23 results · 29ms · Sources: EU EUDAMED, US FDA

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ARTERIOVENOUS FISTULA SETS

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

ReLine

FDA UDI
Nuvasive, Inc.·00195377067968·RELINE C Connector, 25mm Offset Open Lng

Clear Readers

FDA UDI
Diversified Products, Inc.·00037741290018·

Master Series

FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746097669·DB BRACKET MASTER SERIES IBD MAX RIGHT CUSPID 0...

Emergent Respiratory

FDA UDI
MDL Solutions Incorporated·00850071887167·Breathing Circuit with Large S3 Mask

Barricade Coil System

FDA UDI
BALT USA LLC·00818053021244·Barricade Coil System (BCS) is intended for the...

3M™ Unitek™

FDA UDI
3M COMPANY·30605861027176·3M™ Unitek™ Stainless Steel First Primary Molar...

MyndMove

FDA UDI
MyndTec Inc·00692520001256·

MyndMove

FDA UDI
MyndTec Inc·06925209001259·

Neuro Kinetics, Inc. (NKI) I-Portal¿ NOTC system with the OVAR research test; a rotary chair system used in vestibular and neuro-otologic diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.The OVAR test has not yet been cleared by the FDA, and until then can only be used as an investigational device.

FDA Enforcement
Class II ·Terminated·Neuro Kinetics, Inc.·September 9, 2015

CONLIN MOLAR BAND

FDA UDI
Ortho Arch Company Inc·D90990012514·MOLAR BAND CONLIN RX UPPER RIGHT 41

VISION SCIENCES FLEXIBLE ENT SCOPE

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

JET PORT PLUS CATHETER SYSTEM

FDA 510(k)
FDA Class 2 ·General Hospital

NA

FDA UDI
STRYKER CORPORATION·07613327643848·PIN COLLET

Stryker F1

FDA UDI
STRYKER CORPORATION·07613327072099·Charger Module

TCP

FDA UDI
WRIGHT MEDICAL TECHNOLOGY, INC.·00840420169525·

HNM MMEDICAL

FDA UDI
HNM STAINLESS, LLC.·00842962154298·LONG COBB ELEVATOR, 15", 3/4" WIDTH, 9" HANDLE

I-STAT CHEM8+ CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE·Product code JGS·March 30, 2023

EON

FDA Adverse Event
Injury ·ST JUDE MEDICAL -NEUROMODULATION·Product code GZB·May 28, 2014

MESHGRAFT II DERMATOME WITH RATCHET

FDA Adverse Event
Malfunction ·ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS·Product code GFD·October 22, 2010