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
10345–10368 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 17, 2023
Radiation Planning Assistant (RPA)
K222728 · MUJ
University of Texas, MD Anderson...
Radiology · 251d
Cleared May 17, 2023
Biodegradable Nitrile Powder Free Examination Glove Tested for Use with...
K223437 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 184d
Cleared May 17, 2023
F&P Solo Mask Range
K223696 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 159d
Cleared May 17, 2023
Assert-IQ™ Insertable Cardiac Monitor
K230286 · MXC
Abbott Medical
Cardiovascular · 104d
Cleared May 17, 2023
DeepX DermoSight Dermatoscope
K230448 · PSN
Deepx Health, LLC
General & Plastic Surgery · 85d
Cleared May 17, 2023
Symbia Pro.specta VA20A Family
K231102 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared May 17, 2023
JuggerKnot Soft Anchor
K231128 · MBI
Riverpoint Medical, LLC
Orthopedic · 27d
Cleared May 16, 2023
VERSAJET Hydrosurgery System (III)
K220964 · FQH
Smith & Nephew Medical Limited
General & Plastic Surgery · 410d
Cleared May 16, 2023
Evita V800, Evita V600
K222024 · CBK
Draegerwerk AG & CO Kgaa
Anesthesiology · 309d
Cleared May 16, 2023
Babylog VN800, Babylog VN600
K222207 · CBK
Draegerwerk AG & CO Kgaa
Anesthesiology · 295d
Cleared May 16, 2023
Gunther Tulip Vena Cava Filter Retrieval Set
K222254 · MMX
Cook Incorporated
Cardiovascular · 293d
Cleared May 16, 2023
BlueCheck™ Caries Detection & Monitoring
K222560 · LFC
Incisive Technologies Pty, Ltd.
Dental · 265d
Cleared May 16, 2023
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
K222736 · QOF
Hologic, Inc.
Microbiology · 249d
Cleared May 16, 2023
Insufflator
K222812 · HIF
Scivita Medical Technology Co., Ltd.
Obstetrics & Gynecology · 239d
Cleared May 16, 2023
c1Trac
K222912 · ITH
Zimmer Medizinsysteme GmbH
Physical Medicine · 232d
Cleared May 16, 2023
Infrared Heat (Model: E0221)
K223893 · OHS
Light Tree Ventures Europe B.V.
General & Plastic Surgery · 139d
Cleared May 16, 2023
Eminent Spine 3D Lumbar Interbody Fusion Systems
K230219 · MAX
Eminent Spine, LLC
Orthopedic · 110d
Cleared May 16, 2023
BruxZir™ Incisal Coloring Liquid
K230262 · EIH
Prismatik Dentalcraft, Inc.
Dental · 105d
Cleared May 16, 2023
SAVI Dual (TM) Migraine Therapy
K230358 · OKP
Eneura, Inc.
Neurology · 95d
Cleared May 15, 2023
Buzzy® (models: Mini Healthcare, XL Healthcare, Mini Personal, XL Personal, Pro)
K202993 · PHW
Mmj Labs, LLC
Physical Medicine · 957d
Cleared May 15, 2023
HD+12, HD+15
K220526 · DRG
Cardioline S.P.A
Cardiovascular · 445d
Cleared May 15, 2023
Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs
K222836 · NHA
Institut Straumann AG
Dental · 237d
Cleared May 15, 2023
Vathin® Video Bronchoscope System
K223836 · EOQ
Hunan Vathin Medical Instrument Co.,...
Ear, Nose, Throat · 144d
Cleared May 15, 2023
Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs...
K230121 · LZA
Careglove Global Sdn. Bhd.
General Hospital · 118d