14 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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NUVASIVE NVM5 SYSTEM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
n/a
FDA UDI
HANS RUDOLPH, INC.·00874750006724·2700CB 2WAY NRBV W/BODY SALIVA
27mm x 12mm x 18mm TLIF with Inserter and Tamp
FDA UDI
XENCO MEDICAL LLC·B064XM01127181·27mm x 12mm x 18mm TLIF
DIGITAL THERMOMETER; DIGITAL THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
MODIFICATION TO COROMETRICS MODEL 120IS MATERNAL/FETAL MONITORING SYSTEM.
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 16, 2026
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 30, 2015
HP MBT CEM KEEL PUNCH SZ 4-7
FDA Adverse Event
Malfunction
·1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC·Product code LXH·September 24, 2014
ASR ACETABULAR CUPS 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD·Product code KWA·May 19, 2011
Alcon Custom Ophthalmic Surgical Procedure Packs
FDA Enforcement
Class II
·Terminated·Alcon Research, LLC·April 7, 2021
Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
FDA Enforcement
Class II
·Terminated·Senseonics, Inc.·November 6, 2019
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Enforcement
Class I
·Ongoing·Covidien·November 8, 2023
IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec AG·December 9, 2015
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021