17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CALPREST
FDA 510(k)
FDA Class 2
·Immunology
A.S.A.P.® Indirect+ Extraoral/HP Disc Adjuster Refill
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172017008·Dental Abrasive Disk
A.S.A.P.® Indirect+ Extraoral/HP Disc Adjuster Refill
FDA UDI
DEN-MAT HOLDINGS, LLC·00359883006143·Dental Abrasive Disk
OsteoMed
FDA UDI
OSTEOMED LLC·00845694045988·PrimaLIF LLIF PEEK Implant, 9mm X 22mm X 45mm, ...
LINK Instruments - Rasps, compressors and broaches
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575286560·Orthopaedic prosthesis instrument, reusable - G...
POWDER-FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
FUSE PLIF CAFE
FDA 510(k)
FDA Class 2
·Orthopedic
SET, ADMINISTRATION, INTRAVASCULAR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·June 6, 2016
BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·May 16, 2018
STOPCOCK MANIFOLD GANGS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FMG·June 17, 2020
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 24, 2013
ADAPTA DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NVZ·June 16, 2011
IDC - INTERLOCKING DETACHABLE COIL
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code KRD·August 21, 2008
OSSEOTITE TAPERED CERTAIN PREVAIL IMPLANT 4/3 X 13MM
FDA Adverse Event
Injury
·BIOMET 3I·Product code DZE·September 29, 2025
Single Shot Epidural Tray Catalog Number: 8417
FDA Enforcement
Class II
·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022
Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018