16 results
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18ms
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Sources: EU EUDAMED, US FDA
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