16 results · 18ms · Sources: EU EUDAMED, US FDA

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NURSERY AMBIENT LIGHT METER

FDA 510(k)
FDA Class 2 ·General Hospital

JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 14 OTW

FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955930669·Percutaneous Transluminal Angioplasty Balloon C...

JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 14 OTW

FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955931765·Percutaneous Transluminal Angioplasty Balloon C...

JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 14 OTW

FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955932861·Percutaneous Transluminal Angioplasty Balloon C...

N.A.

FDA UDI
DENTAURUM GmbH & Co.KG·J011860120000·Standard Band, Tooth 15-14/24-25, Size 20

N.A.

FDA UDI
DENTAURUM GmbH & Co.KG·J011860120220·Standard Band, Tooth 15-14/24-25, Size 20/Roth 22

ORTHOMED

FDA UDI
ORTHO-MED, INC.·B8038601200·RIGHT ANGLED HOHMANN RETRACTOR 9 3/4"

N.A.

FDA UDI
DENTAURUM GmbH & Co.KG·J011860120180·Standard Band, Tooth 15-14/24-25, Size 20/Roth 18

TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

D-SPECT Processing and Reviewing Workstation

FDA 510(k)
FDA Class 2 ·Radiology

PULSE GENERATOR, PERMANENT, IMPLANTABLE

FDA Adverse Event
Malfunction ·MEDTRONIC, INC.·Product code NVZ·June 10, 2014

VASOVIEW HEMOPRO, OUS

FDA Adverse Event
Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code GEI·November 21, 2012

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 21, 2010

Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx30mm-Low Profile Titanium, Accessory to total hip implant Item Number: 103533 Product Usage: Accessory to total hip implant

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·April 10, 2019

Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·October 1, 2025

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