22 results · 23ms · Sources: EU EUDAMED, 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