Decisions47
Applicants28
47 premarket notifications (510(k)s) from applicants based in New Jersey were decided by FDA in the last 12 months, newest first. Each row links to FDA's own record.
| Decided | Applicant | Device | Area | Where | Record |
|---|---|---|---|---|---|
| 2026-09-24 | Diagnostica Stago, Inc. | STA® - Liquid Anti-Xa KFF | Hematology | Parsippany, New Jersey | K260214 |
| 2026-09-11 | Bio Compression Systems, Inc. | Sequential Circulator (SC-4004-DL, SC-4008-DL) JOW | Cardiovascular | Moonachie, New Jersey | K261807 |
| 2026-09-08 | B-One Ortho, Corp. | b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions JWH | Orthopedic | Cedar Knolls, New Jersey | K262341 |
| 2026-08-21 | Zeus Scientific | Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM MOB | Immunology | Branchburg, New Jersey | K261466 |
| 2026-08-06 | Howmedica Osteonics Corp. dba Stryker Orthopaedics | Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System KRO | Orthopedic | Mahwah, New Jersey | K261898 |
| 2026-07-17 | Stryker Spine | Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEM ODP | Orthopedic | Allendale, New Jersey | K262061 |
| 2026-07-13 | embecta Medical II, LLC | Ultra-Fine SAFETY Insulin Syringe FMF | General Hospital | Parsippany, New Jersey | K260208 |
| 2026-07-10 | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar Component LPH | Orthopedic | Mahwah, New Jersey | K261624 |
| 2026-07-07 | Mirion Technologies (Capintec), Inc. | Pulmonex II Xenon System (132-503) IYT | Radiology | Florham Park, New Jersey | K253942 |
| 2026-06-26 | Abbott Point of Care, Inc. | i-STAT Crea cartridge with the i-STAT 1 System CGL | Clinical Chemistry | Princeton, New Jersey | K261039 |
| 2026-06-25 | ETHICON, Inc. | Coated VICRYL (Polyglactin 910) Plus Antibacterial Suture GAM | General, Plastic Surgery | Raritan, New Jersey | K253394 |
| 2026-06-11 | Abbott Point of Care, Inc. | i-STAT hs-TnI cartridge with the i-STAT Alinity System MMI | Clinical Chemistry | Princeton, New Jersey | K253051 |
| 2026-06-08 | Onkos Surgical, Inc. | ELEOS with NanoCept® Technology Limb Salvage System QZZ | Orthopedic | Parsippany, New Jersey | K253066 |
| 2026-06-03 | Case Medical, Inc. | SteriTite Container System with MediTray Products KCT | General Hospital | Bloomfield, New Jersey | K252854 |
| 2026-05-18 | ETHICON, Inc. | STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices NEW | General, Plastic Surgery | Raritan, New Jersey | K252047 |
| 2026-05-15 | Organon, LLC | Jada System (Jada-2002) OQY | Obstetrics/Gynecology | Jersey City, New Jersey | K253642 |
| 2026-05-08 | Zeus Scientific | Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB OBE | Immunology | Branchburg, New Jersey | K250814 |
| 2026-04-27 | Maquet Cardiovascular, LLC | Fusion Bioline Vascular Graft DSY | Cardiovascular | Wayne, New Jersey | K252445 |
| 2026-04-27 | Diagnostica Stago, Inc. | STA Satellite Max® JPA | Hematology | Parsippany, New Jersey | K253658 |
| 2026-04-24 | Stryker Spine | Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute; Vitoss BBTrauma® Bioactive Bone Graft Substitute; Vitoss® BA2X Bioactive Bone Graft Substitute; Vitoss® Bioactive Foam Bone Graft Substitute Pack; Vitoss® Bioactive Foam Bone Graft Substitute; Vitoss® Foam Bone Graft Substitute; Vitoss® Bone Graft Substitute Filled Canister; Vitoss® Bone Graft Substitute MQV | Orthopedic | Allendale, New Jersey | K261008 |
| 2026-04-21 | RhythMedix, LLC | RhythmStar System (SL) QYX | Cardiovascular | Mt. Laurel, New Jersey | K250793 |
| 2026-04-15 | Becton, Dickinson and Company | BD Preset and BD A-Line Arterial Blood Collection Syringes JKA | Clinical Chemistry | Franklin Lakes, New Jersey | K260128 |
| 2026-04-13 | B-One Ortho, Corp. | b-ONE® Bipolar Head KWY | Orthopedic | Cedar Knolls, New Jersey | K253357 |
| 2026-04-10 | Becton, Dickinson and Company | BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood Collection Tube JKA | Clinical Chemistry | Franklin Lakes, New Jersey | K252378 |
| 2026-04-10 | Becton, Dickinson and Company | BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder JKA | Clinical Chemistry | Franklin Lakes, New Jersey | K252506 |
