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
10249–10272 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 26, 2023
Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608,...
K230739 · OHT
Shenzhen Ionka Medical Technology...
General & Plastic Surgery · 70d
Cleared May 26, 2023
WellsForm Tricuspid Annuloplasty Band (WF)
K230679 · KRH
Genesee Biomedical, Inc.
Cardiovascular · 74d
Cleared May 26, 2023
Diode Laser System
K230580 · GEX
Smedtrum Medical Technology Co., Ltd.
General & Plastic Surgery · 85d
Cleared May 26, 2023
Eclipse Treatment Planning System (v18.0)
K230557 · MUJ
Varian Medical Systems, Inc.
Radiology · 87d
Cleared May 26, 2023
FlexBand
K230316 · OWW
International Life Sciences
Orthopedic · 109d
Cleared May 26, 2023
Finesse™ Injectable PTA Balloon Dilatation Catheter
K230263 · LIT
Summa Therapeutics, LLC
Cardiovascular · 115d
Cleared May 26, 2023
CORE 500 Digital Stethoscope
K230111 · DQD
Eko Devices, Inc.
Cardiovascular · 129d
Cleared May 26, 2023
VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System,...
K230065 · PNZ
Fiagon GmbH
Ear, Nose, Throat · 137d
Cleared May 26, 2023
Pre-Sure
K230044 · LLZ
Lazarus 3D
Radiology · 140d
Cleared May 26, 2023
Cerebral Adaptive Index (CAI) Algorithm
K223651 · MUD
Edwards Lifesciences, LLC
Neurology · 171d
Cleared May 26, 2023
Niti-S Biliary Speed D Stent
K223626 · FGE
Taewoong Medical Co., Ltd.
Gastroenterology & Urology · 172d
Cleared May 26, 2023
Electric Breast Pump (model: YY-A46, YY-A203, YY-A204, YY-TC201)
K223329 · HGX
Guangzhou Yongyi Industrial Co., Ltd.
Obstetrics & Gynecology · 207d
Cleared May 26, 2023
Dark Star Deformity Pedicle Screw System
K223096 · NKB
Republic Spine, LLC
Orthopedic · 238d
Cleared May 26, 2023
Sweden & Martina Surgical Trays
K222640 · KCT
Sweden & Martina S.P.A.
General Hospital · 267d
Cleared May 26, 2023
V-HYADASE
K222606 · MQL
Vitromed GmbH
Obstetrics & Gynecology · 270d
Cleared May 26, 2023
Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs
K213289 · KGO
Ansell Healthcare Products, LLC
General Hospital · 602d
Cleared May 26, 2023
Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent...
K203599 · KTL
Immuno Concepts, N.A. , Ltd.
Immunology · 898d
Cleared May 25, 2023
S-COMP Reform® POCT Navigation Instruments
K231229 · OLO
Precision Spine, Inc.
Orthopedic · 27d
Cleared May 25, 2023
Stingray LP Catheter
K231176 · DQY
Boston Scientific
Cardiovascular · 30d
Cleared May 25, 2023
STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for...
K231169 · MLR
Plasmapp Co,., Ltd.
General Hospital · 30d
Cleared May 25, 2023
Saranas Early Bird Bleed Monitoring System
K230273 · QFJ
Saranas, Inc.
Cardiovascular · 114d
Cleared May 25, 2023
Soreal Press, Soreal CAD
K230259 · EIH
Shenzhen Up3D Technology Co., Ltd.
Dental · 114d
Cleared May 25, 2023
BB 8 Sinus Dilation Kit
K230258 · LRC
Excelent, Inc.
Ear, Nose, Throat · 114d
Cleared May 25, 2023
Dentis s-Clean SQ-SL Narrow Implant System
K230246 · NHA
Dentis Co., Ltd.
Dental · 115d