FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
12769–12792 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 16, 2022
ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select...
K221190 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 113d
Cleared Aug 16, 2022
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6...
K221852 · PPN
Shockwave Medical, Inc.
Cardiovascular · 50d
Cleared Aug 16, 2022
FairFix Adjustable Button System
K222169 · MBI
Medacta International S.A.
Orthopedic · 26d
Cleared Aug 15, 2022
XLase Plus
K212790 · GEX
Biotec Italia, Srl
General & Plastic Surgery · 348d
Cleared Aug 15, 2022
FORUM
K213527 · NFJ
Carl Zeiss Meditec, AG
Ophthalmic · 284d
Cleared Aug 15, 2022
HeRO Graft
K213845 · DSY
Merit Medical Systems, Inc.
Cardiovascular · 249d
Cleared Aug 15, 2022
da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments
K214095 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 230d
Cleared Aug 15, 2022
Her-2, ER, PR IHControls
K220163 · NJW
Boston Cell Standards, Inc.
Pathology · 207d
Cleared Aug 15, 2022
Recon Steerable Sheath
K221302 · EOQ
Serpex Medical, Inc.
Ear, Nose, Throat · 102d
Cleared Aug 12, 2022
ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion...
K202461 · LGZ
Smisson-Cartledge Biomedical, LLC
General Hospital · 715d
Cleared Aug 12, 2022
Hemo-Lyte C Cartridge
K202508 · KPO
Di-Chem, Inc.
Gastroenterology & Urology · 711d
Cleared Aug 12, 2022
Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood...
K202739 · NBW
Bioland Technology, Ltd.
Chemistry · 693d
Cleared Aug 12, 2022
SKOUT Software
K213686 · QNP
Iterative Scopes, Inc.
Gastroenterology & Urology · 263d
Cleared Aug 12, 2022
Visibly Digital Acuity Product
K220090 · QTO
Visibly, Inc.
Ophthalmic · 213d
Cleared Aug 12, 2022
TeraRecon Neuro
K220349 · LLZ
Terarecon,Inc.
Radiology · 186d
Cleared Aug 12, 2022
Intense Pulsed Light Equipment
K220385 · ONF
Beijing Globalipl Development Co., Ltd.
General & Plastic Surgery · 183d
Cleared Aug 12, 2022
Vibe SF Self-Fitting Hearing Aid
K220403 · QDD
Wsaud A/S
Ear, Nose, Throat · 182d
Cleared Aug 12, 2022
Blue Eye (TS-905)
K220434 · PLL
The Standard Co., Ltd.
Gastroenterology & Urology · 178d
Cleared Aug 12, 2022
Denture Base Polymers
K220680 · EBI
Shandong Huge Dental Material...
Dental · 157d
Cleared Aug 12, 2022
Arkligners
K220835 · NXC
Arklign Laboratories
Dental · 143d
Cleared Aug 12, 2022
Isolation Gown (S, M, L, XL, XXL (Yellow, Blue))
K221027 · FYC
Allmed Medical (Hubei) Protective...
General Hospital · 128d
Cleared Aug 12, 2022
Zavation VariSync Plate System and VariSync Spacer System
K221049 · OVE
Zavation Medical Products, LLC
Orthopedic · 123d
Cleared Aug 12, 2022
Unistik® 3, sterile single-use safety lancets
K221126 · FMK
Owen Mumford, Ltd.
General & Plastic Surgery · 116d
Cleared Aug 12, 2022
Tasso+
K221131 · FMK
Tasso, Inc.
General & Plastic Surgery · 116d