15 results · 20ms · Sources: EU EUDAMED, US FDA

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BD Angiocath IV Catheter, BD Insyte IV Catheter

FDA 510(k)
FDA Class 2 ·General Hospital

BD ANGIOCATH¿ IV CATHETER

FDA Adverse Event
Malfunction ·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·December 19, 2017

BD ANGIOCATH IV CATHETER 20GA 1.88IN

FDA Adverse Event
Malfunction ·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·June 24, 2020

BD INSYTE¿ PERIPHERAL VENOUS CATHETER

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FOZ·March 20, 2018

Ophthalmic Speculum

FDA UDI
KATENA PRODUCTS, INC.·00841668100653·KATENA DOUBLE-X SPECULUM SOLID

MERRIES UNI-OSTEO, MODEL CS30250-CS10102

FDA 510(k)
FDA Class 2 ·Orthopedic

PROFEMUR(R) E CEMENTLESS HIP STEM

FDA 510(k)
FDA Class 3 ·Orthopedic

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE REHABILITATION EQUIP·Product code CAW·October 8, 2014

SPRINT FIDELIS

FDA Adverse Event
Injury ·MPRI·Product code LWS·June 7, 2013

ENDOTAK RELIANCE

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code NVY·July 6, 2011

Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·March 20, 2013

SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·March 26, 2014

Precise Treatment Table. To be used as part of radiation therapy treatment process.

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·April 17, 2013

All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·March 12, 2014

Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024