170 results · 25ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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