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
8425–8448 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 06, 2023
Mouth Guard (ATG0603R)
K231865 · OBR
Reazeal Corp
Dental · 133d
Cleared Nov 06, 2023
Revital Cady
K231519 · FMF
Revital Healthcare (Epz) Limited
General Hospital · 165d
Cleared Nov 06, 2023
Lunit INSIGHT DBT
K231470 · QDQ
Lunit, Inc.
Radiology · 168d
Cleared Nov 06, 2023
Aptima Trichomonas vaginalis Assay
K231316 · OUY
Hologic, Inc.
Microbiology · 182d
Cleared Nov 03, 2023
Easycess Aspiration Pump
K233428 · JCX
Guangzhou Easycess Medical Co.,Ltd
General & Plastic Surgery · 23d
Cleared Nov 03, 2023
Arthrex FiberTak Suture Anchor
K232742 · MBI
Arthrex, Inc.
Orthopedic · 57d
Cleared Nov 03, 2023
Control-IQ Technology
K232382 · QJI
Tandem Diabetes Care, Inc.
Chemistry · 87d
Cleared Nov 03, 2023
t:slim X2 Insulin Pump with Interoperable Technology
K232380 · QFG
Tandem Diabetes Care, Inc.
Chemistry · 87d
Cleared Nov 03, 2023
Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile,...
K232266 · LZA
Better Care Plastic Technology Co., Ltd.
General Hospital · 95d
Cleared Nov 03, 2023
APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line...
K232251 · HWC
Medartis AG
Orthopedic · 98d
Cleared Nov 03, 2023
LOGIQ e
K232186 · IYN
Ge Medical Systems Ultrasound and...
Radiology · 102d
Cleared Nov 03, 2023
Halcyon, Ethos Radiotherapy System
K232113 · IYE
Varian Medical Systems, Inc.
Radiology · 112d
Cleared Nov 03, 2023
aprevo® Digital Segmentation
K231955 · QIH
Carlsmed, Inc.
Radiology · 123d
Cleared Nov 03, 2023
Freedom60 Infusion Pump
K231918 · FRN
Koru Medical Systems
General Hospital · 127d
Cleared Nov 03, 2023
Endophys Blood Pressure Monitor model BPM-30
K231586 · DSK
Endophys Technologies, LLC
Cardiovascular · 156d
Cleared Nov 03, 2023
ManaFlexx 2 (model: MF002-RX, MF002-OTC)
K231569 · NUH
Manamed, Inc.
Neurology · 156d
Cleared Nov 03, 2023
Combo Electrotherapy Device
K231440 · IPF
Shenzhen Roundwhale Technology Co. ,...
Physical Medicine · 169d
Cleared Nov 03, 2023
GripTract-GI Endoscopic Tissue Manipulator
K231254 · FDF
Actuated Medical, Inc.
Gastroenterology & Urology · 186d
Cleared Nov 03, 2023
Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature...
K231182 · NZE
Zoll Circulation, Inc.
Cardiovascular · 191d
Cleared Nov 03, 2023
Evenflo Premium Double Electric Breast Pump (Model 4018)
K230481 · HGX
Evenflo Feeding, Inc.
Obstetrics & Gynecology · 254d
Cleared Nov 03, 2023
Medical Video Endoscope System
K230475 · FGB
Huger Medical Instrument Co., Ltd.
Gastroenterology & Urology · 254d
Cleared Nov 03, 2023
ProSeal™ Closed System Administration Set
K230343 · FPA
Epic Medical Pte. , Ltd.
General Hospital · 268d
Cleared Nov 03, 2023
SCIZER (SC1-M410)
K230100 · OHV
Classys, Inc.
General & Plastic Surgery · 294d
Cleared Nov 03, 2023
TRAX® CR Total Knee System
K230078 · JWH
Amplitude
Orthopedic · 297d