13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ACUSON SC2000 Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776394714·Cushing-Kocher Retractor, 10x10mm blade, 7"
AVANOS
FDA UDI
Avanos Medical, Inc.·00193493929320·AVANOS* Nerve Block Trays
Halyard
FDA UDI
Avanos Medical, Inc.·10680651929324·HYH,NBT,NRVBLK,-,-,10
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515025004·Cushing-Kocher Retractor, 10x10mm blade, 7"
Integra® Miltex®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780463221·Kraff-Utrata Capsulorhexis Forceps, 4", Sharp
ENDOBUTTON CONTINUOUS LOOP (CL)
FDA 510(k)
FDA Class 2
·Orthopedic
REPLENS LONG-LASTING VAGINAL MOISTURIZER (35G TUBE WITH REUSABLE APPLICATOR) MODEL: 83035
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SCRDRIVER F/SYNFIX-LR
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HXX·June 20, 2013
ACUVUE OASYS BRAND WITH HYDRACLEAR PLUS
FDA Adverse Event
Injury
·VISTAKON·Product code LPM·July 22, 2011
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Death
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·October 17, 2014
CHROMID® CARBA SMART
FDA Adverse Event
Malfunction
·BIOMERIEUX S.A.·Product code JSO·August 23, 2018
Ingenia 1.5T S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Model: 781347
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021