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
6769–6792 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 23, 2024
dima Print Teeth & Temp
K233868 · EBG
Kulzer, LLC
Dental · 169d
Cleared May 23, 2024
NOxBOXi Nitric Oxide Delivery System
K233251 · MRN
Linde Gas & Equipment, Inc.
Anesthesiology · 238d
Cleared May 23, 2024
CWM-930S, FIXER DV9
K233120 · GEI
Chungwoo Co., Ltd.
General & Plastic Surgery · 239d
Cleared May 23, 2024
VinDr-Mammo
K233108 · QFM
Vinbigdata Joint Stock Company
Radiology · 239d
Cleared May 23, 2024
AirKEE T900
K232642 · FRA
Healkee Medical Pte, Ltd.
General Hospital · 267d
Cleared May 23, 2024
CamAPS FX
K232603 · QJI
Camdiab , Ltd.
Chemistry · 269d
Cleared May 23, 2024
3DMatrix Surgical Mesh
K232602 · OXF
Printbio, Inc.
General & Plastic Surgery · 269d
Cleared May 22, 2024
Materialise Shoulder System™, Materialise Shoulder Guide and Models,...
K241143 · QHE
Materialise NV
Orthopedic · 27d
Cleared May 22, 2024
OviTex PRS
K241126 · FTM
TELA Bio, Inc.
General & Plastic Surgery · 29d
Cleared May 22, 2024
Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C, T15A,...
K241106 · OHT
Shenzhen Mlay Intelligent Technology...
General & Plastic Surgery · 30d
Cleared May 22, 2024
Rapid Urine Fentanyl (FYL) Test Strip
K241100 · NGL
Co-Innovation Biotech Co., Ltd.
Toxicology · 30d
Cleared May 22, 2024
Biomet Kirschner Wires (K-Wires)
K241014 · HTY
Biomet, Inc.
Orthopedic · 40d
Cleared May 22, 2024
Bosley Booster 128 Laser Cap
K240456 · OAP
Plm Worldwide, LLC D/B/A Phoenix...
General & Plastic Surgery · 97d
Cleared May 22, 2024
Zenition 90
K240224 · OWB
Philips Medical Systems Nederlands B.V.
Radiology · 117d
Cleared May 22, 2024
IntraOp Alignment System
K240199 · OWB
Alphatec Spine, Inc.
Radiology · 118d
Cleared May 22, 2024
Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)
K240097 · QSY
Ushare Medical, Inc.
General & Plastic Surgery · 131d
Cleared May 22, 2024
INUMI™ Flex Needle
K233884 · OAB
Galvanize Therapeutics, Inc.
General & Plastic Surgery · 166d
Cleared May 22, 2024
Fogarty Arterial Embolectomy Catheter with Gate Valve
K233820 · DXE
Edwards Lifesciences
Cardiovascular · 173d
Cleared May 22, 2024
Fogarty Venous Thrombectomy Catheters
K233819 · DXE
Edwards Lifesciences, LLC
Cardiovascular · 173d
Cleared May 22, 2024
Impress Angiographic Catheter
K233268 · DQO
Merit Medical Systems, Inc.
Cardiovascular · 236d
Cleared May 22, 2024
Gladiator
K233099 · GEI
Rohrer Aesthetics, LLC
General & Plastic Surgery · 239d
Cleared May 22, 2024
Paltop Short Implants
K232740 · DZE
Paltop Advanced Dental Solutions, Ltd.
Dental · 258d
Cleared May 22, 2024
Bonvadis®
K232655 · FRO
Stemcyte, Inc.
General & Plastic Surgery · 265d
Cleared May 21, 2024
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A...
K241110 · OZE
Centers For Disease Control and...
Microbiology · 29d