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
12529–12552 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 11, 2022
Medical image processing software
K220910 · JAK
Hangzhou Deepwise & League of PHD...
Radiology · 135d
Cleared Aug 11, 2022
Erbe's Tubing/Cap Sets
K221177 · OCX
Erbe USA, Inc.
Gastroenterology & Urology · 108d
Cleared Aug 11, 2022
LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02)
K221385 · PLL
Ovesco Endoscopy AG
Gastroenterology & Urology · 90d
Cleared Aug 11, 2022
InstaFill Graft Delivery System, SIGNIFY Bioactive
K221737 · FMF
Globus Medical, Inc.
General & Plastic Surgery · 57d
Cleared Aug 11, 2022
Arthrex Knotless FiberTak Biceps Suture Anchor
K222161 · MBI
Arthrex, Inc.
Orthopedic · 22d
Cleared Aug 11, 2022
TERA HARZ DENTURE
K222414 · EBI
Graphy, Inc.
Dental · 1d
Cleared Aug 10, 2022
BLT Dental Implant System
K212364 · DZE
Bio Concept Co., Ltd.
Dental · 376d
Cleared Aug 10, 2022
UniVit HE, UniVit UHS
K212763 · HQE
Visioncare Devices, LLC
Ophthalmic · 344d
Cleared Aug 10, 2022
CytonPro-5000
K213524 · ILY
Cytonsys, Inc.
Physical Medicine · 280d
Cleared Aug 10, 2022
iSyncWave
K220056 · GWQ
iMediSync, Inc.
Neurology · 216d
Cleared Aug 10, 2022
Safety Blood Collection Needles with/without Needle Holder
K220900 · JKA
Anhui Hongyu Wuzhou Medical...
General Hospital · 135d
Cleared Aug 10, 2022
KDG Abutments
K221381 · NHA
Keystone Dental, Inc.
Dental · 89d
Cleared Aug 10, 2022
Patient Monitor, models LM-8, LM-10, LM-12 and LM-15
K221879 · MHX
Caf Medical Solutions, Inc.
Cardiovascular · 43d
Cleared Aug 09, 2022
Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue,...
K212482 · LYY
Sri Trang Gloves (Thailand) Public...
General Hospital · 365d
Cleared Aug 09, 2022
NOVA RESIN dual cure, self adhesive resin cement
K213609 · EMA
Imicryl Dis Malzemeleri Sanayi VE...
Dental · 267d
Cleared Aug 09, 2022
IMICRYL Composite, Composite Flow Materials
K220077 · EBF
Imicryl Dis Malzemeleri Sanayi VE...
Dental · 211d
Cleared Aug 09, 2022
“POINT” Kinguide Robotic-Assisted Surgical System
K220241 · OLO
Point Robotics MedTech, Inc.
Orthopedic · 193d
Cleared Aug 09, 2022
NextGen Pedicle Screw System
K221776 · NKB
Corelink, LLC
Orthopedic · 49d
Cleared Aug 09, 2022
IRIS Pi Q switched Nd YAG laser
K221789 · GEX
Bio-Med USA, Inc.
General & Plastic Surgery · 49d
Cleared Aug 09, 2022
LimFlow V-Ceiver
K222083 · MMX
LimFlow, Inc.
Cardiovascular · 25d
Cleared Aug 09, 2022
DenMat Glutaraldehyde Desensitizer
K222357 · KLE
Denmat Holding, LLC
Dental · 5d
Cleared Aug 08, 2022
Dasky Disposable Sampling Tube (Model name: VSM02)
K211675 · QBD
Ningbo Dasky Life Science Co., Ltd.
Microbiology · 433d
Cleared Aug 08, 2022
VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL)
K212243 · LON
bioMerieux, Inc.
Microbiology · 385d
Cleared Aug 08, 2022
ClearPoint Maestro Brain Model
K213645 · QIH
ClearPoint Neuro, Inc.
Radiology · 263d