45 results · 21ms · Sources: EU EUDAMED, US FDA

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NP1 Instrument, Creo Electrosurgical System

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Paradigm

FDA UDI
Proprio, Inc.·00850042604052·Paradigm Blunt Probe

ReLine

FDA UDI
Nuvasive, Inc.·00195377045263·RELINE-O Trial, 7mm H Lamina N L-pop

ThinPrep®

FDA UDI
Hologic, Inc.·15420045508408·CytoLyt® Solution for use as a cell wash and tr...

OptumSI Implant System

FDA UDI
SI Solutions, LLC·00850057247039·Exchange Guide Pin

MicroAire®

FDA UDI
Microaire Surgical Instruments LLC·00847399000835·SMALL SAGITTAL SAW BLADE, 12.7mm X 24.3mm X 0.5mm

ARKEO, Wedge Fixation System

FDA UDI
Auxano Medical LLC·00810199190211·The ARKEO Wedge Fixation System (Preliminary Ki...

JEWELERS PRECISION FORCEPS

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896059337·JEWELERS PRECISION FORCEPS ANGLED TIPS #5 SERRA...

Lapiplasty SpeedPlate

FDA UDI
Treace Medical Concepts, Inc.·00810111221221·Inserter Cap

OsteoMed

FDA UDI
OSTEOMED LLC·00845694005579·1.6mm Pilot Drill, J-Latch

MICROETCHER

FDA UDI
DANVILLE MATERIALS, LLC·00816594021570·MICROETCHER II,JETLESS

Optoacoustic Imaging System

FDA Pre-Market Approval
FDA Class 3 ·Imagio Breast Imaging System

Clarius Ultrasound Scanner

FDA UDI
Clarius Mobile Health Corp·07540205000540·Clarius brand C3-45 scanner

OsteoMed

FDA UDI
OSTEOMED LLC·00845694066143·2.0 System 1.6mm Pilot Drill J-Latch Sterile Qty 2

ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE

FDA 510(k)
FDA Class 2 ·Cardiovascular

TORNIER TOTAL ELBOW PROSTHESIS

FDA 510(k)
FDA Class 2 ·Orthopedic

Optoacoustic Imaging System

FDA Pre-Market Approval
FDA Class 3 ·Imagio® Breast Imaging system

SOFTFORM FACIAL IMPLANT

FDA Adverse Event
Injury ·TISSUE TECHNOLOGIES, INC.·Product code FTL·June 27, 2000

RESTORE ULTRA

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·August 31, 2016

HEART START XL

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·January 22, 2013