FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
433–456 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 20, 2026
Kneu Platform (V2)
K262515 · GYD
Kneu Health Digital , Ltd.
Neurology · 30d
Cleared Aug 20, 2026
Remex Spine Surgery Navigation - Universal Instruments
K262506 · OLO
Remex Medical Corp.
Orthopedic · 30d
Cleared Aug 20, 2026
HardyDisk AST Tebipenem 10µg (TBP10)
K262113 · JTN
Hardy Diagnostics
Microbiology · 58d
Cleared Aug 20, 2026
Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))
K261298 · HGX
Guangdong Youmeng Electrical...
Obstetrics & Gynecology · 122d
Cleared Aug 20, 2026
SCALA® TL
K261049 · MAX
Spineart SA
Orthopedic · 142d
Cleared Aug 20, 2026
MIRA Surgical System
K260817 · SAB
Virtual Incision
General & Plastic Surgery · 160d
Cleared Aug 20, 2026
Infinity® Acute Care System (IACS) – VG8.1
K260579 · MHX
Draeger Medical Systems, Inc.
Cardiovascular · 181d
Cleared Aug 20, 2026
CPETWise Platform
K260242 · BTY
Medibyt , Ltd.
Anesthesiology · 206d
Cleared Aug 20, 2026
Valence InVent Xtend™ (CVG-4101-VXA)
K253807 · MOD
Convergence Medical Sciences , Ltd.
Anesthesiology · 265d
Cleared Aug 19, 2026
Swoop® Portable MR Imaging® System
K262622 · LNH
Hyperfine, Inc.
Radiology · 22d
Cleared Aug 19, 2026
Versalock Sterile Plating System
K262537 · HRS
GM Dos Reis Industria e Comercio Ltda.
Orthopedic · 27d
Cleared Aug 19, 2026
Diode Laser Therapy Systems (DL612A)
K262070 · GEX
Hebei Zollvan Medical Technology Co.,...
General & Plastic Surgery · 58d
Cleared Aug 19, 2026
ECHOLASER X4
K261964 · GEX
Elesta S.P.A
General & Plastic Surgery · 69d
Cleared Aug 19, 2026
Elecsys Phospho-Tau (217P) Plasma
K261686 · SET
Roche Diagnostics
Immunology · 90d
Cleared Aug 19, 2026
EXTRON 3
K261413 · OWB
DRTECH Corporation
Radiology · 111d
Cleared Aug 19, 2026
Wallace® Aspiration Pump (WAPV1)
K261083 · MQG
CooperSurgical, Inc.
Obstetrics & Gynecology · 140d
Cleared Aug 19, 2026
Nipro Dry Acid Concentrate Mixer
K260799 · KPO
Nipro Technical Solutions, Incoporated
Gastroenterology & Urology · 161d
Cleared Aug 19, 2026
ZEROS Dental Implant System
K260463 · DZE
Zeros Co., Ltd.
Dental · 188d
Cleared Aug 19, 2026
ENDOFLATOR+
K260209 · HIF
Karl Storz SE & CO. KG
Obstetrics & Gynecology · 208d
Cleared Aug 19, 2026
Pascall Sensor Unit (PSU1)
K254213 · OLT
Pascall Systems, Inc.
Neurology · 233d
Cleared Aug 19, 2026
Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ...
K253431 · LXB
Shokz Health Global Limited
Ear, Nose, Throat · 322d
Cleared Aug 19, 2026
PrecivityAD2 Test
K253240 · SET
C2N Diagnostics, LLC
Immunology · 324d
Cleared Aug 18, 2026
TeKBrace Solo Soft Tissue Reinforcement Device
K262729 · QUW
Theramicro
Orthopedic · 18d
Cleared Aug 18, 2026
BluEX Cervical Expandable Cage System
K262489 · ODP
L & K Biomed Co., Ltd.
Orthopedic · 29d