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
12265–12288 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 12, 2022
Rapid ICH
K221456 · QAS
Ischemaview, Inc.
Radiology · 116d
Cleared Sep 12, 2022
Plasma Shield
K221533 · GCJ
Plasmatica, Ltd.
General & Plastic Surgery · 108d
Cleared Sep 12, 2022
KOLO Evolution XHD Series Ultrasound Diagnostic System
K221568 · IYN
Kolo Medical (Suzhou) Co., Ltd.
Radiology · 104d
Cleared Sep 12, 2022
Integrity-SI Fusion System
K222512 · OUR
OsteoCentric Technologies
Orthopedic · 24d
Cleared Sep 09, 2022
Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set,...
K213244 · ELW
Prevest Denpro Limited
Dental · 344d
Cleared Sep 09, 2022
MICOR Lens Fragmentation System
K214028 · HQC
Carl Zeiss Meditec Cataract...
Ophthalmic · 261d
Cleared Sep 09, 2022
Dexus Prosthetics System (Model: MSL1, MSR1)
K220002 · GXY
Zhejiang Qiangnao Technology Co.,Ltd
Neurology · 248d
Cleared Sep 09, 2022
AUTOBAHN(R) EVO Femoral Nails
K220659 · HSB
Globus Medical, Inc.
Orthopedic · 186d
Cleared Sep 09, 2022
Powder Free Nitrile Examination Gloves, Colored (Green, Orange, Purple,...
K220859 · LZA
Careglove Global Sdn. Bhd.
General Hospital · 169d
Cleared Sep 09, 2022
PointCore Surgical Mask
K220944 · FXX
Pointcore, Inc.
General Hospital · 162d
Cleared Sep 09, 2022
Arthrex SutureTape
K221354 · GAT
Arthrex, Inc.
General & Plastic Surgery · 122d
Cleared Sep 09, 2022
NuVasive Reline Cervical System
K221388 · NKG
Nu Vasive, Incorporated
Orthopedic · 119d
Cleared Sep 09, 2022
V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature...
K222093 · MLR
Steris
General Hospital · 56d
Cleared Sep 09, 2022
Ellusa Reusable Bipolar Cable
K222429 · GEI
Ellusa, LLC
General & Plastic Surgery · 29d
Cleared Sep 09, 2022
Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE...
K222440 · FRG
Steris
General Hospital · 28d
Cleared Sep 09, 2022
AMBARINO High-Class
K222723 · EBF
Creamed GmbH & Co. Produktions- Und...
Dental · 1d
Cleared Sep 08, 2022
MammaPrint FFPE NGS Kit
K210973 · NYI
Agendia, Inc.
Pathology · 526d
Cleared Sep 08, 2022
Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light...
K211648 · DFH
Diazyme Laboratories, Inc.
Immunology · 468d
Cleared Sep 08, 2022
Dynamis Pro Family
K213267 · GEX
Fotona D.O.O.
General & Plastic Surgery · 343d
Cleared Sep 08, 2022
Ultrasonic Endo Activation Device (Model:Actor I pro)
K213947 · ELC
Changzhou Bomedent Medical Technology...
Dental · 265d
Cleared Sep 08, 2022
Cranial EM System
K213989 · HAW
Brainlab AG
Neurology · 262d
Cleared Sep 08, 2022
BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens
K220143 · LPL
Shenzhen Dashicheng Optical...
Ophthalmic · 233d
Cleared Sep 08, 2022
Soundly Anti Snoring Device
K220330 · LRK
Greystone Ip, Ltd.
Dental · 216d
Cleared Sep 08, 2022
NeoNavia Biopsy System
K220595 · KNW
Neodynamics AB
General & Plastic Surgery · 191d