16 results
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34ms
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Sources: EU EUDAMED, US FDA
KEELER KONAN SPECULAR MICROSCOPE SP3300
FDA 510(k)
FDA Class 2
·Ophthalmic
ReLine
FDA UDI
Nuvasive, Inc.·00195377067944·RELINE C Connector, 11mm Offset Open
3M™ Unitek™
FDA UDI
3M COMPANY·30605861026957·3M™ Unitek™ Stainless Steel First Primary Molar...
Barricade Coil System
FDA UDI
BALT USA LLC·00818053021107·Barricade Coil System (BCS) is intended for the...
Master Series
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746098987·DB BKT MASTER UL CUSP 018 T-2 A+10 R4M
Master Series
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746097003·DB BRACKET MASTER SERIES IBD MAND RIGHT CUSPID ...
CONLIN MOLAR BAND
FDA UDI
Ortho Arch Company Inc·D9099001111·MOLAR BAND CONLIN RX UPPER RIGHT 34
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
Embozene®
FDA UDI
BOSTON SCIENTIFIC CORPORATION·08714729943501·Microspheres for Embolization
NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
FLEXPEN NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
Intervertebral Body Fusion Device
FDA UDI
PRECISION SPINE, INC.·00840019922807·Shaver 11mm
NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code HRS·April 4, 2023
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·May 28, 2014
4.5MM LCP CONDYLAR PLATE 12 HOLES/278MM-RIGHT
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HRS·November 10, 2010
5MM, 33CM DORSEY GRASPER
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY SAN JOSE·Product code KOG·December 27, 2012