FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: 2026–2026 ×
1,642 results
241–264 of 1,642
Search insights Median review: 137d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Jun 05, 2026
OsteoCool™ RF Ablation System
K253656 · GEI
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 197d
Cleared Jun 05, 2026
Digital C-ARM with 3D
K253296 · OXO
Allengers Medical Systems Limited
Radiology · 249d
Cleared Jun 05, 2026
Catalyze
K253204 · KGN
BioTissue Holdings, Inc.
General & Plastic Surgery · 252d
Cleared Jun 05, 2026
Temperature probes (T2252-PG)
K253162 · FLL
Unimed Medical Supplies, Inc.
General Hospital · 252d
Cleared Jun 05, 2026
VEOFIX Snap Off Screw
K253108 · HWC
Steps Ortho
Orthopedic · 254d
Cleared Jun 05, 2026
Alma TED+ System
K251684 · OAP
Alma Lasers, Inc.
General & Plastic Surgery · 368d
Cleared Jun 05, 2026
iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma...
K243192 · LPH
Nextstep Arthopedix, LLC
Orthopedic · 613d
Cleared Jun 04, 2026
Sonio Suspect
K261519 · POK
Sonio
Radiology · 28d
Cleared Jun 04, 2026
Signature™ ONE System
K261510 · QHE
Orthosoft Inc. (d/b/a) Zimmer CAS
Orthopedic · 28d
Cleared Jun 04, 2026
Spectra Platinum Mini
K260956 · HGX
Uzinmedicare Co., Ltd.
Obstetrics & Gynecology · 73d
Cleared Jun 04, 2026
LIAISON Murex HBsAg Qual
K260770 · LOM
DiaSorin, Inc.
Microbiology · 87d
Cleared Jun 04, 2026
LumiGlam Laser System (SHE-LSP601-3)
K260690 · GEX
Beijing Sano Laser S&T Development...
General & Plastic Surgery · 93d
Cleared Jun 04, 2026
Dental Cone Beam Computed Tomography System
K260662 · OAS
Yofo Medical Technology Co., Ltd.
Radiology · 94d
Cleared Jun 04, 2026
DEEPVESSEL Plaque
K260497 · QIH
Keya Medical Technology Co., Ltd.
Radiology · 111d
Cleared Jun 04, 2026
Radius VSM and Accessories
K254209 · MHX
Masimo Corporation
Cardiovascular · 157d
Cleared Jun 04, 2026
TroKit Laparoscope Lens Wiper
K253994 · GCJ
TroCare, LLC
General & Plastic Surgery · 174d
Cleared Jun 04, 2026
Instrument Exit Point on Touch Surgery™ Aide
K253984 · SFE
Covidien, LLC
General & Plastic Surgery · 174d
Cleared Jun 04, 2026
Harmony Referral System with Harmony OCT Viewer (Octave)
K253893 · NFJ
Topcon Healthcare Solutions EMEA Oy
Ophthalmic · 182d
Cleared Jun 04, 2026
Precision S 4K Sinuscope
K253602 · GWG
Stryker Endoscopy
Neurology · 198d
Cleared Jun 04, 2026
Orion
K253553 · BZD
ResMed Corp
Anesthesiology · 202d
Cleared Jun 04, 2026
GT Metabolic MagDI System (MAG-01, MAG-02, DS-01)
K253102 · SAH
Gt Metabolic Solutions, Inc.
General & Plastic Surgery · 253d
Cleared Jun 04, 2026
Respiratory Gating for Scanners (2.1)
K253026 · JAK
Varian Medical Systems, Inc.
Radiology · 258d
Cleared Jun 04, 2026
Strauss Surgical Resection Instruments
K253020 · HIH
American Medical Endoscopy, Inc.
Obstetrics & Gynecology · 258d
Cleared Jun 04, 2026
LUNA 3D
K253004 · IYE
Lap GmbH Laser Applikationen
Radiology · 258d