Aug 19, 2026
K260799
Nipro Dry Acid Concentrate Mixer
Nipro Technical Solutions, Incoporated
- KPO
- Class II
510(k) clearances
Decision dates from openFDA device 510(k) records. Newest first.
746 records
Aug 19, 2026
K260463
ZEROS Dental Implant System
Zeros Co., Ltd.
- DZE
- Class II
Aug 19, 2026
K260209
ENDOFLATOR+; Smart Smoke Evacuation
Karl Storz SE & CO. KG
- HIF
- Class II
Aug 19, 2026
K254213
Pascall Sensor Unit (PSU1)
Pascall Systems, Inc.
- OLT
- Class II
Aug 19, 2026
K253431
Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN)
Shokz Health Global Limited
- LXB
- Class II
Aug 19, 2026
K253240
PrecivityAD2 Test
C2N Diagnostics, LLC
- SET
- Class II
Aug 19, 2026
DEN250046
Aletta® Autonomous Robotic Phlebotomy Device (ARPD™) (Gen1 US)
Vitestro
- SIW
- Class II
Aug 18, 2026
K262729
TeKBrace Solo Soft Tissue Reinforcement Device
Theramicro
- QUW
- Class II
Aug 18, 2026
K262489
BluEX Cervical Expandable Cage System
L&K BIOMED Co., Ltd.
- ODP
- Class II
Aug 18, 2026
K262479
TearCare System
Sight Sciences, Inc.
- ORZ
- Class II
Aug 18, 2026
K262135
Lancing device
Tianjin Huahong Technology Co., Ltd.
- QRL
- Class II
Aug 18, 2026
K261641
Lower Limb AI (LLAI)
AI Planning Logic, Inc.
- QIH
- Class II
Aug 18, 2026
K260984
HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)
Axora Medical, Inc.
- HIH
- Class II
Aug 18, 2026
K260794
NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLOR
Kossan International Sdn Bhd
- LZA
- Class I
Aug 18, 2026
K260266
Tympendi™ (810)
Grace Medical, Inc.
- KHJ
- Class II
Aug 18, 2026
K254256
LUOFUCON® Wound Matrix
Huizhou Foryou Medical Devices Co., Ltd.
- QSZ
- Unclassified
Aug 18, 2026
K254071
p17 XR Microcatheter
Wallaby Medical
- QJP
- Class II
Aug 17, 2026
K261500
KBA3D (v2.4.0)
S.M.A.I.O
- LLZ
- Class II
Aug 17, 2026
K260224
MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)
ImpediMed Limited
- DSB
- Class II
Aug 17, 2026
K260137
KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient Solutions
KLS-Martin L.P.
- JEY
- Class II
Aug 17, 2026
K254250
MagicScan-1.5, GreenMR Serenity 1.5T
Xingaoyi Medical Equipment Co.,Ltd
- LNH
- Class II