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
7081–7104 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 17, 2024
TraumaGuard Intra-abdominal Pressure Sensing System
K240057 · EZL
Sentinel Medical Technologies, LLC
Gastroenterology & Urology · 100d
Cleared Apr 17, 2024
Enteral Feeding Sets
K240039 · KNT
Hangzhou Primecare Medical Co., Ltd.
Gastroenterology & Urology · 103d
Cleared Apr 17, 2024
Celerity Chemical Indicator for enspire 3000 CLCSPS
K240032 · JOJ
STERIS Corporation
General Hospital · 104d
Cleared Apr 17, 2024
TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET...
K233863 · HRS
TriMed, Inc.
Orthopedic · 133d
Cleared Apr 17, 2024
uOmnispace.MR
K233186 · QIH
Shanghai United Imaging Healthcare...
Radiology · 202d
Cleared Apr 17, 2024
Goyo Mouthpiece S
K232238 · OBR
Dimedikorea
Dental · 264d
Cleared Apr 17, 2024
Carilex VT¿200-i NX
K231646 · OMP
Carilex Medical, Inc.
General & Plastic Surgery · 317d
Cleared Apr 16, 2024
nextaro® v, 20/20
K240748 · LHI
Sfm Medical Devices GmbH
General Hospital · 28d
Cleared Apr 16, 2024
ReBorn (1050nm)
K233962 · PKT
Lightfective , Ltd.
General & Plastic Surgery · 123d
Cleared Apr 16, 2024
Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2
K233886 · FDT
Ambu A/S
Gastroenterology & Urology · 130d
Cleared Apr 16, 2024
Alcantara Thoracolumbar Plate System
K232256 · KWQ
Camber Spine Technologies, LLC
Orthopedic · 263d
Cleared Apr 16, 2024
Sectra Digital Pathology Module (Version 3.3)
K232208 · PSY
Sectra AB
Pathology · 265d
Cleared Apr 16, 2024
Aperio GT 450 DX
K232202 · PSY
Leica Biosystems Imaging, Inc.
Pathology · 266d
Cleared Apr 16, 2024
Co2 Laser System, Models: PureLase And VanLase
K232133 · GEX
Cpmt Laser (Canadian Pioneer Medical...
General & Plastic Surgery · 273d
Cleared Apr 15, 2024
Glide (91000-GL-X)
K240884 · GXY
Infinite Biomedical Technologies, LLC
Neurology · 14d
Cleared Apr 15, 2024
VisAble.IO
K240773 · QTZ
Techsomed
Radiology · 25d
Cleared Apr 15, 2024
Ez Catch Auto
K240205 · GCJ
Veol Medical Technologies Pvt , Ltd.
General & Plastic Surgery · 81d
Cleared Apr 15, 2024
Folysil Silicone Catheter
K233411 · EZL
Coloplast Corp.
Gastroenterology & Urology · 192d
Cleared Apr 15, 2024
Novalung ultimate kit (US)
K232926 · QJZ
Fresenius Medical Care Renal...
Cardiovascular · 208d
Cleared Apr 15, 2024
Access Ostase
K232904 · CIN
Beckman Coulter
Chemistry · 210d
Cleared Apr 15, 2024
Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM...
K223113 · NHA
Medentika GmbH
Dental · 560d
Cleared Apr 14, 2024
XN Knee Prosthesis System
K232175 · JWH
Beijing Chunlizhengda Medical...
Orthopedic · 268d
Cleared Apr 12, 2024
Fine Osteotomy™
K240703 · HRS
Bodycad Laboratories, Inc.
Orthopedic · 29d
Cleared Apr 12, 2024
Healgen Accurate Urine Drug Screen Dip Card
K240686 · NGL
Healgen Scientific, LLC
Toxicology · 31d