13 results · 20ms · Sources: EU EUDAMED, 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