15 results · 21ms · Sources: EU EUDAMED, US FDA

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Oral Surgery System and Accessories

FDA 510(k)
FDA Class 2 ·Dental

Simpact Tri-Fin

FDA UDI
Life Spine, Inc.·00190837062774·Cannulated Awl, 2.5mm

ENDURANCE

FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295057291·FEMORAL STEM 12/14 TAPER ENDURANCE HIP STEM SIZ...

CARBONAID GAS DIFFUSER

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

PATIENT-SPECIFIC VANGUARD FEMORAL COMPONETS

FDA 510(k)
FDA Class 2 ·Orthopedic

METRIX AIR

FDA Adverse Event
Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·August 21, 2019

PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

FDA Adverse Event
Injury ·MEDTRONIC MILACA, INC.·Product code LWP·June 7, 2013

ACCU-CHEK ® AVIVA TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 7, 2011

VERSACARE

FDA Adverse Event
Malfunction ·HILL-ROM RITTER·Product code FNL·September 10, 2008

LOGIC CR TIB INSERT STD, SZ 5, 9MM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·August 31, 2023

TR BAND

FDA Adverse Event
Malfunction ·TERUMO MEDICAL CORPORATION·Product code DXC·May 26, 2023

TR BAND

FDA Adverse Event
Malfunction ·TERUMO MEDICAL CORPORATION·Product code DXC·May 26, 2023

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

Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity CT

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·July 7, 2021

Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

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