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
6769–6792 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 21, 2024
Single-Use Video Flexible Cystoscope (RP-U-C0201/RP-U-C0201S)
K240663 · FAJ
Guangzhou Red Pine Medical Instrument...
Gastroenterology & Urology · 105d
Cleared Jun 21, 2024
Ice Cooling IPL Hair Removal Device (UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07...
K240649 · OHT
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 106d
Cleared Jun 21, 2024
MissLan® Early Detection Pregnancy Test Strip
K240643 · LCX
Guangzhou Decheng Biotechnology Co.,...
Chemistry · 106d
Cleared Jun 21, 2024
V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System
K240631 · IYN
Samsung Medison Co., Ltd.
Radiology · 107d
Cleared Jun 21, 2024
O-arm O2 Imaging System
K240465 · OWB
Medtronic Navigation, Inc.
Radiology · 126d
Cleared Jun 21, 2024
MINAMO blue
K240387 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 134d
Cleared Jun 21, 2024
Therm-X (Home)
K240125 · JOW
Zenith Technical Innovations
Cardiovascular · 157d
Cleared Jun 21, 2024
Nimbl (model PD08-N1)
K234155 · JOW
Tactile Medical
Cardiovascular · 175d
Cleared Jun 21, 2024
OtoNova/OtoNova Pro
K234095 · EWO
Otodynamics
Ear, Nose, Throat · 178d
Cleared Jun 21, 2024
rainbow Paste Stain SE
K233885 · EIH
Genoss Co., Ltd.
Dental · 196d
Cleared Jun 21, 2024
UNITY VCS (8065000296)
K233876 · HQC
Alcon Laboratories, Inc.
Ophthalmic · 197d
Cleared Jun 21, 2024
Tempus ECG-AF
K233549 · SBQ
Tempus AI, Inc.
Cardiovascular · 231d
Cleared Jun 21, 2024
Sunny Cup and Applicator
K233361 · HHE
Menstrual Mates
Obstetrics & Gynecology · 266d
Cleared Jun 21, 2024
Merge Hemo, Model RCSV2
K233326 · DQK
Merge Healthcare Incorporated
Cardiovascular · 266d
Cleared Jun 21, 2024
Mochida Nerve Cuff
K233322 · JXI
Mochida Pharmaceutical Co., Ltd.
Neurology · 266d
Cleared Jun 21, 2024
SteadyTemp
K233280 · FLL
Steadysense GmbH
General Hospital · 266d
Cleared Jun 21, 2024
Xerosyn
K233259 · MQV
Xerothera, Inc.
Orthopedic · 266d
Cleared Jun 21, 2024
eCARTv5 Clinical Deterioration Suite (“eCART”)
K233253 · QNL
Agilemd, Inc.
Cardiovascular · 267d
Cleared Jun 21, 2024
GERDX-System
K233240 · ODE
G-Surg GmbH
Gastroenterology & Urology · 267d
Cleared Jun 21, 2024
See Factor CT3™
K233230 · OWB
Epica International, Inc.
Radiology · 267d
Cleared Jun 21, 2024
Medihub Prostate
K233196 · QIH
JLK, Inc.
Radiology · 267d
Cleared Jun 21, 2024
PRESSUREALERT® Pressure Monitoring System
K233096 · SBO
Position Health, LLC
General Hospital · 269d
Cleared Jun 21, 2024
Pulse Oximeter (MD300C228)
K232975 · DQA
Beijing Choice Electronic Technology...
Anesthesiology · 274d
Cleared Jun 21, 2024
Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869)
K232807 · FXX
Owens & Minor (O&M) Halyard, Inc.
General Hospital · 283d