22 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ACTIVE WASTE GAS SCAVENGER
FDA 510(k)
FDA Class 2
·Anesthesiology
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16711109300·
N/A
FDA UDI
GEORGE TIEMANN & CO.·B5821109300·FORCEPS, DRESSING, DENTAL
Ardis®
FDA UDI
ZIMMER SPINE, INC.·00889024333741·
Fletcher CT/MR Shielded Applicator
FDA UDI
Nucletron B.V.·08717213024250·Shielded Ovoid Tube 1
Posted Stainless Steel Archwire
FDA UDI
Ortho Arch Company Inc·D90911093011·.019 X .025 POSTED SS RIGHT FORM WIRES 30MM (10)
Ardis®
FDA UDI
ZIMMER SPINE, INC.·00889024334472·
ZEUS-P
FDA UDI
SPINAL ELEMENTS·00840916153328·Zeus-P Trial, 11 x 9 x 30mm
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
KENSTONE METAL·Product code ITJ·July 20, 2012
GentleLASE
FDA UDI
Candela Corporation·00817495020792·Pulsed Laser
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1671001109300·
INFINION CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·February 14, 2025
PRIMEWIRE PRESTIAGE PRESSURE GUIDE WIRE, MODELS 8185, 8185J, 8300, 8300J
FDA 510(k)
FDA Class 2
·Cardiovascular
LIFT VB SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ADJUSTABLE T-PIECE AND RESUSCITATION CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTL·December 21, 2011
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL- NEUROMODULATION·Product code LGW·May 8, 2013
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 8, 2014
OCULIGHT GLX LASER
FDA Adverse Event
Malfunction
·IRIDEX CORP.·Product code HQF·March 25, 2011
Lactosorb RapidFlap, bone plate, Model No. 915-0020 The RapidFlap LS Cranial Fixation System is indicated for use in pediatric craniotomy flap fixation.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·May 16, 2018
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Enforcement
Class I
·Ongoing·Covidien·November 8, 2023