16 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP Adjustable Fixation System for Ligament Reconstruction, PULLUP TEX CLIP Adjustable Fixation System for Ligament Reconstruction, BT LOOP Adjustable Fixation System for Ligament Reconstruction
FDA 510(k)
FDA Class 2
·Orthopedic
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112724·BARRON VACUUM PUNCH 6.75MM
APEX Base - Dark Reddish Pink - 3kg
FDA UDI
Sprintray, Inc.·00850070544436·SprintRay Apex Base resin is a light-curable po...
LEONE SPA
FDA UDI
LEONE SPA·08033707037026·TWEED DB BRACKET 22 KIT
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112823·BARRON VACUUM PUNCH 9.25MM
TETRAD TC-C3-ACP
FDA 510(k)
FDA Class 2
·Radiology
DINAMAP PROCARE SERIES MONITOR, MODELS 100N, 200N, 300N, 400N
FDA 510(k)
FDA Class 2
·Cardiovascular
WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NGV·May 10, 2021
DINAMAP PROCARE SERIES MONITOR
FDA Adverse Event
Malfunction
·GE HEALTHCARE·Product code MWI·September 9, 2010
DINAMAP PROCARE SERIES MONITOR
FDA Adverse Event
Malfunction
·GE HEALTHCARE·Product code MHX·September 9, 2010
SMART CONTROL NITINOL STENT SYSTEM
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code NIO·October 16, 2008
ARTRICLIP GILLINOV-COSGROVE LAA EXCLUSION SYS.
FDA Adverse Event
Malfunction
·ATRICURE, INC.·Product code FZP·June 28, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 5, 2011
CONNECTING SCREW F/GUIDE WIRE AIMING DEVICE F/TFN
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code FZX·July 3, 2018
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
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021