21 results
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20ms
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Sources: EU EUDAMED, US FDA
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