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