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
10921–10944 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 10, 2023
Glass Ceramic
K223194 · EIH
Shenzhen Xiangtong Co., Ltd.
Dental · 120d
Cleared Feb 10, 2023
Safety Lancet
K223208 · FMK
Suzhou Zhenwu Medical Co., Ltd.
General & Plastic Surgery · 116d
Cleared Feb 10, 2023
Pro-Tx Endorectal Balloon (PROT-25)
K223249 · PCT
Dxtx Medical, Inc.
Radiology · 151d
Cleared Feb 10, 2023
Pisces™-SA STANDALONE ALIF Interbody System
K223413 · OVD
Osseus Fusion Systems
Orthopedic · 93d
Cleared Feb 10, 2023
MD.ai Viewer
K223425 · LLZ
Mdai, Inc.
Radiology · 88d
Cleared Feb 10, 2023
TELIGEN System Peripheral Motor Nerve Stimulation Indications
K223438 · PDQ
Medos International SARL
Neurology · 88d
Cleared Feb 10, 2023
Disposable Isolation Gown
K223467 · FYC
Nanning Tecbod Biological Technology...
General Hospital · 85d
Cleared Feb 10, 2023
Eneka Pro
K223680 · GEX
Termosalud
General & Plastic Surgery · 64d
Cleared Feb 10, 2023
Orthex External Fixation System
K223786 · KTT
OrthoPediatrics Corp.
Orthopedic · 53d
Cleared Feb 09, 2023
Insulin syringe with integrated needle DL
K203211 · FMF
Dlp Medical Products, Corp.
General Hospital · 832d
Cleared Feb 09, 2023
ATTIVA
K220505 · GEI
Italian Engineering S.R.L.
General & Plastic Surgery · 352d
Cleared Feb 09, 2023
extriCARE® 3000 Negative Wound Pressure Therapy System
K221223 · OMP
Alleva Medical Devices
General & Plastic Surgery · 287d
Cleared Feb 09, 2023
hygh-tec drainage
K221400 · KNT
Creative Balloons GmbH
Gastroenterology & Urology · 269d
Cleared Feb 09, 2023
External Drainage System
K221694 · JXG
Jmed(Shenzhen) Technology Limited
Neurology · 244d
Cleared Feb 09, 2023
CYGNUS-C Standalone ACIF System
K222041 · OVE
GS Medical Co., Ltd.
Orthopedic · 213d
Cleared Feb 09, 2023
VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL)
K222073 · LON
bioMerieux, Inc.
Microbiology · 210d
Cleared Feb 09, 2023
Toothsi, Smilealigners
K223338 · NXC
Makeo Healthcare Technologies Private...
Dental · 100d
Cleared Feb 09, 2023
Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With...
K223559 · LZA
Nephron Pharmaceuticals Corporation
General Hospital · 73d
Cleared Feb 09, 2023
Sterile Syringes for Single Use
K223678 · FMF
Shanghai Kindly Enterprise...
General Hospital · 63d
Cleared Feb 09, 2023
G Surgical Marksman Spinal Deformity System
K230063 · NKB
G Surgical, LLC
Orthopedic · 31d
Cleared Feb 09, 2023
Okti
K230073 · GWQ
Compumedics Limited
Neurology · 30d
Cleared Feb 09, 2023
ETHICON LINX® Esophagus Sizing Tool
K230089 · QJN
Torax Medical, Inc.
Gastroenterology & Urology · 28d
Cleared Feb 08, 2023
Filter and HME/Filter
K221472 · CAH
Ningbo Huakun Medical Equipment Co.,...
General Hospital · 264d
Cleared Feb 08, 2023
Hailie Sensor NF0110
K222247 · CAF
Adherium (Nz), Ltd.
Anesthesiology · 197d