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

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Revolution Peripheral Atherectomy System

FDA 510(k)
FDA Class 2 ·Cardiovascular

ULTRA BEAUTY

FDA 510(k)
FDA Class 2 ·Neurology

BDPROBETEC ET CT/GC AMPLIFIED DNA ASSAY

FDA 510(k)
FDA Class 2 ·Microbiology

MEDLINE-MICROTEK

FDA Adverse Event
Malfunction ·MICROTEK MEDICAL LLC·Product code PUI·February 20, 2026

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE REHABILITATION EQUIP·Product code CAW·October 30, 2014

TREK CORONARY DILATATION CATHETER

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code LOX·August 15, 2011

GYNECARE TVT RETROPUBIC SYSTEM

FDA Adverse Event
Injury ·ETHICON INC.·Product code OTN·July 9, 2013

LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects.

FDA Enforcement
Class I ·Terminated·DePuy Orthopaedics, Inc.·February 27, 2013

BD BBL¿ MIDDLEBROOK OADC ENRICHMENT

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code PPM·September 2, 2025

BD BBL¿ MIDDLEBROOK OADC ENRICHMENT

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code PPM·September 3, 2025

BD BBL¿ MIDDLEBROOK OADC ENRICHMENT

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code PPM·September 2, 2025

BD BBL¿ MIDDLEBROOK OADC ENRICHMENT

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code PPM·September 2, 2025

BD BBL¿ MIDDLEBROOK OADC ENRICHMENT

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code PPM·September 2, 2025

BD BBL¿ MIDDLEBROOK OADC ENRICHMENT

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code PPM·September 3, 2025

BD BBL¿ MIDDLEBROOK OADC ENRICHMENT

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code PPM·September 3, 2025

BD BBL¿ MIDDLEBROOK OADC ENRICHMENT

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code PPM·September 3, 2025

BD BBL¿ MIDDLEBROOK OADC ENRICHMENT

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code PPM·September 2, 2025

BD BBL¿ MIDDLEBROOK OADC ENRICHMENT

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code PPM·September 2, 2025

BD BBL¿ MIDDLEBROOK OADC ENRICHMENT

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code PPM·September 3, 2025

BD BBL¿ MIDDLEBROOK OADC ENRICHMENT

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code PPM·September 2, 2025