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
8353–8376 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 16, 2023
MASADA Modular Spinal Fixation System
K231694 · NKB
Astura Medical
Orthopedic · 160d
Cleared Nov 16, 2023
D100 KIDS
K231652 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 163d
Cleared Nov 16, 2023
LINK Embrace Shoulder System - Reverse Configuration
K231445 · PHX
Waldemar Link GmbH & Co. KG
Orthopedic · 182d
Cleared Nov 16, 2023
Aptima® Chlamydia trachomatis Assay
K230451 · MKZ
Hologic, Inc.
Microbiology · 268d
Cleared Nov 15, 2023
Arthrex Knee FiberTak® Button Suture Anchor
K232973 · MBI
Arthrex, Inc.
Orthopedic · 55d
Cleared Nov 15, 2023
Axial3D Insight
K232841 · QIH
Axial Medical Printing Limited
Radiology · 62d
Cleared Nov 15, 2023
BinkieRT
K231852 · IYE
Papricalab
Radiology · 145d
Cleared Nov 15, 2023
METIC™- Airway Balloon Catheter
K231818 · KTI
M/S Meril Life Sciences Pvt. , Ltd.
Ear, Nose, Throat · 147d
Cleared Nov 15, 2023
CoolSeal Trinity
K231012 · GEI
Bolder Surgical, LLC
General & Plastic Surgery · 219d
Cleared Nov 15, 2023
NSite Scoliosis Assessment App
K230463 · LDK
Nsite, Inc.
Physical Medicine · 267d
Cleared Nov 15, 2023
Curing Light, Model: MaxCure 9
K223414 · EBZ
Guilin Refine Medical Instrument Co.,...
Dental · 370d
Cleared Nov 14, 2023
Iconix Anchor
K233468 · MBI
Riverpoint Medical
Orthopedic · 21d
Cleared Nov 14, 2023
Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG)
K233434 · LRK
Prismatik Dentalcraft, Inc.
Dental · 32d
Cleared Nov 14, 2023
IPL Cooling Hair Removal Device
K232845 · OHT
Shenzhen Siken 3D Technology...
General & Plastic Surgery · 61d
Cleared Nov 14, 2023
BLU TOTALE (Model: ENEOB852)
K232656 · OLP
Premier North America, Inc.
General & Plastic Surgery · 75d
Cleared Nov 14, 2023
MAGNETOM Avanto fit
K232494 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 89d
Cleared Nov 14, 2023
Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for...
K232461 · LZA
Kossan International Sdn Bhd
General Hospital · 91d
Cleared Nov 14, 2023
Great Basin Toxigenic C. difficile Direct Test (CDF2)
K232092 · OZN
Vela Operations USA
Microbiology · 124d
Cleared Nov 14, 2023
saremco print BRIDGETEC
K232050 · EBF
Saremco Dental AG
Dental · 127d
Cleared Nov 14, 2023
VitroPRO
K231783 · ITX
CIVCO Medical Instruments Co., Inc.
Radiology · 151d
Cleared Nov 14, 2023
UniPearls® Embolic Microspheres
K231554 · KRD
Suzhou Haowei Medical Technology Co.,...
Gastroenterology & Urology · 168d
Cleared Nov 14, 2023
Broncho Videoscope System
K231521 · EOQ
Scivita Medical Technology Co., Ltd.
Ear, Nose, Throat · 172d
Cleared Nov 14, 2023
Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow,...
K231097 · NHA
Prismatik Dentalcraft, Inc.
Dental · 210d
Cleared Nov 14, 2023
QScout Lab
K230878 · GKZ
Ad Astra Diagnostics, Inc.
Hematology · 229d