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: Cleared only ×
174,955 results
12505–12528 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 12, 2022
IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI17
K221466 · OHT
Shenzhen Century Dongyuan Technology...
General & Plastic Surgery · 85d
Cleared Aug 12, 2022
aprevo® anterior and lateral lumbar interbody fusion devices, aprevo®...
K222082 · MAX
Carlsmed, Inc.
Orthopedic · 28d
Cleared Aug 12, 2022
EzDent-i / E2 / Prora View/ Smart M Viewer
K222145 · LLZ
Ewoosoft Co., Ltd.
Radiology · 23d
Cleared Aug 11, 2022
Foundation Dermal Regeneration Scaffold (DRS) Solo
K210949 · KGN
Bionova Medical, Inc.
General & Plastic Surgery · 499d
Cleared Aug 11, 2022
Novo
K212361 · QKQ
PathAI, Inc.
Pathology · 377d
Cleared Aug 11, 2022
AI-Rad Companion (Pulmonary)
K213713 · JAK
Siemens Healthcare GmbH
Radiology · 260d
Cleared Aug 11, 2022
KLS Martin IPS Distraction
K220050 · MQN
KLS-Martin L.P.
Dental · 217d
Cleared Aug 11, 2022
Patient Monitor: RespArray
K220308 · MHX
Edan Instruments, Inc.
Cardiovascular · 190d
Cleared Aug 11, 2022
NEUWAVE Microwave Ablation System and Accessories
K220472 · NEY
Neuwave Medical, Inc.
General & Plastic Surgery · 174d
Cleared Aug 11, 2022
OMF ASP System
K220648 · DZJ
Vha Dean
Dental · 157d
Cleared Aug 11, 2022
Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem
K220731 · MEH
Stryker
Orthopedic · 150d