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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
68233–68256 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 02, 2004
RESMED HOSPITAL NASAL MASK
K040566 · BZD
Resmed, Ltd.
Anesthesiology · 29d
Cleared Apr 02, 2004
SOMATOM SENSATION 64 AND SENSATION CARDIAC
K040665 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Apr 02, 2004
MESACUP TEST PR-3
K040711 · MOB
Rhigene, Inc.
Immunology · 15d
Cleared Apr 02, 2004
TRUST
K040718 · CAF
Dhd Healthcare Corp.
Anesthesiology · 14d
Cleared Apr 02, 2004
MODIFICATION TO STERRAD SEALSURE CHEMICAL INDICATOR TAPE
K040742 · JOJ
Advanced Sterilization Products
General Hospital · 10d
Cleared Apr 02, 2004
BRITESMILE MASKING CREAM
K040797 · EIE
Britesmile, Inc.
Dental · 4d
Cleared Apr 01, 2004
X-VIEW
K024186 · MUH
Sometech Corporation
Radiology · 469d
Cleared Apr 01, 2004
NASOGASTRIC BRIDLE SYSTEM WITH MAGNETIC RETRIEVAL
K030784 · KNT
Applied Medical Technology, Inc.
Gastroenterology & Urology · 386d