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
10129–10152 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 10, 2023
Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032,...
K222870 · NUH
Shenzhen Kentro Medical Electronics...
Neurology · 230d
Cleared May 10, 2023
Sientra, inc. Portfinder
K221127 · LCJ
Sientra, Inc.
General & Plastic Surgery · 387d
Cleared May 10, 2023
Neurophet AQUA
K220437 · LLZ
Neurophet., Inc.
Radiology · 448d
Cleared May 09, 2023
ATEC Lateral Plate System
K230721 · KWQ
Alphatec Spine, Inc.
Orthopedic · 55d
Cleared May 09, 2023
Tens & Ems Device
K223825 · NUH
Shenzhen Jian Feng Electronic...
Physical Medicine · 139d
Cleared May 09, 2023
Catalyst R1 Reverse Shoulder System
K223655 · PHX
Catalyst Orthoscience, Inc.
Orthopedic · 154d
Cleared May 09, 2023
SIRION Lateral Lumbar Interbody System
K223335 · MAX
Astura Medical
Orthopedic · 189d
Cleared May 09, 2023
Tyvek Roll with CI for STERLINK Sterilizer
K223025 · FRG
Plasmapp Co,., Ltd.
General Hospital · 222d
Cleared May 09, 2023
Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators...
K223023 · FRC
Plasmapp Co,., Ltd.
General Hospital · 222d
Cleared May 09, 2023
STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette
K223015 · MLR
Plasmapp Co,., Ltd.
General Hospital · 222d
Cleared May 09, 2023
CX50N
K222719 · PGY
Wide Corporation
Radiology · 243d
Cleared May 09, 2023
Retitrack
K222484 · HLL
C. Light Technologies, Inc.
Ophthalmic · 265d
Cleared May 09, 2023
Latitud™ Hip Replacement System
K222436 · LPH
Meril Healthcare Pvt. , Ltd.
Orthopedic · 270d
Cleared May 09, 2023
Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for...
K212857 · FMF
Jiangsu Zhiyu Medical Instrument Co,...
General Hospital · 608d
Cleared May 08, 2023
JO Water Based Anal Thick Lubricant 2oz Model 40112, JO Water Based Anal...
K230674 · NUC
CC Wellness, LLC
Obstetrics & Gynecology · 59d
Cleared May 08, 2023
Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A,...
K223428 · NUH
Shenzhen Leqing Medical Instrument...
Neurology · 175d
Cleared May 08, 2023
Disposible Nitrile Gloves
K223280 · LZA
Holik Asia Group Co.,Ltd
General Hospital · 196d
Cleared May 08, 2023
MX50N
K222716 · PGY
Wide Corporation
Radiology · 242d
Cleared May 08, 2023
Anika Tissue Tack Fixation System
K222487 · GDW
Anika Therapeutics, Inc.
General & Plastic Surgery · 264d
Cleared May 05, 2023
Panther Fusion AdV/hMPV/RV Assay
K231017 · OCC
Hologic, Inc.
Microbiology · 25d
Cleared May 05, 2023
Rod Registration Frame
K230989 · OLO
Nu Vasive, Incorporated
Orthopedic · 29d
Cleared May 05, 2023
Wattson temporary pacing guidewire (2250)
K230637 · DQX
Vascular Solutions, LLC
Cardiovascular · 59d
Cleared May 05, 2023
Polyguard and Polyshield Safety IV Catheters
K230616 · FOZ
Poly Medicure Limited
General Hospital · 60d
Cleared May 05, 2023
Electric Scooter (Model: S3312)
K230615 · INI
Guangdong Prestige Technology Co., Ltd.
Physical Medicine · 60d