19 results · 28ms · Sources: EU EUDAMED, US FDA

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AVIEW Modeler

FDA 510(k)
FDA Class 2 ·Radiology

Phasix

FDA UDI
Davol Inc.·00801741107634·Phasix Mesh, 8" x 16" (20 cm x 40 cm), Rectangle

Ceramco® II Silver™

FDA UDI
Dentsply International Inc.·D0011920400·

LMA AIRWAY MANAGEMENT

FDA UDI
TELEFLEX INCORPORATED·15060112319997·LMA Protector™ Cuff Pilot™ Size 4

LMA AIRWAY MANAGEMENT

FDA UDI
TELEFLEX INCORPORATED·15060112317986·LMA Protector™ Cuff Pilot™ Size 4

LMA AIRWAY MANAGEMENT

FDA UDI
TELEFLEX INCORPORATED·05060112313868·LMA Protector™ Cuff Pilot™ Size 4

OsteoMed

FDA UDI
OSTEOMED LLC·00845694015431·2.0mm x 40mm Cannulated Lag Screw

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B16741920400·

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B1674192040060·

OsteoMed

FDA UDI
OSTEOMED LLC·00845694070461·Cannulated 2.0 x 40mm Lag Screw Sterile Qty 2

PATIENT MONITOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

PHEROCIOUS 10.5 FR (24 CM, 28 CM AND 32 CM), MODELS 430102440, 430102840, 430103240

FDA 510(k)
FDA Class 2 ·General Hospital

AQUILEX FLUID CONTROL SYSTEM

FDA Adverse Event
Malfunction ·W.O.M. WORLD OF MEDICINE GMBH·Product code HIG·March 12, 2020

FREESTYLE LITE

FDA Adverse Event
Injury ·ABBOTT DIABETES CARE INC, USA·Product code LFR·October 7, 2008

OT ULTRAMINI METER

FDA Adverse Event
Injury ·LIFESCAN INC.·Product code NBW·August 4, 2011

EON MINI

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 20, 2013

ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025

Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.

FDA Enforcement
Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025