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
71809–71832 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 17, 2003
GC OIA
K023947 · LIR
Thermo Biostar, Inc.
Microbiology · 141d
Cleared Apr 17, 2003
2 BASIC
K030175 · IYE
Capintec, Inc.
Radiology · 90d
Cleared Apr 17, 2003
LIFESTYLES, CONTEMPO OR PRIVATE LABEL-MALE LATEX CONDOM WITH DESENSITIZING...
K030176 · HIS
Suretex, Ltd.
Obstetrics & Gynecology · 90d
Cleared Apr 17, 2003
INTERNATIONAL BIOPHYSICS CORPORATION (IBC) LASER PEEL SYSTEM
K030181 · GEX
International Biophysics Corp.
General & Plastic Surgery · 90d
Cleared Apr 17, 2003
COULTER ACT 5DIFF AUTOLOADER (AL)
K030291 · GKZ
Beckman Coulter, Inc.
Hematology · 79d
Cleared Apr 17, 2003
ARTHROSCOPY PUMP, MODEL A107
K030402 · HRX
W.O.M. World of Medicine AG
Orthopedic · 70d
Cleared Apr 17, 2003
OPHTEC ENCLAVATION NEEDLE
K030471 · HNQ
Ophtec, USA
Ophthalmic · 64d
Cleared Apr 17, 2003
HL888HM
K030499 · DXN
Health & Life Co., Ltd.
Cardiovascular · 57d
Cleared Apr 17, 2003
RIVA-SELF CURE
K030516 · EMA
Southern Dental Industries, Inc.
Dental · 57d