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
10345–10368 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 13, 2023
CerebralGo Plus
K213986 · QIH
Yukun (Beijing) Technology Co., Ltd.
Radiology · 479d
Cleared Apr 13, 2023
ALPCO Calprotectin Immunoturbidimetric Assay
K220763 · NXO
ALPCO
Immunology · 393d
Cleared Apr 13, 2023
Stratus Infusion Catheter
K222185 · NPG
Intervene, Inc.
Cardiovascular · 265d
Cleared Apr 13, 2023
CIRRUS HD-OCT
K222200 · OBO
Carl Zeiss Meditec, Inc.
Ophthalmic · 262d
Cleared Apr 13, 2023
Sterile Nitrile Surgical Gloves Powder Free
K222350 · KGO
Jr Engineering & Medical Technologies...
General Hospital · 253d
Cleared Apr 13, 2023
Point implant system
K222738 · DZE
Pointnix Co., Ltd.
Dental · 216d
Cleared Apr 13, 2023
FreeStyle Libre 3 Continuous Glucose Monitoring System
K223435 · QBJ
Abbott Diabetes Care, Inc.
Chemistry · 150d
Cleared Apr 13, 2023
Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)
K223879 · DTR
Quara S.R.L.
Cardiovascular · 107d
Cleared Apr 13, 2023
ADSEAL Plus
K230010 · KIF
Meta Biomed Co., Ltd.
Dental · 100d
Cleared Apr 13, 2023
Trusana™
K230098 · EBI
Myerson, LLC
Dental · 90d
Cleared Apr 13, 2023
DESS Dental Smart Solutions
K230143 · NHA
Terrats Medical SL
Dental · 85d
Cleared Apr 13, 2023
Ezra Flash
K230264 · LLZ
Ezra Ai, Inc.
Radiology · 72d
Cleared Apr 13, 2023
ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C)
K230387 · GEI
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 58d
Cleared Apr 13, 2023
UniCam Evo Software
K230393 · LLZ
Inter Medical Medizintechnik GmbH
Radiology · 58d
Cleared Apr 13, 2023
Symmed Elite Aesthetic
K230412 · PBX
Termosalud
General & Plastic Surgery · 57d
Cleared Apr 13, 2023
NaviCam Xpress Stomach System, NaviCam Xpress System
K230694 · QKZ
Anx Robotica Corp
Gastroenterology & Urology · 31d
Cleared Apr 13, 2023
BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini
K230719 · QOF
Biofire Diagnostics, LLC
Microbiology · 29d
Cleared Apr 13, 2023
SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE®...
K230868 · PMN
Maine Molecular Quality Controls, Inc.
Microbiology · 15d
Cleared Apr 12, 2023
Polyfusion IV Administration Sets
K220312 · FPA
Poly Medicure Limited
General Hospital · 434d
Cleared Apr 12, 2023
Task Force CORE
K223332 · DXN
Cnsystems Medizintechnik GmbH
Cardiovascular · 163d
Cleared Apr 12, 2023
Catalys™ Precision Laser System
K223838 · OOE
Amo Manufacturing USA, LLC
Ophthalmic · 111d
Cleared Apr 12, 2023
Omnia Medical Coupler-A™ Anterior Lumbar Plate System
K230424 · KWQ
Omnia Medical, LLC
Orthopedic · 54d
Cleared Apr 11, 2023
Neuspera Nuity System
K221303 · GZF
Neuspera Medical, Inc.
Neurology · 341d
Cleared Apr 11, 2023
Augmento
K222781 · LLZ
Deeptek Medical Imaging Private Limited
Radiology · 208d