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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
72313–72336 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 22, 2003
SYNTHES STAINLESS STEEL MODULAR HAND SYSTEM
K030310 · HRS
Synthes (Usa)
Orthopedic · 82d
Cleared Apr 22, 2003
STEELEX ELECTRODE SET
K030556 · LDF
Aesculap, Inc.
Cardiovascular · 60d
Cleared Apr 22, 2003
MODIFICATION TO HIOX
K030943 · CBP
Sensor Medics Corp.
Anesthesiology · 27d
Cleared Apr 21, 2003
NICOLET PIONEER TC8080
K020754 · IYN
Nicolet Biomedical
Radiology · 410d
Cleared Apr 21, 2003
LONG WELL LW-6DXX SERIES BODY FAT ANALYZER
K030203 · MNW
Long Well Electronics Corp.
Gastroenterology & Urology · 90d
Cleared Apr 21, 2003
T-SCIENTIFIC T-PAD
K030334 · QSY
T-Scientific, Inc.
General & Plastic Surgery · 80d
Cleared Apr 21, 2003
COULTER LH 750 BODY FLUIDS APPLICATION
K030606 · GKZ
Beckman Coulter, Inc.
Hematology · 55d
Cleared Apr 21, 2003
IBD-QUIK CHEK
K030704 · DEG
Techlab, Inc.
Immunology · 46d
Cleared Apr 21, 2003
SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
K030782 · FTM
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 41d
Cleared Apr 21, 2003
HANSON MEDICAL CALF IMPLANT
K030808 · MIB
Hanson Medical, Inc.
General & Plastic Surgery · 39d
Cleared Apr 21, 2003
HANSON MEDICAL GLUTEAL IMPLANT
K030809 · MIB
Hanson Medical, Inc.
General & Plastic Surgery · 39d
Cleared Apr 21, 2003
RITA STARBURST SDE ELECTROSURGICAL DEVICE
K030967 · GEI
Rita Medical Systems
General & Plastic Surgery · 26d
Cleared Apr 18, 2003
PADTAC ELECTROPHYSIOLOGY RECORDING CATHETERS, JUNCTION CABLE CONNECTOR & CABLE
K021421 · DRF
Tz Medical, Inc.
Cardiovascular · 350d
Cleared Apr 18, 2003
MINIPHYSIONIZER 2.0 AND ELECTRODES
K022950 · EGJ
Physion, Inc.
Physical Medicine · 225d
Cleared Apr 18, 2003
LEFORTE SYSTEM BONE SCREW
K023365 · HWC
Jeil Medical Corporation
Orthopedic · 193d
Cleared Apr 18, 2003
CORONARY ARTERY PERFUSION CANNULA WITH SELF-INFLATING BALLOON
K030231 · DWF
Sorin Group Italia S.R.L.
Cardiovascular · 86d
Cleared Apr 18, 2003
HP-3 HD ELECTRIC WHEELCHAIR
K030427 · ITI
Imc-Heart Way LLC
Physical Medicine · 67d
Cleared Apr 18, 2003
POLY STAT SERUM/URINE HCG TEST
K030430 · JHI
Alidex, Inc.
Chemistry · 67d
Cleared Apr 18, 2003
MODIFIED VERTE-STACK SPINAL SYSTEM
K030735 · MQP
Medtronic Sofamor Danek
Orthopedic · 39d
Cleared Apr 18, 2003
SYNTHES ANTERIOR CSLP SYSTEM
K030866 · KWQ
Synthes (Usa)
Orthopedic · 30d
Cleared Apr 18, 2003
VECTORSONIC, MODEL VU-270
K030880 · IMG
Metron Medical Australia, Pty, Ltd.
Physical Medicine · 29d
Cleared Apr 18, 2003
MODIFICATION TO STRYKER PAINPUMP2
K030885 · FRN
Stryker Instruments
General Hospital · 28d
Cleared Apr 17, 2003
ENDOSCOPIC PLICATION SYSTEM
K023234 · ODE
Ndo Surgical, Inc.
General & Plastic Surgery · 202d
Cleared Apr 17, 2003
VELOCITY ADVANTAGE
K023939 · HQE
Visioncare Devices, Inc.
Ophthalmic · 142d