18 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPS
FDA 510(k)
FDA Class 2
·Dental
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810057372223·SKYTRON TRANSFER BOARD COVER
Symmetry Malis®
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482139790·Symmetry® Forceps; Bayonet Bipolar; 1.5 mm Tips...
Novo Surgical
FDA UDI
NOVO SURGICAL, INC.·00842331118920·MALIS Non-Stick Mirror Finish Bipolar Forceps, ...
Symmetry Olsen
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00841785112805·
Disposable Cuff
FDA UDI
SUNTECH MEDICAL, INC.·10840935105305·
REAL PATIENT WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS-RP (PROPOSED)
FDA 510(k)
FDA Class 2
·Neurology
SYNTHES 4.0 AND 5.0 MM LOCKING SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
SKYTRON PATIENT POSITIONER
FDA Adverse Event
Injury
·SCHUERCH CORPORATION·Product code FWZ·March 6, 2024
WAVEWRITER ALPHA? PRIME 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·April 28, 2026
22 G X 1.00 IN. BD INSYTE-W¿ PERIPHERAL VENOUS CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·September 8, 2017
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·April 26, 2013
7F PEDI CATH LAB INTRODUCER
FDA Adverse Event
Malfunction
·ARGON MEDICAL DEVICE, INC.·Product code DRE·April 6, 2011
OLYMPUS
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code FDI·July 17, 2008
BD INTIMA-II 24GAX0.75IN
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·November 1, 2023
2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·November 30, 2016
Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014