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
11665–11688 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 11, 2022
Mapping Suction Probe
K212164 · ETN
Inomed Medizintechnik GmbH
Neurology · 487d
Cleared Nov 11, 2022
ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System
K220983 · IYN
Imsonic Medical China, Inc.
Radiology · 221d
Cleared Nov 11, 2022
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs...
K222225 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 109d
Cleared Nov 10, 2022
APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima...
K211934 · FAD
Boston Scientific Corporation
Gastroenterology & Urology · 506d
Cleared Nov 10, 2022
Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid,...
K211954 · GYC
Spes Medica Srl
Neurology · 505d
Cleared Nov 10, 2022
Dermal Cooling System
K213294 · QPZ
R2 Technologies, Inc.
General & Plastic Surgery · 405d
Cleared Nov 10, 2022
AMSure Enteral Feeding Pump
K220230 · LZH
Amsino International, Inc.
General Hospital · 287d
Cleared Nov 10, 2022
Tandry CMF Plate System
K220360 · JEY
Microware Precision Co., Ltd.
Dental · 275d
Cleared Nov 10, 2022
AVIEW RT ACS
K220408 · QKB
Coreline Soft Co., Ltd.
Radiology · 269d
Cleared Nov 10, 2022
TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment
K220562 · NHA
Megagen Implant Co., Ltd.
Dental · 255d
Cleared Nov 10, 2022
10PL
K220794 · ONF
Tentech Co. , Ltd.
General & Plastic Surgery · 237d
Cleared Nov 10, 2022
FUJIFILM Endoscope Model EB-710P
K220957 · EOQ
Fujifilm Corporaton
Ear, Nose, Throat · 223d
Cleared Nov 10, 2022
Bodygard SFS Surgical Gown Level 4
K221139 · FYA
Feliks Plastik Laminasyon VE Ambalaj...
General Hospital · 205d
Cleared Nov 10, 2022
AEYE-DS
K221183 · PIB
Aeye Health, Inc.
Ophthalmic · 199d
Cleared Nov 10, 2022
Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer
K221225 · JLW
Beckman Coulter, Inc.
Chemistry · 196d
Cleared Nov 10, 2022
WOLF Thrombectomy™ SmartClaw Catheter
K221391 · QEW
Devoro Medical, Inc.
Cardiovascular · 181d
Cleared Nov 10, 2022
Synapse 3D Base Tools v6.6
K221677 · LLZ
Fujifilm Corporation
Radiology · 154d
Cleared Nov 10, 2022
SprintRay High Impact Denture Base
K221678 · EBI
Sprintray, Inc.
Dental · 154d
Cleared Nov 10, 2022
Dental LT Clear V2 Resin
K222061 · MQC
Formlabs Ohio, Inc.
Dental · 120d
Cleared Nov 10, 2022
SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set
K222067 · KDI
Quanta Dialysis Technologies, Ltd.
Gastroenterology & Urology · 120d
Cleared Nov 10, 2022
Catalyst EA Convertible Stemmed Shoulder
K222317 · KWS
Catalyst Orthoscience, Inc.
Orthopedic · 100d
Cleared Nov 10, 2022
SNOR LOCK
K222475 · LRK
Solbaro Co., Ltd.
Dental · 86d
Cleared Nov 10, 2022
H1
K222504 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 84d
Cleared Nov 10, 2022
Humask Pro Vision, Humask Pro Vision 3000
K222551 · FXX
Entreprise Premont, Inc.
General Hospital · 79d