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
2257–2280 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 20, 2025
brAIn™ Shoulder Positioning
K252665 · QIH
Avatar Medical
Radiology · 56d
Cleared Oct 20, 2025
VereSee Optical Veres Needle and Endoscopic Camera
K252640 · GCJ
Freyja Healthcare, LLC
General & Plastic Surgery · 60d
Cleared Oct 20, 2025
Q-Switched Nd: YAG Laser machine (LFS-C13U)
K252319 · GEX
Sanhe?Lefis?Electronics?Co., Ltd.
General & Plastic Surgery · 87d
Cleared Oct 20, 2025
Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645)
K252277 · DSY
Vascular Flow Technologies Limited
Cardiovascular · 90d
Cleared Oct 20, 2025
AVAVA™ Skin Treatment System
K252155 · ONG
Avava, Inc.
General & Plastic Surgery · 103d
Cleared Oct 20, 2025
Miracu™ Polydioxanone (PDO) Suture and Needle (MONO)
K251414 · NEW
Feeltech Co., Ltd.
General & Plastic Surgery · 166d
Cleared Oct 20, 2025
A8 INTEGR8™ Porous Pedicle Screws
K242827 · NKB
Allumin8, Inc.
Orthopedic · 397d
Cleared Oct 17, 2025
S.I.N. Dental Implant System
K252266 · NHA
S.I.N. Implant System Ltda
Dental · 88d
Cleared Oct 17, 2025
MEGELIN LED Light Therapy Mask (JML1, JML1+JML2)
K252264 · OHS
Shenzhen Zhenxing Ruitong Technology...
General & Plastic Surgery · 88d
Cleared Oct 17, 2025
Osteotomy Wedge System
K252254 · PLF
Sinaptic Surgical
Orthopedic · 88d
Cleared Oct 17, 2025
Program insite® Powder-Free, Disposable Nitrile Exam Gloves
K252075 · LZA
Program Insite, LLC
General Hospital · 107d
Cleared Oct 17, 2025
InZone IST Detachment System
K251832 · HCG
Stryker Neurovascular
Neurology · 123d
Cleared Oct 17, 2025
Remi Custom Night Guard
K251778 · OBR
Remi
Dental · 129d
Cleared Oct 17, 2025
X9 Ultrasound System
K251673 · SGH
X9, Inc.
Gastroenterology & Urology · 140d
Cleared Oct 17, 2025
X1-FFR
K251355 · QHA
Spectrawave, Inc.
Radiology · 170d
Cleared Oct 17, 2025
StealthStation S8 Spine Software
K251282 · OLO
Medtronic Navigation, Inc.
Orthopedic · 176d
Cleared Oct 17, 2025
IntelliVue Patient monitors MX400, MX450, MX500, MX550
K251146 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 186d
Cleared Oct 17, 2025
Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series)
K250945 · KNS
Olympus Medical Systems Corp.
Gastroenterology & Urology · 203d
Cleared Oct 17, 2025
MOSkin Radiation Measurement System
K250911 · IYE
Electrogenics Labs, Ltd.
Radiology · 205d
Cleared Oct 17, 2025
ADVIA Centaur Anti-Thyroid Peroxidase II
K250250 · JZO
Siemens Healthcare Diagnostics, Inc.
Immunology · 262d
Cleared Oct 17, 2025
JOVS Electric Stimulation Beauty Device (JE2)
K250227 · NFO
Shenzhen Qianyu Technology Co., Ltd.
Neurology · 263d
Cleared Oct 17, 2025
SureAx-Guide™
K250203 · DQX
Sureax Medical, LLC
Cardiovascular · 266d
Cleared Oct 17, 2025
Estremo Fibular Nail
K250197 · HSB
Citieffe S.R.L.
Orthopedic · 267d
Cleared Oct 17, 2025
Adin Customized Abutments
K250178 · NHA
Adin Dental Implant Systems , Ltd.
Dental · 268d