20 results · 14ms · Sources: EU EUDAMED, US FDA

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smith&nephew R3 THREE HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 40MM 71335540 42MM 71335542 44MM 71335544 46MM 71335546 48MM 71335548 50MM 71335550 52MM 71335552 54MM 71335554 56MM 71335556 58MM 71335558 60MM 71335560 Orthopedic implant component.

FDA Recall
Open, Classified ·Smith & Nephew, Inc.·Product code MBL·April 22, 2020

smith&nephew R3 THREE HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331942 46MM 71331946 48MM 71331948 50MM 71331950 52MM 71331952 54MM 71331954 56MM 71331956 58MM 71331958 60MM 71331960 62MM 71331962 64MM 71331964 68MM 71331968 Orthopedic implant component.

FDA Recall
Open, Classified ·Smith & Nephew, Inc.·Product code MBL·April 22, 2020

smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331842 48MM 71331848 50MM 71331850 52MM 71331852 54MM 71331854 56MM 71331856 58MM 71331858 60MM 71331860 Orthopedic implant component.

FDA Recall
Open, Classified ·Smith & Nephew, Inc.·Product code MBL·April 22, 2020

smith&nephew R3 ZERO HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71332242 46MM 71332246 48MM 71332248 50MM 71332250 52MM 71332252 54MM 71332254 56MM 71332256 58MM 71332258 60MM 71332260 62MM 71332262 64MM 71332264 Orthopedic implant component.

FDA Recall
Open, Classified ·Smith & Nephew, Inc.·Product code MBL·April 22, 2020

smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Sizes REF/product number 48MM 71338663 50MM 71338664 52MM 71338665 54MM 71338666 56MM 71338667 58MM 71338668 Orthopedic implant component.

FDA Recall
Open, Classified ·Smith & Nephew, Inc.·Product code MBL·April 22, 2020

smith&nephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 48MM 71338733 50MM 71338734 52MM 71338735 54MM 71338736 56MM 71338737 58MM 71338738 62MM 71338740 64MM 71338741 Orthopedic implant component.

FDA Recall
Open, Classified ·Smith & Nephew, Inc.·Product code MBL·April 22, 2020

Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit

FDA Recall
Open, Classified ·Bio-Rad Laboratories·Product code OYX·February 15, 2024

Brand Name: Xpert BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10

FDA Recall
Open, Classified ·Cepheid·Product code OYX·October 30, 2025

Brand Name: Xpert BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10

FDA Recall
Open, Classified ·Cepheid·Product code OYX·October 30, 2025

GE HealthCare CRITIKON ONE-CUF blood pressure cuffs, Model numbers: 1. ONE-A1-1B, ONE-CUF, SMALL ADULT, 1 TB BAYONET, 17 - 25 CM, 20/BOX; 2. ONE-A1-2A, ONE-CUF, SMALL ADULT, DINACLICK 80369-5, 17 - 25 CM, 20/BOX; 3. ONE-A2-1B, ONE-CUF, ADULT, 1 TB BAYONET, 23 - 33 CM, 20/BOX; 4. ONE-A1-1B-L, ONE-CUF, ADULT LONG, 1 TB BAYONET, 23 - 33 CM, 20/BOX; 5. ONEA2-2A, ONE-CUF, ADULT, DINACLICK 80369-5, 23 - 33 CM, 20/BOX; 6. ONE-A2-2A-L, ONE-CUF, ADULT LONG, DINACLICK 80369-5, 23 - 33 CM, 20/BOX; 7. ONE-A3-1B, ONE-CUF, LARGE ADULT, 1 TB BAYONET, 31 - 40 CM, 20/BOX; 8. ONE-A3-2A, ONE-CUF, LARGE ADULT, DINACLICK 80369-5, 31 - 40 CM, 20/BOX; 9. ONE-P1-1B, ONE-CUF, INFANT, 1 TB BAYONET, 08 - 13 CM, 20/BOX; 10. ONE-P1-2A, ONE-CUF, INFANT, DINACLICK 80369-5, 08 - 13 CM, , 20/BOX; 11. ONE-P2-1B, ONE-CUF, CHILD, 1 TB BAYONET, 12 - 19 CM, 20/BOX; and 12. ONE-P2-2A, ONE-CUF, CHILD, DINACLICK 80369-5, 12 - 19 CM, 20/BOX.

FDA Recall
Open, Classified ·GE Medical Systems Information Technologies Inc·Product code DXQ·April 9, 2024

Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001 Product Description: Common Name: Diagnostic intravascular catheter Description: The Novasight Hybrid catheter is a 3Fr single use, sterile device, which will be able to perform transluminal ultrasound and optical coherence tomography imaging of adults. The catheter is capable of real-time 2D side viewing ultrasound and optical imaging acquired simultaneously providing precisely co-registered images with the ability to produce rapidly post processed rendered longitudinal images of the vessel. Packaging: The Novasight Hybrid Catheter is packaged in a packaging system including the protective packaging and the sterile barrier system.

FDA Recall
Open, Classified ·Conavi Medical Inc.·Product code OBJ·March 12, 2025

1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. HeartMate Touch Communication System, HMT1150 The HeartMate Touch Application is loaded onto a tablet and will provide a user interface with state-of-the-art hardware/software platforms for supporting LVAD patients. Along with being able to program and monitor the LVAS, the HeartMate Touch Application introduces features that enables users to setup pairing and connection with the existing HeartMate 3 Left Ventricular Assist System (LVAS) via the HeartMate Touch Wireless Adapter and generate reports from the log files that are downloaded from the HM3 System Controller.

FDA Recall
Open, Classified ·Thoratec Corp.·Product code DSQ·January 3, 2024

AlternatiV+ Screw-In Anchor

FDA Recall
Open, Classified ·Aju Pharm Co., Ltd. Room 201, Room 207, Bl A Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang Seongnam Korea (the Republic of)·Product code MAI·December 17, 2025

Fixone Hybrid Anchor

FDA Recall
Open, Classified ·Aju Pharm Co., Ltd. Room 201, Room 207, Bl A Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang Seongnam Korea (the Republic of)·Product code MAI·December 17, 2025

Genesis Screw-In Anchor

FDA Recall
Open, Classified ·Aju Pharm Co., Ltd. Room 201, Room 207, Bl A Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang Seongnam Korea (the Republic of)·Product code MAI·December 17, 2025

Genesis Dual Thread Screw-In Anchor

FDA Recall
Open, Classified ·Aju Pharm Co., Ltd. Room 201, Room 207, Bl A Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang Seongnam Korea (the Republic of)·Product code MAI·December 17, 2025

AlternatiV+ Max Knotless Anchor

FDA Recall
Open, Classified ·Aju Pharm Co., Ltd. Room 201, Room 207, Bl A Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang Seongnam Korea (the Republic of)·Product code MAI·December 17, 2025

Fixone Biocomposite Anchor

FDA Recall
Open, Classified ·Aju Pharm Co., Ltd. Room 201, Room 207, Bl A Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang Seongnam Korea (the Republic of)·Product code MAI·December 17, 2025

Genesis Push-In Suture Anchor

FDA Recall
Open, Classified ·Aju Pharm Co., Ltd. Room 201, Room 207, Bl A Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang Seongnam Korea (the Republic of)·Product code MAI·December 17, 2025

Genesis Knotless Anchor

FDA Recall
Open, Classified ·Aju Pharm Co., Ltd. Room 201, Room 207, Bl A Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang Seongnam Korea (the Republic of)·Product code MAI·December 17, 2025