Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
72937–72960 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 17, 2003
ACCUNATE ONE-STEP,ACCUNATE ONE-STEP CASSETTE, ACCUNATE-CHOICE, ACCUNATE HOME...
K030533 · LCX
Cenogenics Corp.
Chemistry · 62d
Cleared Apr 17, 2003
VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100
K030613 · MHX
Criticare Systems, Inc.
Cardiovascular · 50d
Cleared Apr 17, 2003
ANMP (ACOUSTIC NEURO MODULATION PROTOCOL)
K030791 · KLW
Tinnitech, Ltd.
Ear, Nose, Throat · 36d
Cleared Apr 17, 2003
MODIFICATION TO ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, PEG...
K030855 · KNT
Boston Scientific Corp
Gastroenterology & Urology · 30d
Cleared Apr 17, 2003
BLACKSTONE SPINAL FIXATION SYSTEM RIGID CROSS CONNECTOR
K030862 · MNI
Blackstone Medical, Inc.
Orthopedic · 30d
Cleared Apr 17, 2003
POWDERED VINYL EXAM GLOVES, WHITE
K030927 · LYZ
Copioumed Intl., Inc.
General Hospital · 24d
Cleared Apr 17, 2003
GE LOGIQ 9 MODEL 2375600
K030934 · IYN
Ge Medical Systems, Inc.
Radiology · 23d