176 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Prosthesis, Spinous Process Spacer/Plate
FDA Pre-Market Approval
FDA Class 3
·DIAM Spinal Stabilization System
Prosthesis, Spinous Process Spacer/Plate
FDA Pre-Market Approval
FDA Class 3
·DIAM Spinal Stabilization System
ENDO
FDA UDI
SIRONA Dental Systems GmbH·E27662400430·Tulsa 6:1
LCP
FDA UDI
Synthes GmbH·10886982164575·4.5MM LCP PROXIMAL TIBIA PLATE 10 HOLES/190MM-LEFT
PILLING
FDA UDI
TELEFLEX INCORPORATED·14026704799302·
Bernafon
FDA UDI
Sbo Hearing A/S·05714464052363·ALPHA 9 FW 1.3.0
Gyrus ACMI
FDA UDI
Gyrus ACMI, LLC·00821925032118·PAPARELLA-TYPE VENT TUBE W/O TAB 1 MM I.D. SILI...
Protect U Guard Tie On Face Mask 3 Ply Green
FDA UDI
PROTECT U GUARD, LLC·B086200432·
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036035907·
Trial BiPolar Head
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215045487·
EVOLUTION® Hinge Knee System;GUARDIAN limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial Inse
FDA 510(k)
FDA Class 2
·Orthopedic
GORE TAG THORACIC ENDOPROSTHESIS
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code MIH·May 14, 2021
CONFORMABLE GORE TAGTHORACIC ENDOPROSTHESIS
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code MIH·December 14, 2020
GORE® EXCLUDER®AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code MIH·June 27, 2022
TENDRIL SDX
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·September 8, 2011
CELL-DYN WBC REAGENT A
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKZ·November 24, 2008
HOMECHOICE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·July 22, 2013
CONFORMABLE GORE TAGTHORACIC ENDOPROSTHESIS
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code MIH·May 3, 2021
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·GORE TAG THORACIC ENDOPROSTHESIS
System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection
FDA Pre-Market Approval
FDA Class 3
·Multi-Target Stool DNA (mtsDNA) Test, Cologuard Plus