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