13 results · 19ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

ENZYMUN TEST TBG

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

K2-HF DENTINE, D-B4, 50g.

FDA UDI
Yeti Dentalprodukte GmbH·EYET38621090·

Shoreline™ ACS

FDA UDI
Seaspine Orthopedics Corporation·10889981177416·Modular Trial, 14 x 13 x 9mm, 10 Deg Lordosis

N.A.

FDA UDI
DENTAURUM GmbH & Co.KG·J011862109180·Standard Band, Tooth 45/35, Size 9/Roth 18

N.A.

FDA UDI
DENTAURUM GmbH & Co.KG·J011862109220·Standard Band, Tooth 45/35, Size 9/Roth 22

Kwart Retro-Inject Ureteral Stent

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

BINAXNOW INFLUENZA A & B TEST

FDA 510(k)
FDA Class 2 ·Microbiology

COBAS INTEGRA 400 PLUS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·October 7, 2025

SPRINT QUATTRO SECURE

FDA Adverse Event
Injury ·MPRI·Product code NVY·June 10, 2014

SWEET PICOTIP

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code NVN·October 8, 2010

LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

FDA Adverse Event
Malfunction ·ALLERGAN·Product code LTI·November 29, 2012

ESSURE

FDA Adverse Event
Injury ·BAYER PHARMA AG·Product code HHS·January 16, 2020

OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

FDA Enforcement
Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012