11 results · 20ms · Sources: EU EUDAMED, US FDA

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CPR EZY MASK AND PAD

FDA 510(k)
FDA Class 2 ·Cardiovascular

IVC TWO MEDIUM

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

MEDLINE ELECTRONIC POSITIONING CHAIR

FDA 510(k)
FDA Class 2 ·Physical Medicine

HEARTMATE II LVAS

FDA Adverse Event
Injury ·THORATEC CORP.·Product code DSQ·March 12, 2013

PENTA SURGICAL LEAD

FDA Adverse Event
Injury ·ST JUDE MEDICAL- NEUROMODULATION DIVISION·Product code LGW·February 24, 2011

MAYFIELD

FDA Adverse Event
Malfunction ·INTEGRA LIFESCIENCES CORPORATION·Product code HBL·January 29, 2008

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·January 15, 2026

iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100, Catalog #s: 800-3046, 800-3047, 800-3052, 800-3053, 800-3802, 800-3803, 800-3900, 800-3920, 800-3925, 800-3931, 800-3933, 800-3934, 800-3935, 800-3937, 800-3950, 800-3951, 800-3042, 800-3043, 800-3044, 800-3049, 800-3050, 800-7190, 800-7713, 800-7714, 800-7715, 800-7101, 800-7102, 800-3938, 800-7157

FDA Enforcement
Class II ·Terminated·Beckman Coulter Inc.·April 18, 2018

iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100, Catalog #s: 800-3046, 800-3047, 800-3052, 800-3053, 800-3802, 800-3803, 800-3900, 800-3920, 800-3925, 800-3931, 800-3933, 800-3934, 800-3935, 800-3937, 800-3950, 800-3951, 800-3042, 800-3043, 800-3044, 800-3049, 800-3050, 800-7190, 800-7713, 800-7714, 800-7715, 800-7101, 800-7102, 800-3938, 800-7157

FDA Recall
Terminated ·Beckman Coulter Inc.·Product code KQO·November 10, 2017

Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.

FDA Enforcement
Class II ·Terminated·Unomedical As·July 1, 2015

CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024