15 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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SHERLOCK 3CG TIP POSITIONING SYSTEM, SHERLOCK 3CG TIP POSITIONING SYSTEM STYLET
FDA 510(k)
FDA Class 2
·General Hospital
MICTEC OVAL TROCAR
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896007901·MICTEC OVAL TROCAR FOR ENDO STAPLER SMOOTH
DUFNER Instrumente GmbH
FDA UDI
DUFNER - Instrumente GmbH Fabrik ärztlicher Instrumente Medizintechnik·04063763199899·MICTEC Ovaltrocar for endo-stapler, smooth, Ø 1...
MICTEC OVAL TROCAR
FDA UDI
SONTEC INSTRUMENTS, INC.·B09920913240·MICTEC OVAL TROCAR FOR ENDO STAPLER SMOOTH
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450449455·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450464052·
SYNAMPS (32-64 CHANNELS), ESI SYNAMPS (65-128 CHANNELS), ESI SYNAMPS (129-256 CHANNELS)
FDA 510(k)
FDA Class 2
·Neurology
CAMBRIDGE HEART MODEL CH 2000 CARDIAC DIAGNOSTIC SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 17, 2025
DPM 4 MONITOR
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013
GRANUFLO
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 5, 2014
RESERVOIR 3CC
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code FRN·May 4, 2011
SINGLE USE BIOPSY VALVE (STERILE)
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT·Product code EOQ·July 26, 2021
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020