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
69577–69600 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 05, 2004
REAADS VON WILLEBRAND FACTOR ACTIVITY TEST KIT, MODEL 10826
K032139 · GGP
Corgenix, Inc.
Hematology · 269d
Cleared Apr 05, 2004
CUSTODIOL
K032794 · MSB
Dr. Franz Kohler Chemie GmbH
Gastroenterology & Urology · 210d
Cleared Apr 05, 2004
DELIGHT DENTAL ER: YAG LASER SYSTEM
K032797 · GEX
Hoya Photonics, Inc.
General & Plastic Surgery · 210d
Cleared Apr 05, 2004
EASY COMFORT DELUXE MANUAL BREAST PUMP, MODEL 1187
K032845 · HGY
The First Years, Inc.
Obstetrics & Gynecology · 207d
Cleared Apr 05, 2004
LOVELY SYSTEM
K033946 · FTC
Msq (M2) , Ltd.
General & Plastic Surgery · 108d
Cleared Apr 05, 2004
DYNATRAC, COD. 50-1A
K034051 · IYE
3D Line USA, Inc.
Radiology · 97d
Cleared Apr 05, 2004
SAFETYNET GUIDEWIRE INTRODUCER
K040029 · DYB
Injectimed, Inc.
Cardiovascular · 88d
Cleared Apr 05, 2004
ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MPO/PR3 IGG TEST SYSTEM
K040111 · MOB
Zeus Scientific, Inc.
Immunology · 76d
Cleared Apr 05, 2004
K-Y BRAND WARMING JELLY PERSONAL LUBRICANT
K040164 · NUC
Personal Products Company, Div. of...
Obstetrics & Gynecology · 70d
Cleared Apr 05, 2004
PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM
K040772 · ILJ
Penner Manufacturing, Inc.
Physical Medicine · 10d
Cleared Apr 02, 2004
OSTEOSET DBM PELLETS, MODEL 8600-48XX
K022828 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 585d
Cleared Apr 02, 2004
THE CARDIOP-B SYSTEM
K030139 · IZI
Paieon, Inc.
Radiology · 444d
Cleared Apr 02, 2004
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN...
K031601 · LON
Dade Behring, Inc.
Microbiology · 317d
Cleared Apr 02, 2004
BIRDSONG LEVERHALER, MODEL LH-1000
K031982 · CAF
Birdsong Medical Devices, Inc.
Anesthesiology · 281d
Cleared Apr 02, 2004
CHRONO-LOG WHOLE BLOOD AGGREGOMETER, MODELS 591A AND 592A
K032951 · JOZ
Chrono-Log Corp.
Hematology · 193d
Cleared Apr 02, 2004
GENZYME OSOM TRICHOMONAS RAPID TEST
K033864 · JWZ
Genzyme Corp.
Microbiology · 112d
Cleared Apr 02, 2004
ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
K033875 · DQY
Cook, Inc.
Cardiovascular · 109d
Cleared Apr 02, 2004
MSI MODEL S-500 RF GENERATOR
K033888 · GEI
Medsphere International, Inc.
General & Plastic Surgery · 108d
Cleared Apr 02, 2004
WELL@HOME SYSTEM
K040012 · DXN
Zoe Medical, Inc.
Cardiovascular · 88d
Cleared Apr 02, 2004
EAGLE ANTERIOR CERVIAL PLATE SYSTEM
K040197 · KWQ
Depuyacromed
Orthopedic · 64d
Cleared Apr 02, 2004
LASERPRO CO2 CARBON DIOXIDE LASER SYSTEM
K040234 · GEX
Photo Medex, Inc.
General & Plastic Surgery · 60d
Cleared Apr 02, 2004
CALIBRATOR FOR AUTOMATED SYSTEMS PROTEINS IN URINE/CSF
K040264 · JIX
Roche Diagnostics Corp.
Chemistry · 58d
Cleared Apr 02, 2004
NOVA-ONE LIPID CONTROL (SPECIAL LOW INTERFERENCE LIQUID LIPID CONTROL)
K040352 · JJY
Bioresource Technology, Inc.
Toxicology · 50d
Cleared Apr 02, 2004
IDEAL 1 ORTHODONTIC BAND CEMENT
K040375 · DYH
Dentsply Intl.
Dental · 45d