75 results
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14ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Rapid Response Waste Management System Kit, REF BRC-BAL-INT-SL/B An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
FDA Enforcement
Class II
·Ongoing·Merit Medical Systems, Inc.·August 21, 2024
PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision System, for total knee arthroplasty procedures.
FDA Enforcement
Class II
·Terminated·Ortho Development Corporation·May 21, 2014
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, OXY/CVR COMBO BB841 FUSION W/BALANCE 26L, REF BB841. Used in Cardiopulmonary bypass.
FDA Enforcement
Class II
·Ongoing·Medtronic Perfusion Systems·February 8, 2023
"****ORTHO SENSOR**12-123-A Knee Trial for Trithion***1560 Saw grass Corporate Pkwy***4Th floor***Sunrise, FL 33323***www.orthosensor.com***" Rx Only*** Sterile/EO***Made exclusively for Stryker Orthopaedics***. Is the graphic user interface software associated with the graphic user interface, which is loaded onto the linkstations.
FDA Enforcement
Class II
·Terminated·Orthosensor·October 31, 2012
TRU-Balance 3 Power Positioning Systems, TB3 Lift/Tilt/Recline (Gen 1). Mobility Medical Device
FDA Enforcement
Class II
·Terminated·Pride Mobility Products Corp·January 11, 2017
Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
FDA Enforcement
Class II
·Ongoing·Medtronic Perfusion Systems·November 19, 2025
Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balanced heparin. Not for injection. , IVD, Rx Only, Sterile EO, CE
FDA Enforcement
Class II
·Ongoing·Radiometer Medical ApS·May 25, 2022
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in Cardiopulmonary bypass.
FDA Enforcement
Class II
·Ongoing·Medtronic Perfusion Systems·February 8, 2023
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB811. Used in Cardiopulmonary bypass.
FDA Enforcement
Class II
·Ongoing·Medtronic Perfusion Systems·February 8, 2023
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB841. Used in Cardiopulmonary bypass.
FDA Enforcement
Class II
·Ongoing·Medtronic Perfusion Systems·February 8, 2023
Atalante X, Powered Exoskeleton. Atalante X is intended to perform ambulatory functions and mobility exercises, hands-free, in rehabilitation institutions under the supervision of a trained operator.
FDA Enforcement
Class II
·Ongoing·WANDERCRAFT SAS·May 14, 2025
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 ¿L; Prepared with Balanced Heparin, Model/Catalog Number: 06 0187 Product Description: A clear, plastic capillary blood collection tube
FDA Enforcement
Class II
·Ongoing·ASP Global, LLC. dba Anatomy Supply Partners, LLC.·November 26, 2025
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 115 ¿L; Prepared with Balanced Heparin Model/Catalog Number: 06 0185 Product Description: A clear, plastic capillary blood collection tube
FDA Enforcement
Class II
·Ongoing·ASP Global, LLC. dba Anatomy Supply Partners, LLC.·November 26, 2025
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Prepared with Balanced Heparin Model 06 0186 Product Description: A clear, plastic capillary blood collection tube coated with Heparin
FDA Enforcement
Class II
·Ongoing·ASP Global, LLC. dba Anatomy Supply Partners, LLC.·November 26, 2025
Raindrop Near Vision Inlay, Model# RD1-1
FDA Enforcement
Class II
·Terminated·Revision Optics Inc·March 29, 2017
Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·April 13, 2022
Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 1 cc, with Eclipse, 25 g x 5/8" A Needle, 25U Balanced Heparin, part number: 3173-98. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.
FDA Enforcement
Class II
·Terminated·Westmed Inc·October 31, 2012
Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 1 cc, with Eclipse, 25 g x 5/8" A Needle, 25U Balanced Heparin, part number: 3165-98. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.
FDA Enforcement
Class II
·Terminated·Westmed Inc·October 31, 2012
Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, 23g x 1" A Needle w/Eclipse, 25U Balanced Heparin, No CE, part number: 3373-98. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.
FDA Enforcement
Class II
·Terminated·Westmed Inc·October 31, 2012
Philips Allura Xper FD20 Ceiling version only; 722028; imaging applications.
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·February 17, 2016