| 2026-03-27 | ETHICON, Inc. | STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX Spiral PRONOVA Bidirectional Knotless Tissue Control Device GAW | General, Plastic Surgery | Raritan, New Jersey | K253572 |
| 2026-03-20 | Liviwell, Inc. | Livi Device HEB | Obstetrics/Gynecology | Mountain Lakes, New Jersey | K252005 |
| 2026-03-13 | Becton, Dickinson and Company | BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood Collection Tubes JKA | Clinical Chemistry | Franklin Lakes, New Jersey | K252040 |
| 2026-02-20 | Soterix Medical, Inc. | SPRY TMS Therapy System (0550) OBP | Neurology | Woodbridge, New Jersey | K251653 |
| 2026-02-19 | AS Software, LLC | AS Software Version Asera LLZ | Radiology | Englewood Cliffs, New Jersey | K260205 |
| 2026-02-18 | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert MBH | Orthopedic | Mahwah, New Jersey | K253637 |
| 2026-02-06 | ETHICON, Inc. | MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture GAM | General, Plastic Surgery | Raritan, New Jersey | K253852 |
| 2026-01-28 | Koru Medical Systems, Inc. | FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing FRN | General Hospital | Mahwah, New Jersey | K252015 |
| 2026-01-15 | Nano-Ditech Corporation | Nano-Check Influenza A+B Test PSZ | Microbiology | Cranbury, New Jersey | K252283 |
| 2025-12-22 | ETHICON, Inc. | STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device GAM | General, Plastic Surgery | Raritan, New Jersey | K252743 |
| 2025-12-19 | Unipack, LLC | Chiavaye Personal Moisturizer NUC | Obstetrics/Gynecology | South Plainfield, New Jersey | K251011 |
| 2025-12-16 | Pentax of America, Inc. | PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family) FDS | Gastroenterology, Urology | Montvale, New Jersey | K251256 |
| 2025-12-15 | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper KRO | Orthopedic | Mahwah, New Jersey | K252898 |
| 2025-12-12 | Bio Compression Systems, Inc. | Bio Arterial Deluxe (IC-BAP-DX) JOW | Cardiovascular | Moonachie, New Jersey | K250974 |
| 2025-12-04 | Siemens Healthcare Diagnostics, Inc. | ADVIA Centaur Anti-Thyroglobulin II (aTgII) JNL | Immunology | Tarrytown, New Jersey | K250816 |
| 2025-12-02 | Becton, Dickinson and Company | 0.9 % Sodium Chloride Injection, USP, BD PosiFlush SP Syringe NGT | General Hospital | Franklin Lakes, New Jersey | K250884 |
| 2025-11-18 | Collagen Matrix, Inc. | Collagen Dura Regeneration Membrane - Repair GXQ | Neurology | Oakland, New Jersey | K251191 |
| 2025-11-14 | Princeton BioMeditech Corp. | Status COVID-19/Flu A&B SCA | Microbiology | Monmouth Junction, New Jersey | K251538 |
| 2025-11-12 | ETHICON, Inc. | PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture NEW | General, Plastic Surgery | Raritan, New Jersey | K243897 |
| 2025-10-24 | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Triathlon® Total Knee System - Triathlon® Gold Femoral Components MBH | Orthopedic | Mahwah, New Jersey | K252044 |
| 2025-10-22 | Zeus Scientific | Alegria Flash CTD Screen LLL | Immunology | Branchburg, New Jersey | K250666 |
| 2025-10-22 | Prosidyan, Inc. | FIBERGRAFT BG Putty GPS Bone Graft Substitute FIBERGRAFT BG Putty Bone Graft Substitute FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute FIBERGRAFT BG Matrix Bone Graft Substitute MQV | Orthopedic | New Providence, New Jersey | K253147 |
Where this comes from
Before most medical devices can be sold in the United States, the maker submits a premarket notification, a 510(k), and FDA decides whether the device is substantially equivalent to one already on the market. Every row here is one of those decisions, linked to FDA's own record of it. The product area is the medical specialty FDA files the device under; the location is the applicant's, as the submission gives it.
A clearance means the agency found the device substantially equivalent; it is not an endorsement. Where an applicant also files with the SEC under the same name in the same state, it links to that company's page.
Cite this page
Permanent URL:
https://mentionfox.com/fda/510k/state/njLast updated 2026-10-18
FDA device clearances in New Jersey: 47 510(k) decisions in the last 12 months. MentionFox, 2026-10-18. https://mentionfox.com/fda/510k/state/nj