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
12841–12864 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 05, 2022
Non-Sterile Powder Free Nitrile Examination Gloves (Tested for Use with...
K221350 · LZA
Rubberex Alliance Products Sdn Bhd
General Hospital · 87d
Cleared Aug 05, 2022
Neurophet SCALE PET
K221405 · LLZ
Neurophet., Inc.
Radiology · 81d
Cleared Aug 04, 2022
CenterMed Patient Matched Assisted Surgical Planning (ASP) System
K211614 · PBF
Centermed, Inc.
Orthopedic · 435d
Cleared Aug 04, 2022
Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light...
K220001 · DFH
Diazyme Laboratories, Inc.
Immunology · 212d
Cleared Aug 04, 2022
MDHearingAid app, MDHearingAid Smart hearing aids
K220303 · QDD
Mdhearingaid
Ear, Nose, Throat · 183d
Cleared Aug 04, 2022
Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series)
K220524 · NUH
Well-Life Healthcare Limited
Neurology · 162d
Cleared Aug 04, 2022
Mini-ClotTriever Thrombectomy System
K220887 · QEW
Inari Medical
Cardiovascular · 129d
Cleared Aug 04, 2022
Actera™ hip system
K221104 · MEH
Conformis, Inc.
Orthopedic · 112d
Cleared Aug 04, 2022
MANTIS Clip
K221124 · PKL
Boston Scientific Corporation
Gastroenterology & Urology · 108d
Cleared Aug 04, 2022
Bloomi Smooth Water Based Lubricant
K221328 · NUC
The Bloomi Inc..
Obstetrics & Gynecology · 90d
Cleared Aug 04, 2022
exGraft, exGraft Carbon
K221628 · DSY
Peca Labs
Cardiovascular · 59d
Cleared Aug 04, 2022
Endoscope Model EG-580UT and Endoscope Model EG-580UR
K221952 · ODG
Fujifilm Corporation
Gastroenterology & Urology · 30d
Cleared Aug 04, 2022
Masimo CARESCAPE SpO2 – Masimo with SpHb
K221953 · DQA
Masimo Corporation
Anesthesiology · 30d
Cleared Aug 03, 2022
Solidence Multipockets
K191131 · FRG
Solidence Surgical Corporation
General Hospital · 1192d
Cleared Aug 03, 2022
ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP...
K212181 · DHB
Phadia AB
Immunology · 386d
Cleared Aug 03, 2022
Root ZX3
K213477 · EKZ
J. Morita USA, Inc.
Dental · 278d
Cleared Aug 03, 2022
Cannulated Screws
K213614 · HWC
Maxxion Medical, LLC
Orthopedic · 261d
Cleared Aug 03, 2022
QScreen
K220139 · GWJ
Path Medical GmbH
Ear, Nose, Throat · 197d
Cleared Aug 03, 2022
Transpara 1.7.2
K221347 · QDQ
Screenpoint Medical B.V.
Radiology · 86d
Cleared Aug 03, 2022
Customize
K221432 · QIH
3D-Side S.A.
Radiology · 78d
Cleared Aug 02, 2022
QOCA Portable ECG Monitoring Device
K210179 · DSH
Quanta Computer, Inc.
Cardiovascular · 557d
Cleared Aug 02, 2022
iStent infinite Trabecular Micro-Bypass System, Model iS3
K220032 · KYF
Glaukos Corporation
Ophthalmic · 209d
Cleared Aug 02, 2022
BruxZir NOW
K220816 · EIH
Prismatik Dentalcraft, Inc.
Dental · 134d
Cleared Aug 01, 2022
Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with...
K213929 · LZA
O&M Halyard, Inc.
General Hospital · 228d