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
8689–8712 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 08, 2023
BriefCase-Quantification
K230534 · QIH
Aidoc Medical , Ltd.
Radiology · 254d
Cleared Nov 08, 2023
Cure Catheter Closed System
K230400 · EZD
Convatec, Inc.
Gastroenterology & Urology · 266d
Cleared Nov 08, 2023
VS Tabletop Tonometer
K223739 · HKX
Medimaging Integrated Solution, Inc.
Ophthalmic · 329d
Cleared Nov 07, 2023
Axium Detachable Coil
K233420 · HCG
Micro Therapeutics Lnc. D/B/A Ev3...
Neurology · 28d
Cleared Nov 07, 2023
Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical...
K232866 · GCJ
Jiangsu Channel Medical Device Co., Ltd.
General & Plastic Surgery · 53d
Cleared Nov 07, 2023
Disposable Sphincterotome
K232476 · KNS
Zhejiang Soudon Medical Technology...
Gastroenterology & Urology · 83d
Cleared Nov 07, 2023
Peridot-EX Expandable Intervertebral Body Fusion System
K232292 · MAX
Gbs Commonwealth Co., Ltd.
Orthopedic · 98d
Cleared Nov 07, 2023
LOGIQ E10s, LOGIQ Fortis
K231989 · IYN
Ge Medical Systems Ultrasound and...
Radiology · 125d
Cleared Nov 07, 2023
LOGIQ E10
K231966 · IYN
GE Medical Systems Ultrasound and...
Radiology · 127d
Cleared Nov 07, 2023
Biodegradable Medical surgical mask
K231155 · FXX
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital · 197d
Cleared Nov 06, 2023
KARL STORZ ICG Imaging System
K232857 · OWN
Karl Storz SE & CO. KG
General & Plastic Surgery · 52d
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