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

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IMAGE-ARENA APPLICATIONS, MODEL IMAGE-ARENA VA PLATFORM 1.0, 4D LV-ANALYSIS 2.5, 4D LV-ANALYSIS MR 1.0

FDA 510(k)
FDA Class 2 ·Radiology

Malecot

FDA UDI
COOK INCORPORATED·00827002145016·Malecot Nephrostomy Catheter/Stent Set

Millennium

FDA UDI
Avalign Technologies, Inc.·00190776095482·Teardrop SuctionTube,Tapered

LEONE SPA

FDA UDI
LEONE SPA·08033707067504·LIGATING MODULES 1 mm TRANSPARENT

Audit MicroControls Control FLQ Vitamin D

FDA UDI
AALTO SCIENTIFIC·B085K082M100·

MODIFICATION TO: LIFEMATE HEMOFILTRATION SYSTEM

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

SMARTLENS

FDA 510(k)
FDA Class 2 ·Ophthalmic

ROUND FILTERS W/INDICATOR

FDA Adverse Event
Malfunction ·SPS MEDICAL·Product code FRG·February 28, 2014

STARDRIVE SCREWDRIVER SHAFT QC/T15

FDA Adverse Event
Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HXX·April 9, 2019

STERITITE Containers: STERITITE Container Kit, 1/4 size, 3" high, product code: 13902; STERITITE Mini Mid Size, 3" high, product code: 13903; STERITITE Container Kit, 1/2 size, 4" high, product code: 13904; STERITITE Container Kit, 3/4 size, 4" high, product code: 13905; STERITITE Container Kit, Full size, 4" high, product code: 13906. The ASP STERITITE sealed container system provides an efficient and cost-effective way to package and protect surgical instruments for sterilization, transportation, storage, and aseptic presentation of contents.

FDA Enforcement
Class III ·Terminated·Advanced Sterilization Products·December 11, 2013

PAXGENE® BLOOD RNA TUBE

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code NTW·May 1, 2026

UPHOLD VAGINAL SUPPORT SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 29, 2013

TEVADAPTOR

FDA Adverse Event
Malfunction ·B BRAUN MEDICAL·Product code LHI·May 3, 2011

STERRAD 100S STERILIZER

FDA Adverse Event
Malfunction ·ADVANCED STERILIZATION PRODUCTS·Product code MLR·July 24, 2008

UNSPECIFIED BD PAXGENE® BLOOD TUBE

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code PJE·June 13, 2025

PAXGENE® BLOOD RNA TUBE

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code NTW·March 23, 2026

PAXGENE® BLOOD RNA TUBE

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code NTW·March 31, 2026

PAXGENE® BLOOD RNA TUBE

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code NTW·February 9, 2026

LOM Disposable Surgical Gowns/Medical Gowns, Single-Use

FDA Recall
Open, Classified ·THREAD COUNSEL INC DBA LAWS OF MOTION·Product code FYA·September 17, 2020

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014