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
8593–8616 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 21, 2023
Absorbable Cranial Flap Fixation System
K221606 · GXR
Chendu Medart Medical Scientific Co.,...
Neurology · 537d
Cleared Nov 20, 2023
Single Use Non-Stick McPherson Bipolar Forceps, 110mm, 0.5mm Tip with Cable...
K233351 · GEI
Hg Innovations, Ltd.
General & Plastic Surgery · 52d
Cleared Nov 20, 2023
Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 0.5mm Tip with...
K233346 · GEI
Hg Innovations, Ltd.
General & Plastic Surgery · 52d
Cleared Nov 20, 2023
Hair Removal Device, Model(s): R2815-G Pro, R2815-G
K232575 · OHT
Shenzhen Jianchao Intelligent...
General & Plastic Surgery · 87d
Cleared Nov 20, 2023
Harmony
K232555 · NFJ
Topcon Healthcare Solutions
Ophthalmic · 89d
Cleared Nov 20, 2023
The SensiTox B. anthracis Toxin Test
K232545 · QUU
First Light Diagnostics, Inc.
Microbiology · 90d
Cleared Nov 20, 2023
ARIETTA x10
K231941 · IYN
Fujifilm Healthcare Americas Corporation
Radiology · 143d
Cleared Nov 20, 2023
Ziehm Vision RFD
K231692 · OWB
Ziehm Imaging GmbH
Radiology · 164d
Cleared Nov 20, 2023
TraumaCad Neo
K231498 · LLZ
Brainlab , Ltd.
Radiology · 180d
Cleared Nov 20, 2023
RIWOtrack Navigation System
K230700 · OLO
Fiagon GmbH
Orthopedic · 252d
Cleared Nov 20, 2023
Zilia Ocular FC (ZIL-10002)
K230627 · HKI
Zilia, Inc.
Ophthalmic · 259d
Cleared Nov 17, 2023
EKGenius Smart System
K232974 · DPS
Ekgenius, LLC
Cardiovascular · 57d
Cleared Nov 17, 2023
Gastric Alimetry System
K232925 · MYE
Alimetry , Ltd.
Gastroenterology & Urology · 59d
Cleared Nov 17, 2023
DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR...
K232538 · LZA
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 87d
Cleared Nov 17, 2023
Masimo W1
K232512 · DPS
Masimo Corporation
Cardiovascular · 91d
Cleared Nov 17, 2023
AI Platform (AIP001)
K232501 · QIH
Exo, Inc.
Radiology · 92d
Cleared Nov 17, 2023
Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100)
K232028 · FDS
Iq Endoscopes Limited
Gastroenterology & Urology · 133d
Cleared Nov 17, 2023
SENDERO Microcatheter
K231600 · DQY
Okami Medical, Inc.
Cardiovascular · 169d
Cleared Nov 17, 2023
Multi-Unit DAS System
K231559 · NHA
Talladium Espa?a, SL
Dental · 171d
Cleared Nov 17, 2023
Alinity c Tricyclic Antidepressants Reagent Kit
K231020 · LFH
Microgenics Corporation
Toxicology · 221d
Cleared Nov 17, 2023
Samfilcon B Custom Contact Lens
K230954 · LPL
Bausch & Lomb, Incorporated
Ophthalmic · 227d
Cleared Nov 17, 2023
Edwards Algorithm for Measurement of Blood Hemoglobin
K230612 · MUD
Edwards Lifesciences, LLC
Cardiovascular · 256d
Cleared Nov 17, 2023
Celox Rapid X-Ray Gauze
K230589 · QSY
Medtrade Products , Ltd.
General & Plastic Surgery · 260d
Cleared Nov 17, 2023
Polyver Silver Alginate Dressing (Prescription and OTC)
K230190 · FRO
Roosin Medical Co., Ltd.
General & Plastic Surgery · 297d