486 results · 31ms · Sources: EU EUDAMED, US FDA

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INSULATION TESTER

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

KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 3 / Child ClearSeal Flexible King LAD¿ Patient Size: 30-50kg " Product Usage: Laryngeal airway

FDA Enforcement
Class II ·Terminated·King Systems Corp.·November 28, 2012

ATLANTIS® Anterior Cervical Plate System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994235121·SCREW 3120416 4.0 X 16 SELF DRILL FIX

ATLANTIS® Anterior Cervical Plate System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000889098·SCREW 3120416 4.0 X 16 SELF DRILL FIX

Unity Total Knee System

FDA UDI
CORIN LTD·05056139243936·UNITY KNEE™ PS-C INSERT - Size 4 x 16mm

NA

FDA UDI
Stryker Leibinger GmbH & Co. KG·04546540491688·BONE SCREW, CROSS-PIN, SELF-TAPPING

APEX PS Knee

FDA UDI
Omni Life Science, Inc.·00841690113256·PS Insert, Size 4 x 16mm

ABL835 FLEX ANALYZER WITH PLEURAL PH

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

BD GENEOHM VANR ASSAY

FDA 510(k)
FDA Class 2 ·Microbiology

ID NOW COVID-19

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·August 2, 2020

ID NOW COVID-19

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·August 2, 2020

ID NOW COVID-19

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·August 2, 2020

ID NOW COVID-19

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·August 2, 2020

ID NOW COVID-19

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·July 20, 2020

GMK SPHERE TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 23, 2025

GMK-SPHERE PATELLA RESURFACING SIZE 2

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·June 25, 2024

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T4-I3 R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 14, 2019

GMK SPHERE TOTAL KNEE SYSTEM

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code JWH·November 21, 2025

GMK SPHERE FEMORAL COMPONENT SIZE 4 LEFT

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 3, 2016

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·June 22, 2021