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Johnson & Johnson

Biotech company in United States. FDA records under 9 spellings of its name, each linked to the record. See the Johnson & Johnson group view.

  • Group records: 5,631, 147 entities
  • 510(k) clearances: 4,129
  • Device recalls: 1,302
  • Drug applications: 180
  • Drug recalls: 12

Records by Year

Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Johnson & Johnson and its 146 subsidiaries

Latest Records

Newest first across sources; each opens the record
DateRecordSource
Sep 23, 2026IMAAVY (nipocalimab-aahu) Injection, 300 mg /1.62 mL (185 mg/mL) per single-dose vial, For Intravenous Infusion After Dilution, Rx only, ManClass II · Presence of particulate matter.Drug recalls
Sep 17, 2026HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)K254196 · GEI510(k) clearances
Jun 29, 2026Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825); Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657484); Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510826); Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657485)K254149 · OWQ510(k) clearances
Jun 25, 2026Coated VICRYL™ (Polyglactin 910) Plus Antibacterial SutureK253394 · GAM510(k) clearances
Jun 25, 2026VELYS™ Robotic-Assisted SolutionK260480 · OLO510(k) clearances
Jun 11, 2026MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemK254087 · KTT510(k) clearances
May 26, 2026CROSSNAV Navigation Enabled Instruments for Disc Preparation and InterbodyK254157 · OLO510(k) clearances
May 22, 2026DePuy ATTUNE™ Knee SystemK252887 · OIY510(k) clearances
May 18, 2026STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control DevicesK252047 · NEW510(k) clearances
Mar 6, 2026VELYS™ Hip NavigationK253551 · RadiologyAI-enabled devices
Feb 20, 2026CARTO™ 3 EP Navigation System V8.4K252972 · CardiovascularAI-enabled devices
Feb 6, 2026Untitled letter: TREMFYAOffice of Prescription Drug PromotionOPDP letters
Jul 18, 2025Warning letter: Sterility assurance, Complaint handling, Quality unitCDERWarning letters
Dec 13, 2024Complete response letter, BLA 761433UnapprovedComplete response letters
Sep 7, 2023CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)K231207 · CardiovascularAI-enabled devices
May 3, 2023Warning letter: Medical DevicesCDRHWarning letters
Mar 18, 2019Warning letter: 510(k) requiredCDRHWarning letters
May 15, 2015Cell Search Circulating Tumor Kit. Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in whole blood.Class II · Complaints of the presence of artifacts that appears as small bead like structures in the image gallery when processing Device recalls
Jan 8, 2014CELLTRACKS ANALYZER II¿ (Product Code 9555) Product Usage: The CELLTRACKS ANALYZER II¿ is a semi-automated fluorescence microscope, coClass II · Janssen Diagnostics, LLC received complaints of camera failures on the CELLTRACKS ANALYZER II¿.Device recalls
Dec 28, 2012CELLTRACKS AUTOPREP System (Software Version 2.4.1 & Below. Product Usage: The CELLTRACKS AUTOPREP System is a general purpose laboratClass II · Veridex, LLC has received a report that a patient's demographics were incorrectly associated with another patient's idenDevice recalls
Dec 28, 2012CELLTRACKS ANALYZER II (Software Version 2.5.1 & Below. Product Usage: The CELLTRACKS AUTOPREP System is a general purpose laboratory Class II · Veridex, LLC has received a report that a patient's demographics were incorrectly associated with another patient's idenDevice recalls

Subsidiaries and Divisions

The 60 with the most records, of 146 subsidiaries in the Johnson & Johnson group, which counts 147 entities with Johnson & Johnson itself

Canada and Imports

Across the Johnson & Johnson group, matched by company name
Active Health Canada device licences
959, as of Nov 10, 2026
FDA import refusals since 2024
112 shipment lines, through Oct 23, 2026

Names and Identifiers

Appears as
JANSSEN BIOTECHJohnson & JohnsonJOHNSON AND JOHNSONJohnson & Johnson CompanyJohnson and JohnsonJanssen Biotech, Inc.Johnson & Johnson Co.
Website
jnj.com

Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built

Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.