24 results · 23ms · Sources: EU EUDAMED, US FDA

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DIGITAL DENTAL INTRA ORAL SENSOR, HDI 2000, HDI 2000A

FDA 510(k)
FDA Class 2 ·Radiology

Catheter and Glove Suction Kit

FDA UDI
C. R. Bard, Inc.·00801741050657·Catheter and Glove Suction Kit with Solution Co...

OsteoMed

FDA UDI
OSTEOMED LLC·00845694003544·Right Reconstruction Plate w/Angle

Mariner Outrigger

FDA UDI
Seaspine Orthopedics Corporation·10889981179632·Z-Rod, Dia. 6.0mm, Co-Cr, 60mm

BioCORE

FDA UDI
COLLAGEN MATRIX, INC.·00813954024752·Moldable Bioactive Graft, 32mm x 32mm

BioCORE

FDA UDI
COLLAGEN MATRIX, INC.·00813954024769·Moldable Bioactive Graft, 50mm x 20mm

EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

SONOLINE G50 AND G60 S DIAGNOSTIC ULTRASOUND SYSTEMS

FDA 510(k)
FDA Class 2 ·Radiology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·June 4, 2025

PCA INFUSOR

FDA Adverse Event
Injury ·IVAC MEDICAL SYSTEMS·Product code MEA·December 5, 1996

EQUINOXE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·August 26, 2019

EQUINOXE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·February 6, 2019

INSIGNIA

FDA Adverse Event
Injury ·GUIDANT CLONMEL IRELAND·Product code LWP·October 3, 2014

HUT EXT DR FINAL ASSY-STANDARD

FDA Adverse Event
Malfunction ·LIEBEL-FLARSHEIM CO.·Product code IXR·May 29, 2013

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·June 25, 2011

COMP RVRS SHLDR GLNSP STD 36MM

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code PAO·March 23, 2017

EQUINOXE SHOULDER COMPONENTS

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWS·January 9, 2024

ARCOM XL 44-36 STD HMRL BRNG

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code PAO·November 30, 2016

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

Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc. Oncology Systems·May 22, 2013