13 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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TruForm Sievers Annuloplasty Ring
FDA 510(k)
FDA Class 2
·Cardiovascular
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112885·CORNEAL TREPHINE BLADE6.75MM
Vilex Power Accessory
FDA UDI
VILEX IN TENNESSEE, INC.·00841731122308·KWire .078 x 9"(2.0x225mm))
Cadwell
FDA UDI
Technomed Engineering B.V.·08720791373184·Disposable Monopolar Needle Electrode, pre-wire...
Megadyne Telescoping Smoke Evacuation Pencil - 10ft tubing, Megadyne Telescoping Smoke Evacuation Pencil - 15ft tubing, Megadyne Telescoping Smoke Evacuation Soft Tissue Dissector, Megadyne Telescoping Soft Tissue Dissector
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ECHO BLASTER
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 29, 2025
OLYMPUS THUNDERBEAT 5 MM, 35 CM, PISTOL GRIP
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code GEI·June 28, 2013
CAPSUREFIX NOVUS MRI
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code NVN·August 11, 2011
OMNIPOD INSULIN PUMP
FDA Adverse Event
Injury
·INSULET CORPORATION·Product code LZG·October 15, 2014
BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·February 9, 2022
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 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