170 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PLATO MICROCATH 27 MICROCATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Z Liquid ST B1-S 100ml
FDA UDI
ARGEN CORPORATION, THE·D818121734·Dental porcelain/ceramic restoration kit
Cup Forceps
FDA UDI
ELLIQUENCE, LLC·00846338002442·
MYSAFETY SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
VISIONSCOPE HIGH DEFINITION ENDOSCOPY CAMERA SYSTEM WITH; CAMERA CONTROL UNIT; CAMERA HANDPIECE; VISIONSCOPE ENDOSCOPES
FDA 510(k)
FDA Class 2
·Orthopedic
NOVOSYN QUICK UNDY 4/0(1,5)70CM DS16MDDP
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·January 24, 2020
ACCENT DR RF
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CARDIAC RHYTHM MANAGEMENT DIVISI·Product code DXY·January 13, 2014
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·May 21, 2013
GLUMA DESENSITIZER
FDA Adverse Event
Injury
·HERAEUS KULZER, GMBH·Product code KLE·May 26, 2011
NOVOSYN VIOLET 4/0 (1,5)45CM DS19 (M)RCP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·May 18, 2022
NOVOSYN VIOLET 4/0 (1,5)45CM DS19 (M)RCP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·May 27, 2022
NOVOSYN VIOLET 1 (4) 90CM HRT37S (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·May 13, 2019
BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·July 22, 2022
NOVOSYN VIOLET 0 (3.5) 70CM FR26 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·February 27, 2020
NOVOSYN QUICK UNDY 3/0(2)70CM DSMP19MDDP
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·August 28, 2019
NOVOSYN QUICK UNDY 3/0(2)70CM DSMP24MDDP
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·August 29, 2019
NOVOSYN QUICK UNDY 3/0(2)45CM DS24(M)DDP
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·April 3, 2019
NOVOSYN VIOLET 1 (4) 70CM HR26 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·September 11, 2019
NOVOSYN VIOLET 1 (4) 90CM HR37S (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·October 21, 2019
iVue with Normative Database, Device Listing Number D185549. Product Usage: The iVue (K121739) is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional, and three dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue with Normative Database is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVue with Normative Database is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population.
FDA Enforcement
Class II
·Terminated·Optovue, Inc.·September 6, 2017