15 results · 23ms · Sources: EU EUDAMED, US FDA

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SleepWeaver Advance Pediatric Nasal CPAP Mask

FDA 510(k)
FDA Class 2 ·Anesthesiology

ProLift

FDA UDI
Life Spine, Inc.·00190837106485·Static Expandable Cage Trial, 10mm x 28mm x 12m...

INFINITI CYP2C19 ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

POWDER-FREE SYNTHETIC VINYL EXAM GLOVES WITH VITAMIN E COATING

FDA 510(k)
FDA Class 1 ·General Hospital

PENUMBRA SYSTEM MAX ASPIRATION TUBING

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code NRY·June 24, 2015

ILAB? POLARIS MULTI-MODALITY GUIDANCE SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQK·May 14, 2026

INSIGNIA

FDA Adverse Event
Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 6, 2011

PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

FDA Adverse Event
Injury ·RICE CREEK MFG·Product code LWP·June 7, 2013

FOOT CHOICE THERAPEUTIC DEVICE

FDA Adverse Event
Injury ·YAS HEALTHY FITNESS CO. LTD.·Product code ISA·September 4, 2008

TDC VELOCE", 27G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT27, 9311.27G01, 9311.27G02, 9311.27K01, 9311.27K02, 9311.27K03, 9627.G0101, 9627.G0201, 9311.27G01-00;

FDA Enforcement
Class II ·Ongoing·D.O.R.C. Dutch Opthalmic Research Center Intl B.V.·June 17, 2026

SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·March 26, 2014

Precise Treatment Table. To be used as part of radiation therapy treatment process.

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·April 17, 2013

All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·March 12, 2014

Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·April 9, 2014

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