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
2401–2424 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 03, 2025
Revolve Surgical System
K243968 · GCJ
Revolve Surgical, Inc.
General & Plastic Surgery · 284d
Cleared Oct 03, 2025
HESTIA (L200-A)
K242946 · GEX
Senbitec Co., Ltd.
General & Plastic Surgery · 373d
Cleared Oct 02, 2025
Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP123, FC-BP125,...
K252769 · DXN
Shenzhen Finicare Co., Ltd.
Cardiovascular · 30d
Cleared Oct 02, 2025
Cannulated Screw and Kirschner (K wire) System
K252758 · HWC
Orthonovis, Inc.
Orthopedic · 34d
Cleared Oct 02, 2025
EasyTeleMed (2.0.2)
K252440 · DRG
Ingeniars S.R.L.
Cardiovascular · 59d
Cleared Oct 02, 2025
MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL
K252114 · JWY
Liofilchem S. R. L.
Microbiology · 87d
Cleared Oct 02, 2025
CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and...
K252059 · OHA
Artivion, Inc.
Cardiovascular · 93d
Cleared Oct 02, 2025
TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)
K251442 · FJK
Ningbo Tianyi Medical Appliance Co.,...
Gastroenterology & Urology · 146d
Cleared Oct 02, 2025
IPL Hair Removal Device (IPL-001, IPL-002)
K251398 · OHT
Shenzhen Enmind Technology Co., Ltd.
General & Plastic Surgery · 149d
Cleared Oct 02, 2025
Philips IntelliSpace Cardiovascular
K251215 · LLZ
Philips Medical Systems Nederland B.V.
Radiology · 167d
Cleared Oct 02, 2025
G-Bond Universal
K251124 · KLE
GC America, Inc.
Dental · 174d
Cleared Oct 02, 2025
BreatheBand® (Model 1000)
K250860 · BYI
Exemplar Medical, LLC
Anesthesiology · 195d
Cleared Oct 02, 2025
LungQ 4
K250766 · JAK
Thirona BV
Radiology · 203d
Cleared Oct 02, 2025
4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)
K250551 · GCJ
Shenzhen Sophway Technology Co., Ltd.
General & Plastic Surgery · 219d
Cleared Oct 02, 2025
Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1)
K250523 · FKX
Simergent, LLC
Gastroenterology & Urology · 223d
Cleared Oct 02, 2025
GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device
K243152 · HEW
Applied Medical Resources Corp.
Obstetrics & Gynecology · 367d
Cleared Oct 01, 2025
Ice Cooling IPL Hair Removal Device (UI20S BK, UI20S BS, UI20S DB, UI20S GP,...
K252804 · OHT
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 28d
Cleared Oct 01, 2025
Picosecond laser device (BMPS4)
K252447 · GEX
Hebei Newangie Technology Co., Ltd.
General & Plastic Surgery · 58d
Cleared Oct 01, 2025
Light Therapy Decollete Mask (1019135)
K252096 · OHS
Merchsource, LLC
General & Plastic Surgery · 90d
Cleared Oct 01, 2025
E Blator
K251899 · GEI
New Deantronics Taiwan , Ltd.
General & Plastic Surgery · 103d
Cleared Oct 01, 2025
Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)
K251825 · OHS
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 110d
Cleared Oct 01, 2025
Vena MicroAngioscope™ System
K251767 · LYK
Vena Medical Holdings Corp
Cardiovascular · 113d
Cleared Oct 01, 2025
Visby Medical Men's Sexual Health Test
K251501 · QEP
Visby Medical, Inc.
Microbiology · 139d
Cleared Oct 01, 2025
Newclip Patient-matched instrumentation non sterile PSI
K250767 · PBF
Newclip Technics
Orthopedic · 202d