPP SA·Product code LJT·May 11, 2026
SPRINT QUATTRO
FDA Adverse Event
Malfunction
·MPRI·Product code LWS·June 8, 2013
ASR 300 SPIKED CUP SIZE 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·April 29, 2011
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIQ·September 8, 2008
CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual unit and also part of the lnflatoball Pessary Kit. Product Usage: The lnflatoball Pessary is a single-patient use pessary manufactured from natural latex rubber and is used for treating cystocele and/or rectocele associated with procidentia or prolapse. The inflatoball Pessary contains one (1) Pessary in a double-pocketed sealed clear plastic pouch, one pocket containing the Pessary and one pocket containing the Instructions for Use (IFU).
FDA Enforcement
Class II
·Terminated·CooperSurgical, Inc.·May 17, 2017
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023