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
9961–9984 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 30, 2023
Babyroo TN300
K230278 · FMT
Draeger Medical Systems, Inc.
General Hospital · 118d
Cleared May 30, 2023
Excipio SV Aspiration Catheter and Tubing
K230030 · QEW
Contego Medical, Inc.
Cardiovascular · 145d
Cleared May 30, 2023
KBA3D
K223841 · LLZ
S.M.A.I.O
Radiology · 159d
Cleared May 30, 2023
PrecisionTAVI (v1.1)
K223809 · QQI
Dasi Simulations
Cardiovascular · 161d
Cleared May 30, 2023
Smith & Nephew ACCORD™ Cable System
K223762 · HRS
Smith & Nephew
Orthopedic · 166d
Cleared May 30, 2023
Sonic DL
K223523 · LNH
Ge Medical Systems,Llc (Ge Healthcare)
Radiology · 188d
Cleared May 30, 2023
Quicktome Software Suite
K222359 · LLZ
Omniscient Neurotechnology Pty Ltd (O8t)
Radiology · 299d
Cleared May 30, 2023
Hydrozid Precise
K221897 · GEH
Bibawo Medical A/S
General & Plastic Surgery · 334d
Cleared May 30, 2023
MyPAO Guides
K220706 · PBF
Medacta International S.A.
Orthopedic · 446d
Cleared May 28, 2023
Blue Nitrile Examination Gloves Powder Free
K230601 · LZA
Latrile Gloves Private Limited
General Hospital · 86d
Cleared May 26, 2023
Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS
K231233 · JWH
Conformis, Inc.
Orthopedic · 28d
Cleared May 26, 2023
CD Horizon™ Spinal System
K231184 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 30d
Cleared May 26, 2023
Kodiak Lumbar Spacer System
K230851 · MAX
Met One Technologies, LLC
Orthopedic · 59d
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