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
8377–8400 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 14, 2023
BrainSpec Core™ Software
K230856 · LLZ
Brainspec, Inc.
Radiology · 230d
Cleared Nov 13, 2023
Accu-Chek Safe-T-Pro Uno Lancing Device
K232509 · FMK
Roche Diabetes Care, Inc.
General & Plastic Surgery · 87d
Cleared Nov 13, 2023
Accu-Chek Safe-T-Pro Plus Lancing Device
K232488 · FMK
Roche Diabetes Care, Inc.
General & Plastic Surgery · 88d
Cleared Nov 13, 2023
Clarius Bladder AI
K232257 · QIH
Clarius Mobile Health Corp.
Radiology · 108d
Cleared Nov 13, 2023
Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815,...
K232241 · NEY
Betters(Suzhou) Medical Co., Ltd.
General & Plastic Surgery · 108d
Cleared Nov 13, 2023
Microwave Ablation System (BD-GT)
K232240 · NEY
Betters(Suzhou) Medical Co., Ltd.
General & Plastic Surgery · 108d
Cleared Nov 13, 2023
BriefCase-Quantification
K232083 · QIH
Aidoc Medical , Ltd.
Radiology · 123d
Cleared Nov 13, 2023
Foundation Dermal Regeneration Scaffold (DRS) Solo
K231937 · KGN
Bionova Medical, Inc.
General & Plastic Surgery · 136d
Cleared Nov 13, 2023
Cystoscope System
K231118 · FAJ
Shenzhen HugeMed Medical Technical...
Gastroenterology & Urology · 207d
Cleared Nov 13, 2023
ELLAVI UBT
K230849 · OQY
Sinapi Biomedical (Pty) , Ltd.
Obstetrics & Gynecology · 230d
Cleared Nov 13, 2023
INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid
K230831 · MBF
Depuy Ireland UC
Orthopedic · 231d
Cleared Nov 10, 2023
Skin and Wound Cleanser
K231564 · FRO
Winner Medical Co., Ltd.
General & Plastic Surgery · 163d
Cleared Nov 09, 2023
VarseoSmile TriniQ
K233596 · EBF
Bego Bremer Goldschl?gerei Wilh....
Dental · 1d
Cleared Nov 09, 2023
Materialise Shoulder System™, Materialise Shoulder Guide and Models,...
K233408 · QHE
Materialise NV
Orthopedic · 34d
Cleared Nov 09, 2023
SYMPHONY OCT System
K233366 · NKG
Medos International SARL
Orthopedic · 38d
Cleared Nov 09, 2023
Dental Handpiece, Wireless Endodontic Handpiece, endoit
K232810 · EKX
Micro-Nx Co., Ltd.
Dental · 58d
Cleared Nov 09, 2023
Disposable Endoscope Injection Needles
K232442 · FBK
Zhejiang Soudon Medical Technology...
Gastroenterology & Urology · 87d
Cleared Nov 09, 2023
Longeviti ClearFit OTS Cranial Implant
K231920 · GXN
Longeviti Neuro Solutions, LLC
Neurology · 133d
Cleared Nov 09, 2023
Glenoid Reconstruction System – Full Wedge Baseplate
K231911 · PHX
Medacta International S.A.
Orthopedic · 133d
Cleared Nov 09, 2023
PRIME-XV FreezIS DMSO-Free MD
K231804 · NDS
Fujifilm Irvine Scientific
Gastroenterology & Urology · 142d
Cleared Nov 09, 2023
ARK Hydrocodone Assay
K231752 · DJG
ARK Diagnostics, Inc.
Chemistry · 147d
Cleared Nov 09, 2023
Flush Syringe (Prefilled 0.9% normal saline solution)
K231724 · NGT
Spm Medicare Pvt. , Ltd.
General Hospital · 149d
Cleared Nov 09, 2023
MAGNETOM Free.Max
K231617 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 160d
Cleared Nov 09, 2023
Power Wheelchair, W5521
K231508 · ITI
Zhejiang Innuovo Rehabilitation...
Physical Medicine · 168d