Oct 30, 2026
K263860
Shining3D Clear Aligner System
Hangzhou SHINING3D Dental Technology Co., Ltd.
- NXC
- Class II
Latest FDA data: week of Nov 2 – Nov 8, 2026
Latest week in device regulation
510(k) clearances, device recalls, and device warning letters from public FDA records, newest first. openFDA publishes device clearances and recalls with a lag of one to three weeks, so this is the newest Monday–Sunday week in the archive that has any of those records. Warning letters come from FDA.gov. A category with nothing in that week shows its own latest week, and its count names that week.
- Clearances
- 95
- Recalls
- 75
- Letters
- 1
week of Oct 26 – Nov 1, 2026
Latest 510(k) clearances (week of Oct 26 – Nov 1, 2026)
See all 95 from this weekOct 30, 2026
K263592
da Vinci Xi Surgical System (IS4000);da Vinci X Surgical System (IS4200)
Intuitive Surgical, Inc.
- NAY
- Class II
Oct 30, 2026
K263587
Arctic Sun™ Neonatal ArcticGel™ Pad
Medivance, Inc.
- DWJ
- Class II
Oct 30, 2026
K263232
eplex RP3 Control M530; eplex RP3 Negative
Maine Molecular Quality Controls, Inc.
- PMN
- Class II
Oct 30, 2026
K263109
EFAI NEUROSUITE CTA LVO ASSESSMENT SYSTEM (LVO-CTA-100)
Ever Fortune.Ai, Co., Ltd.
- QAS
- Class II
Oct 30, 2026
K263076
AngioVac F1885
AngioDynamics, Inc.
- DWF
- Class II
Oct 30, 2026
K263075
Strauss Surgical Cystoscope/Hysteroscope and Accessories Instruments
Strauss Surgical USA
- FAJ
- Class II
Oct 30, 2026
K263063
B`orze Inc Laser Family (Sorren/Adonis)
Borze, Inc.
- GEX
- Class II
Oct 30, 2026
K262971
Xpert® Hemorrhagic Fever Panel
Cepheid
- QVR
- Class II
Oct 30, 2026
K262938
cobas eplex respiratory pathogen panel 3
GenMark Diagnostics, Inc.
- QOF
- Class II
Device recalls
See all 75 from this weekNov 5, 2026
Z-0359-2027
LIAISON PLEX Gram-Negative Blood Culture Assay Catalog No. 20-005-303
Luminex Corporation
- NSU
- Class II
- Open, Classified
Nov 5, 2026
Z-0358-2027
Halyard ARTHROSCOPY PACK. Model/Catalog Number: SAMM014-21.
AVID Medical, Inc.
- LRO
- Class II
- Open, Classified
Nov 4, 2026
Z-0357-2027
intelerad IntelePACS software
INTELERAD MEDICAL SYSTEMS INCORPORATED
- LLZ
- Class II
- Open, Classified
Nov 4, 2026
Z-0328-2027
Senographe Pristina 3D
GE Medical Systems, LLC
- OTE
- Class III
- Open, Classified
Nov 4, 2026
Z-0327-2027
Senographe Pristina
GE Medical Systems, LLC
- MUE
- Class II
- Open, Classified
Nov 4, 2026
Z-0326-2027
Senographe Pristina
GE Medical Systems, LLC
- MUE
- Class II
- Open, Classified
Nov 4, 2026
Z-0315-2027
Carevo, Height-adjustable shower trolley, Model Number BAC1111-01
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
- FSA
- Class II
- Ongoing
Nov 4, 2026
Z-0314-2027
Precision Pointer Electromagnetic (8000-050-001)
Stryker Leibinger GmbH & Co. KG
- HAW
- Class II
- Ongoing
Nov 4, 2026
Z-0311-2027
Nalu TD2 Therapy Disc with firmware, REF: 34014-001, and TD2 Patient Kit, REF: 74011, part of the Nalu Neurostimulation System
Boston Scientific Neuromodulation Corporation
- GZB
- Class II
- Ongoing
Nov 4, 2026
Z-0310-2027
PENTAX Medical Water bottle assembly. Model Number. OS-H5.
Pentax of America Inc
- PEA
- Class II
- Ongoing
Warning letters
See all 1 from this weekNov 3, 2026
Center for Devices and Radiological Health
CGMP/QSR/Medical Devices/Adulterated
Next Medical Products Company, LLC