18 results · 20ms · Sources: EU EUDAMED, US FDA

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ProMin Dental Desensitizing Gel

FDA 510(k)
FDA Class 2 ·Dental

Unity Total Knee System

FDA UDI
CORIN LTD·05056139233739·Unity ASC IM Rod

MaXcess

FDA UDI
Nuvasive, Inc.·00887517193650·MaXcess Access Blade, 60mm Left

MONOBLOC REAMER 6.0mm

FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665000740·

Integra® Miltex®

FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780424932·Integra® Miltex® Jackson Tracheal Bistoury 7", ...

NANO TECH AND SUPER NANO ACUPUNCTURE NEEDLES

FDA 510(k)
FDA Class 2 ·General Hospital

CLEARGUARD HD END CAP

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

Regatta Lateral System

FDA UDI
Seaspine Orthopedics Corporation·10889981158880·Lateral Implant, 23mm x 10mm x 60mm, 10 Deg

Regatta Lateral System

FDA UDI
Seaspine Orthopedics Corporation·10889981162177·Lateral Implant, 23mm x 10mm x 60mm, 15 Deg

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 20, 2025

Vu aPod™ - L

FDA UDI
Seaspine Orthopedics Corporation·10889981046675·LATERAL IMPLANT, WIDE, LORDOTIC, 10mm X 23mm X ...

FLO-GARD 6201 VOLUMETRIC INFUSION PUMP 2M8063,

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·November 17, 2008

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011

PLUM XLD 110V L.A.

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·July 12, 2013

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

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

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

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

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

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