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
10417–10440 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 09, 2023
ATEC Lateral Plate System
K230721 · KWQ
Alphatec Spine, Inc.
Orthopedic · 55d
Cleared May 08, 2023
Anika Tissue Tack Fixation System
K222487 · GDW
Anika Therapeutics, Inc.
General & Plastic Surgery · 264d
Cleared May 08, 2023
MX50N
K222716 · PGY
Wide Corporation
Radiology · 242d
Cleared May 08, 2023
Disposible Nitrile Gloves
K223280 · LZA
Holik Asia Group Co.,Ltd
General Hospital · 196d
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
JO Water Based Anal Thick Lubricant 2oz Model 40112, JO Water Based Anal...
K230674 · NUC
CC Wellness, LLC
Obstetrics & Gynecology · 59d
Cleared May 05, 2023
ELEC Master, ELEC Master Dual
K202963 · EIA
Mgnewton , Ltd.
Dental · 947d
Cleared May 05, 2023
ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA...
K220781 · EZN
Allwin Medical Devices, Inc.
Gastroenterology & Urology · 414d
Cleared May 05, 2023
Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses
K221768 · HQD
Paragon Vision Sciences, Inc.
Ophthalmic · 322d
Cleared May 05, 2023
Arm Blood Pressure Monitor, Model Name:111, Arm Blood Pressure Monitor, Model...
K222926 · DXN
Shenzhen Yuezhongxing Technology Co.,...
Cardiovascular · 221d
Cleared May 05, 2023
Lexa MINI (RIS-303, RIS-305)
K223858 · FLE
W&H Sterilization S.R.L.
General Hospital · 133d
Cleared May 05, 2023
LED Facial Mask
K230351 · OHS
Shenzhen Sungpo Hi-Tech Electronic...
General & Plastic Surgery · 85d
Cleared May 05, 2023
Electric Scooter (Model: S3312)
K230615 · INI
Guangdong Prestige Technology Co., Ltd.
Physical Medicine · 60d
Cleared May 05, 2023
Polyguard and Polyshield Safety IV Catheters
K230616 · FOZ
Poly Medicure Limited
General Hospital · 60d
Cleared May 05, 2023
Wattson temporary pacing guidewire (2250)
K230637 · DQX
Vascular Solutions, LLC
Cardiovascular · 59d
Cleared May 05, 2023
Rod Registration Frame
K230989 · OLO
Nu Vasive, Incorporated
Orthopedic · 29d
Cleared May 05, 2023
Panther Fusion AdV/hMPV/RV Assay
K231017 · OCC
Hologic, Inc.
Microbiology · 25d
Cleared May 04, 2023
Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit,...
K203245 · MMW
Nucleix , Ltd.
Medical Genetics · 912d
Cleared May 04, 2023
BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application,...
K213280 · QQY
Bd Kiestra B.V.
Microbiology · 580d
Cleared May 04, 2023
Revitalair 430+
K220290 · CBF
Us Hyperbaric Network
Anesthesiology · 457d
Cleared May 04, 2023
Pollogen STOP U Model UXV Device
K220322 · PAY
Pollogen, Ltd.
General & Plastic Surgery · 455d
Cleared May 04, 2023
Sol-Guard Auto-disable Syringe
K220713 · FMF
Sol-Millennium Medical, Inc.
General Hospital · 419d
Cleared May 04, 2023
Finger Pulse Oximeter, Model: X1906P
K221798 · DQA
Shenzhen Changkun Technology Co., Ltd.
Anesthesiology · 317d
Cleared May 04, 2023
OLYMPIC Deformity Band System
K222097 · OWI
Astura Medical
Orthopedic · 290d