FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
8809–8832 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 26, 2023
Luja Coude (20108 Male CH18 - large packaging)
K233101 · EZD
Coloplast Corp.
Gastroenterology & Urology · 30d
Cleared Oct 26, 2023
Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT)
K233091 · KFM
Qura S.R.L
Cardiovascular · 30d
Cleared Oct 26, 2023
Lumify Diagnostic Ultrasound System
K232500 · IYN
Philips Ultrasound
Radiology · 70d
Cleared Oct 26, 2023
SIMDA abutment
K232271 · NHA
Simda Co., Ltd.
Dental · 87d
Cleared Oct 26, 2023
ANAX™ 5.5 Spinal System
K231737 · NKB
Innosys Co., Ltd.
Orthopedic · 134d
Cleared Oct 26, 2023
TE Air Diagnostic Ultrasound System
K231685 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 139d
Cleared Oct 26, 2023
Electric Breast Pump
K231595 · HGX
Shenzhen Changkun Technology Co., Ltd.
Obstetrics & Gynecology · 147d
Cleared Oct 26, 2023
MOLLI 2
K231579 · NEU
Molli Surgical, Inc.
General & Plastic Surgery · 148d
Cleared Oct 26, 2023
Sontro® OTC Hearing Aids (AI)
K231550 · QUH
Soundwave Hearing, LLC
Ear, Nose, Throat · 149d
Cleared Oct 26, 2023
Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs,...
K230662 · LZA
Zhonghong Pulin Medical Products Co.,...
General Hospital · 230d
Cleared Oct 26, 2023
Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230),...
K230559 · BTT
Medline Industries, Inc.
Anesthesiology · 240d
Cleared Oct 26, 2023
Air Compression Therapy Recovery System (model: MF-AWI, MF-AWI.LED.A-801,...
K230500 · IRP
Jiangsu Maxf Electric Appliance Co.,...
Physical Medicine · 244d
Cleared Oct 26, 2023
NIM Standard Reinforced EMG Endotracheal Tube
K230320 · ETN
Medtronic Xomed, Inc.
Ear, Nose, Throat · 262d
Cleared Oct 26, 2023
Antimicrobial Gelling Fiber Dressing with PHMB
K213473 · FRO
Advanced Medical Solutions, Ltd.
General & Plastic Surgery · 728d
Cleared Oct 25, 2023
sam CS Long Duration Ultrasound Device
K233210 · PFW
ZetrOZ Systems, LLC
Physical Medicine · 27d
Cleared Oct 25, 2023
PiXel8-RF
K233147 · GEI
Rohrer Aesthetics
General & Plastic Surgery · 28d
Cleared Oct 25, 2023
ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L,...
K233113 · KNS
Starmed Co., Ltd.
Gastroenterology & Urology · 28d
Cleared Oct 25, 2023
Balanced Knee® System TriMax PS Plus Tibial Insert
K233093 · JWH
Ortho Development Corporation
Orthopedic · 29d
Cleared Oct 25, 2023
Rapid SDH
K232436 · QAS
Ischemaview, Inc.
Radiology · 72d
Cleared Oct 25, 2023
Magstim®Horizon® 3.0 TMS Therapy System
K232235 · OBP
The Magstim Company , Ltd.
Neurology · 90d
Cleared Oct 25, 2023
AcuityUDR
K231995 · KPR
Radmedix, LLC
Radiology · 112d
Cleared Oct 25, 2023
POWERSEAL Sealer and Divider
K231327 · GEI
Gyrus Acmi, Inc.
General & Plastic Surgery · 170d
Cleared Oct 25, 2023
PERLA® TL Posterior Thoraco-lumbar Fixation System
K231069 · NKB
Spineart SA
Orthopedic · 194d
Cleared Oct 25, 2023
SignalHF (IM008)
K230842 · QNL
Implicity, Inc.
Cardiovascular · 211d