Sep 15, 2026
K254299
CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS)
Karl Storz SE & CO. KG
- EOB
- Class II
510(k) clearances
Decision dates from openFDA device 510(k) records. Newest first.
746 records
Sep 15, 2026
K254214
OOOPDS
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
- LLZ
- Class II
Sep 14, 2026
K262193
RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface Technology
Xenix Medical
- NKB
- Class II
Sep 14, 2026
K262163
BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth
Becton Dickinson and Company
- JTZ
- Class II
Sep 14, 2026
K261517
qCT Lung (v1.0)
Qure.Ai Technologies Pvt. , Ltd.
- QDQ
- Class II
Sep 14, 2026
K261438
HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)
Eurosets S.R.L
- DTZ
- Class II
Sep 14, 2026
K261089
Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit
Maduro Medical, Inc.
- NRY
- Class II
Sep 14, 2026
K260795
Hand-held Dental X-ray System (HyperLight-M)
Changzhou Sifary Medical Technology Co., Ltd.
- EHD
- Class II
Sep 14, 2026
K260781
Yumizen H550
HORIBA ABX SAS
- GKZ
- Class II
Sep 14, 2026
K253481
colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72)
Ovesco Endoscopy AG
- PKL
- Class II
Sep 13, 2026
K262526
Safety lancet (XL)
Tianjin Huahong Technology Co., Ltd.
- FMK
- Class II
Sep 12, 2026
K261287
Digistat Care
Ascom Ums Srl Unipersonale
- MSX
- Class II
Sep 12, 2026
K260133
CADDIE
Odin Medical Limited
- QNP
- Class II
Sep 11, 2026
K262874
CraniUS Plate
CraniUS, LLC
- GWO
- Class II
Sep 11, 2026
K262861
PureLift Pro Max
Xtreem Pulse, LLC
- NFO
- Class II
Sep 11, 2026
K262763
iLet Dosing Decision Software
Beta Bionics, Inc.
- QJI
- Class II
Sep 11, 2026
K262397
CuratOR EX2742
Eizo Corporation
- GCJ
- Class II
Sep 11, 2026
K262230
Mg OSTEOREVIVE™;Mg OSTEOCRETE™
Bone Solutions, Inc.
- MQV
- Class II
Sep 11, 2026
K262151
SpaceOAR Flex™ System
Boston Scientific Corporation
- OVB
- Class II
Sep 11, 2026
K262050
Vioseal X
Spident Co., Ltd.
- KIF
- Class II
Sep 11, 2026
K262025
Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF System
INNO Holdings Inc. DBA Innovasis
- OVD
- Class II
Sep 11, 2026
K262007
PRIMED AAMI Level 3 Open Back Gowns
PRIMED Medical Products, Inc.
- QPC
- Class II
Sep 11, 2026
K261837
FINDER Flu A&B/SARS-CoV-2 Test
Baebies, Inc.
- QOF
- Class II
Sep 11, 2026
K261807
Sequential Circulator (SC-4004-DL, SC-4008-DL)
Bio Compression Systems, Inc.
- JOW
- Class II
Sep 11, 2026
K261580
ZBPro Diagnostic (Version 2.0)
Zbeats, Inc.
- MLO
- Class II