16 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SPECULAR MICROSCOPE CEM-530
FDA 510(k)
FDA Class 2
·Ophthalmic
EVONOS GMBH & Co. Kg
FDA UDI
Gyrus ACMI, LLC·00821925013902·HOUSE-TYPE ROSEN NEEDLE, BLUNT
Biogel
FDA UDI
Bosma Enterprises·10818634023435·Biogel M Surgical 6.5 - 50 Pair/Box
Gyrus ACMI
FDA UDI
Provision·B504GS1305650·
MATHIEU NEEDLE HOLDER
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896075818·MATHIEU NEEDLE HOLDER HEAVY
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450116913·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450541708·
DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL 8900-0300, 8900-0325
FDA 510(k)
FDA Class 3
·Cardiovascular
MEDVOXEL HEARTPRO SOFTWARE APPLICATION
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 28, 2025
STANDARD STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM DE MEXICO S DE RL DE CV·Product code FPO·March 27, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·September 30, 2014
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code NVZ·June 16, 2011
Stereo Breast Biopsy Tray Catalog Number: 2383R1
FDA Enforcement
Class II
·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022
AMISTEM H, HA COATED STEM SIZE 6 LAT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 18, 2016
Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
FDA Enforcement
Class II
·Terminated·Senseonics, Inc.·November 6, 2019