11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Stealth Staple System
FDA 510(k)
FDA Class 2
·Orthopedic
NATRELLE Saline-Filled Breast Implants
FDA UDI
Allergan, Inc.·10888628000711·STYLE 163 440CC Full Projection BIOCELL |textur...
Best Medical International
FDA UDI
BEST MEDICAL INTERNATIONAL, INC.·00841365103612·
PADDLE, TROCAR, RECON MODE T2 RECON
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS ¿ KIEL·Product code HSZ·June 14, 2012
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·October 18, 2021
EVEREST SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
HIGH FIVE
FDA 510(k)
FDA Class 1
·General Hospital
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code IOR·June 11, 2013
COGNIS
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 15, 2011
ACCU-CHEK SPIRIT CARTRIDGE
FDA Adverse Event
Malfunction
·DISETRONIC MEDICAL SYSTEMS·Product code LZG·September 10, 2008
Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019