3,439 results · 23ms · Sources: EU EUDAMED, US FDA

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EXALT Model B Single-Use Bronchoscope

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

Altus Spine Interbody Fusion System

FDA UDI
Altus Spine, LLC·00843210131634·Broach Trial

OsteoMed

FDA UDI
OSTEOMED LLC·00845694020824·FPS 2.0mm x 14mm Locking Screw

EVOS Lumbar Interbody System

FDA UDI
Cutting Edge Spine, LLC·00841193100142·EVOS Straight HA PEEK 14mm x 9mm x 22mm Biconve...

10M - General Purpose

FDA UDI
Certified Safety Manufacturing, Inc.·00766588020143·General Purpose - 10 Metal

OsteoMed

FDA UDI
OSTEOMED LLC·00845694075145·FPS 2.0 x 14mm Locking Screw Sterile Qty 5

Medical Nitrile Examination Gloves

FDA 510(k)
FDA Class 1 ·General Hospital

Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fit

FDA 510(k)
FDA Class 2 ·Radiology

PRECISION

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION.·Product code LGW·November 6, 2008

R SERIES DEFIBRILLATOR

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORP·Product code MKJ·August 17, 2011

ADVANCE BED

FDA Adverse Event
Malfunction ·HILL-ROM, INC.·Product code FNL·July 5, 2013

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

FDA Recall
Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·October 1, 2014

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·May 5, 2014

ANIMAS VIBE

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·November 5, 2014

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

FDA Enforcement
Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

ANIMAS VIBE

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·October 1, 2014

ANIMAS VIBE

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·November 5, 2014

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·January 15, 2015

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·May 2, 2014