14 results
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34ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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STRUXXURE®-L and STRUXXURE®-A Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112816·BARRON VACUUM PUNCH 9.0MM
APEX Base - Original Pink - 3kg
FDA UDI
Sprintray, Inc.·00850070544429·SprintRay Apex Base resin is a light-curable po...
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112717·BARRON VACUUM PUNCH 6.5MM
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112878·CORNEAL TREPHINE BLADE6.5MM
PEGASUS NASAL CPAP SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
DERMAGUARD PF BROWN POWDER FREE LATEX SURGICAL GLOVES; MODEL STYLE 38
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ANGIOGUARD RX
FDA Adverse Event
Malfunction
·CORDIS CORPORATION·Product code NTE·October 16, 2008
SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·IDEV TECHNOLOGIES, INC.·Product code FGE·June 28, 2013
CAPSURE SP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011
BD EMERALD¿ SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·August 29, 2022
WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NGV·October 13, 2021
dS Breast 7ch 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 4, 2024
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