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
5449–5472 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Oct 23, 2024
Vitesse (5.0)
K241876 · MUJ
Varian Medical Systems
Radiology · 117d
Cleared Oct 23, 2024
Immediate Molar Implants
K241753 · DZE
Biomet 3i, LLC
Dental · 127d
Cleared Oct 23, 2024
LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system
K241324 · SAN
Affinity Biosensors, LLC
Microbiology · 166d
Cleared Oct 23, 2024
IDS-iSYS Free Testosterone
K240865 · CDZ
Immunodiagnostic Systems Limited
Chemistry · 209d
Cleared Oct 23, 2024
Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C,...
K240289 · EOQ
Scivita Medical Technology Co., Ltd.
Ear, Nose, Throat · 265d
Cleared Oct 23, 2024
KIDNEYvault Portable Renal Perfusion System
K234060 · KDN
Paragonix Technologies
Gastroenterology & Urology · 306d
Cleared Oct 22, 2024
nordicMEDiVA
K243209 · LLZ
Nordicneurolab AS
Radiology · 21d
Cleared Oct 22, 2024
PuraStat
K242250 · QAU
3-D Matrix Europe SAS
General & Plastic Surgery · 83d
Cleared Oct 22, 2024
Arm Type Blood Pressure Monitor (BPM82)
K242193 · DXN
Avita Corporation
Cardiovascular · 88d
Cleared Oct 22, 2024
Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without...
K242099 · FMF
Sol-Millennium Medical, Inc.
General Hospital · 96d
Cleared Oct 22, 2024
Reprocessed RD SET Adt Pulse Oximeter Sensor (4000)
K241758 · NLF
Stryker Sustainability Solutions
Anesthesiology · 124d