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
9409–9432 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 28, 2023
3 Layer Surgical Mask (134252531)
K231618 · FXX
Original Mattress Factory, Inc.
General Hospital · 56d
Cleared Jul 28, 2023
Blood Tubing Lines for Hemodialysis AV06C-E
K231589 · KOC
NIKKISO CO., LTD.
Gastroenterology & Urology · 57d
Cleared Jul 28, 2023
Dia-Cem
K231552 · EMA
DiaDent Group International
Dental · 59d
Cleared Jul 28, 2023
Bright MTA Sealer Plus
K231480 · KIF
Genoss Co., Ltd.
Dental · 67d
Cleared Jul 28, 2023
Therapy Mask 3100 NC/SP
K231313 · BZD
Respironics, Inc.
Anesthesiology · 84d
Cleared Jul 28, 2023
PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI...
K231249 · PEA
Pentax of America, Inc.
Gastroenterology & Urology · 88d
Cleared Jul 28, 2023
SkinStylus SteriLock® MicroSystem, Model Number MP1209SL
K231073 · QAI
Esthetic Medical, Inc.
General & Plastic Surgery · 105d
Cleared Jul 28, 2023
FLUOBEAM® LX Red
K230898 · QDG
Fluoptics Sas
General & Plastic Surgery · 119d
Cleared Jul 28, 2023
BlueStar and BlueStar Rx
K230813 · NDC
Welldoc, Inc.
Chemistry · 126d
Cleared Jul 28, 2023
Pathfinder Endoscope Overtube with Balloon Device
K230801 · FED
Neptune Medical, Inc.
Gastroenterology & Urology · 127d
Cleared Jul 28, 2023
Quantisal™ II Oral Fluid Collection Device
K223781 · PJD
Immunalysis Corporation
Chemistry · 224d
Cleared Jul 28, 2023
i-STAT CG8+ cartridge with the i-STAT 1 System
K223710 · CGA
Abbott Point of Care, Inc.
Chemistry · 228d
Cleared Jul 28, 2023
MESI mTablet ECG Diagnostic System, MESI mTablet ECG
K223670 · DPS
Mesi, Development of Medical Devices,...
Cardiovascular · 233d
Cleared Jul 28, 2023
Electrocardiograph: SE-1200 Pro and SE-1201 Pro
K222902 · DPS
Edan Instruments, Inc.
Cardiovascular · 308d
Cleared Jul 28, 2023
FlowStar Touch Digital Mixer Flowmeter
K222794 · BZR
Baldus Sedation GmbH & Co. KG
Anesthesiology · 315d
Cleared Jul 28, 2023
HJY VisualNext Endoscopic Vision System
K222735 · GWG
Hjy Smart Medical Device Co., Ltd.
Neurology · 322d
Cleared Jul 28, 2023
PatCom Distal Chip Endoscope
K222587 · EOB
H&A Mui Enterprises, Inc.
Ear, Nose, Throat · 336d
Cleared Jul 27, 2023
Therm-X
K231912 · IRP
Zenith Technical Innovations
Physical Medicine · 28d
Cleared Jul 27, 2023
SURGIVISIO Device
K231886 · OLO
Ecential Robotics
Orthopedic · 30d
Cleared Jul 27, 2023
LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))
K231555 · OHS
iSMART Developments, Ltd.
General & Plastic Surgery · 58d
Cleared Jul 27, 2023
Altaviz Needle Kit II
K231261 · FMI
Altaviz, LLC
General Hospital · 87d
Cleared Jul 27, 2023
IBS-B MIS Beveled Screw System
K231236 · HWC
In2bones USA, LLC
Orthopedic · 90d
Cleared Jul 27, 2023
MDx-Chex for BC-GN
K231223 · PMN
Streck
Microbiology · 90d
Cleared Jul 27, 2023
MDx-Chex for BC-GP
K231221 · PMN
Streck
Microbiology · 90d