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

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basixTOUCH40 Inflation Syringe

FDA 510(k)
FDA Class 2 ·Cardiovascular

Ophthalmic Speculum

FDA UDI
KATENA PRODUCTS, INC.·00841668100509·SELTZER SPECULUM FLAT K-WIRE

PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

REUSABLE PPH CIRCULAR STAPLER HANDLE, PPH CIRCULAR STAPLER RELOAD & ACCESSORY SET

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

INION OTPS BIOABSOBABLE FREEDOMPLATE

FDA Adverse Event
Injury ·INION OY·Product code HRS·November 18, 2014

INION OTPS BIOABSOBABLE FREEDOMPLATE

FDA Adverse Event
Injury ·INION OY·Product code HRS·May 14, 2015

INION OTPS BIOABSORBABLE FREEDOMPLATE

FDA Adverse Event
Injury ·INION OY·Product code HRS·March 19, 2015

RIATA ACTIVE FIXATION

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·October 8, 2014

CAPSUREFIX MRI SURESCAN

FDA Adverse Event
Injury ·MPRI·Product code NVN·June 8, 2013

ENDOTAK ENDURANCE

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code NVY·July 7, 2011

INION OTPS BIOABSORBABLE FREEDOMPLATE

FDA Adverse Event
Injury ·INION OY·Product code HRS·June 5, 2015

ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

FDA Enforcement
Class II ·Ongoing·Elekta, Inc.·December 13, 2023

Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

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

PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·October 25, 2017