14 results · 25ms · Sources: EU EUDAMED, US FDA

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1Derful HS, 1Derful HT

FDA 510(k)
FDA Class 2 ·Dental

POSIFLUSH

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·April 20, 2026

TITANIUM COMPRESSION ANCHOR SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

EASYFIT SILKGEL NASAL MASK

FDA 510(k)
FDA Class 2 ·Anesthesiology

BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·April 7, 2021

POSIFLUSH

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·May 1, 2026

BD POSIFLUSH

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code NGT·March 20, 2026

BD POSIFLUSH

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code NGT·March 20, 2026

POSIFLUSH

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FOZ·April 6, 2026

CB - X II DUAL - ENDED CLEANING BRUSH

FDA Adverse Event
Malfunction ·KIMBERLY CLARK GLOBAL SALES, INC.·Product code KNW·October 24, 2008

ACCESS® 2 IMMUNOASSAY SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code MMI·August 12, 2011

COGNIS

FDA Adverse Event
Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 8, 2013

EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.

FDA Enforcement
Class II ·Terminated·Olympus Corporation of the Americas·October 7, 2015

ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015