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
10537–10560 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 25, 2023
IPL Hair Removal Device, Model(s): FY-B505AL, FY-B505AG, FY-B505BL,...
K230549 · OHT
Shenzhen Xiazhifeng Electronic Co., Ltd.
General & Plastic Surgery · 56d
Cleared Apr 25, 2023
Tigereye ST CTO-Crossing Catheter
K230594 · PDU
Avinger, Inc.
Cardiovascular · 53d
Cleared Apr 25, 2023
Konicaminolta DI-X1
K230906 · LLZ
Konica Minolta, Inc.
Radiology · 25d
Cleared Apr 24, 2023
NEST-C Interbody System
K220261 · ODP
Paonan Biotech Co., Ltd.
Orthopedic · 448d
Cleared Apr 24, 2023
Kisar Stratford SI Screw System
K220274 · OUR
Anjali Investments L.L.C
Orthopedic · 448d
Cleared Apr 24, 2023
The Heart Seat
K222330 · MWI
Casana Care, Inc.
Cardiovascular · 265d
Cleared Apr 24, 2023
SmartGUIDE deflectable hydrophilic guidewire
K222690 · MOF
Artiria Medical SA
Neurology · 230d
Cleared Apr 24, 2023
STR8 Clear Aligner
K223141 · NXC
Str8 Oral Care
Dental · 202d
Cleared Apr 24, 2023
Omnipod GO Insulin Delivery Device
K223372 · LZG
Insulet Corporation
Chemistry · 171d
Cleared Apr 24, 2023
Klockner Abutments
K230103 · NHA
SOADCO, S.L.
Dental · 101d
Cleared Apr 24, 2023
TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US)
K230136 · MWP
Compai Healthcare (Suzhou) Co.,Ltd
Radiology · 96d
Cleared Apr 24, 2023
TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core...
K230140 · MWP
Compai Healthcare (Suzhou) Co.,Ltd
Radiology · 96d
Cleared Apr 24, 2023
RAIN Sheath™ Tibial Pedal Introducer
K230704 · DYB
Cordis US Corp
Cardiovascular · 41d
Cleared Apr 21, 2023
Kyphoplasty Balloon System
K221142 · HRX
OK Medinet Korea Co., Ltd.
Orthopedic · 367d
Cleared Apr 21, 2023
CONNEQT PULSE
K221742 · DXN
Atcor Medical
Cardiovascular · 310d
Cleared Apr 21, 2023
AEON Endoscopic Stapler
K222210 · GDW
Lexington Medical, Inc.
General & Plastic Surgery · 270d
Cleared Apr 21, 2023
Paradigm System
K222291 · OLO
Proprio, Inc.
Orthopedic · 263d
Cleared Apr 21, 2023
dentona flexisplint, optimill memosplint, dentona vivatemp, optimill...
K222604 · MQC
Dentona AG
Dental · 235d
Cleared Apr 21, 2023
Modular Rotating Hinge Knee Systems and Compatible Components
K223069 · KRO
Howmedica Osteonics Corp., Dba...
Orthopedic · 203d
Cleared Apr 21, 2023
Estacore-Pro Automatic Biopsy Needle, Geotek Semiautomatic Biopsy Needle,...
K223300 · KNW
Geotek Medikal Ltd Sti
General & Plastic Surgery · 176d
Cleared Apr 21, 2023
ViewFinder Software Version 1.1
K223501 · QIH
Elaitra, Ltd.
Radiology · 151d
Cleared Apr 21, 2023
HERA W10 Diagnostic Ultrasound System
K230084 · IYN
Samsung Medison Co., Ltd.
Radiology · 100d
Cleared Apr 21, 2023
EzDent Web
K230468 · LLZ
Ewoosoft Co., Ltd.
Radiology · 59d
Cleared Apr 21, 2023
Anatase Spine Surgery Navigation System
K230783 · OLO
Remex Medical Corp.
Orthopedic · 30d