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
5713–5736 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 25, 2024
Pulse Oximeter (YM101, YM102, YM103, YM104, YM201, YM301, YM202, YM302,...
K240092 · DQA
Shenzhen Yimi Life-Technology Co., Ltd.
Anesthesiology · 287d
Cleared Oct 25, 2024
VistaPano S Ceph 2.0 (VistaPano S Ceph)
K240040 · MUH
VATECH Co., Ltd.
Radiology · 294d
Cleared Oct 24, 2024
Manual Wheelchair (SYIV100-CA9221)
K242560 · IOR
Foshan Shunkangda Medical Tech Co., Ltd.
Physical Medicine · 57d
Cleared Oct 24, 2024
ROCC Console
K242512 · LLZ
Philips Medical Systems Nederland B.V.
Radiology · 62d
Cleared Oct 24, 2024
CEREC Cercon 4D CAD/CAM Blocks
K242462 · EIH
Dentsply Sirona
Dental · 66d
Cleared Oct 24, 2024
ArgenZ MTZ
K242458 · EIH
Argen Corporation
Dental · 66d
Cleared Oct 24, 2024
MagDI System (MAG-01, DS-01)
K242086 · SAH
Gt Metabolic Solutions, Inc.
General & Plastic Surgery · 99d
Cleared Oct 24, 2024
Duet External Drainage and Monitoring System (EDMS)
K242034 · PCB
Medtronic Neurosurgery
Neurology · 105d
Cleared Oct 24, 2024
Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)
K241554 · IYN
Telefield Medical Imaging (Shenzhen)...
Radiology · 146d
Cleared Oct 24, 2024
KeyPrint KeyDenture Base
K241089 · EBI
Keystone Industries
Dental · 188d
Cleared Oct 24, 2024
Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01)
K241007 · DXN
Shenzhen Urion Technology Co., Ltd.
Cardiovascular · 195d
Cleared Oct 24, 2024
Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia)
K240543 · GEX
Medency S.R.L.
General & Plastic Surgery · 240d
Cleared Oct 24, 2024
MUTARS® femoral stem cemented 160 mm and 200 mm
K240391 · LZO
Implantcast GmbH
Orthopedic · 259d
Cleared Oct 23, 2024
TrueFit Bolus
K243057 · MUJ
Adaptiiv Medical Technologies, Inc.
Radiology · 26d
Cleared Oct 23, 2024
MIM – Symphony HDR Fusion
K243012 · LLZ
Mim Software, Inc.
Radiology · 26d
Cleared Oct 23, 2024
CD Horizon™ Spinal System
K243007 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 27d
Cleared Oct 23, 2024
OIC Small / Mini Fragment Plate System
K242995 · HRS
The Orthopaedic Implant Company
Orthopedic · 27d
Cleared Oct 23, 2024
EXSYS DEXi (EXSYS DEXi-D401S-FRM)
K242847 · KPR
DRTECH Corporation
Radiology · 33d
Cleared Oct 23, 2024
BluEX Lumbar Expandable Cage System
K242829 · MAX
L & K Biomed Co., Ltd.
Orthopedic · 34d
Cleared Oct 23, 2024
Scarlet® AL-T
K242589 · MAX
Spineart SA
Orthopedic · 54d
Cleared Oct 23, 2024
FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE,...
K242513 · GCJ
Guangdong Optomedic Technologies, Inc.
General & Plastic Surgery · 61d
Cleared Oct 23, 2024
Fractional CO2 Laser Therapy System (EXFU CO2)
K242183 · GEX
Weifang Mingliang Electronics Co., Ltd.
General & Plastic Surgery · 90d
Cleared Oct 23, 2024
STERiJECT Ophthalmic Needle
K242073 · QYM
Tsk Laboratory International Japan KK
General Hospital · 99d
Cleared Oct 23, 2024
ProSeal™ Closed System Bag Access
K241988 · ONB
Epic Medical Pte. , Ltd.
General Hospital · 107d