FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
127297–127320 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 19, 1990
ADAM (ACOUSTICAL DEVICE FOR ANATOMICAL MONITORING)
K893557 · DQD
Medical Monitors, Inc.
Cardiovascular · 315d
Cleared Mar 19, 1990
LIPIDIRECT LOW DENSITY LIPOPROTEIN CHOLESTEROL TES
K893740 · MRR
Reference Diagnostics, Inc.
Chemistry · 306d
Cleared Mar 19, 1990
KINAMED CERAMIC ATH TOTAL HIP - 28MM BALL
K894904 · LZO
Kinamed, Inc.
Orthopedic · 230d
Cleared Mar 19, 1990
BIOLOG
K895534 · DRT
Micromedical
Cardiovascular · 187d
Cleared Mar 19, 1990
PACEVIEW
K895535 · KRE
Micromedical
Cardiovascular · 187d
Cleared Mar 19, 1990
HTS 820 CARDIAC MONITOR
K896967 · DSI
Life Sensing Instrument Company, Inc.
Cardiovascular · 91d
Cleared Mar 19, 1990
CHEMO-SHIELD
K897105 · FMF
Vision Plastics, Inc.
General Hospital · 88d
Cleared Mar 19, 1990
SYSTEMATE(TM) TOTAL BILIRUBIN CATALOG NO. 654XX
K897176 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 82d
Cleared Mar 19, 1990
OPUS T4 TEST SYSTEM
K897193 · KLI
Pb Diagnostic Systems, Inc.
Toxicology · 80d
Cleared Mar 19, 1990
ADVANCE PRESSURE MONITOR LINE, HIGH PRES., ADMINI.
K897197 · DTL
Advance Medical Designs, Inc.
Cardiovascular · 80d
Cleared Mar 19, 1990
FLEXIGUIDE(TM) CO2 LASER HOLLOW FLEXIBLE FIBER
K900066 · GEX
Luxar Corp.
General & Plastic Surgery · 74d
Cleared Mar 19, 1990
HEMORRHOIDAL LIGATOR WITH SUCTION
K900086 · KDH
Baxter Healthcare Corp
Gastroenterology & Urology · 74d
Cleared Mar 19, 1990
SHARPLAN ND:YAG DISPOSABLE FIBER DELIVERY SYSTEM
K900153 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 67d
Cleared Mar 19, 1990
SKYTRON UNIVERSE SERIES SURGICAL LIGHTS
K900211 · FSY
Skytron, Div. the Kmw Group, Inc.
General & Plastic Surgery · 61d
Cleared Mar 19, 1990
MRT 50A SOFTWARE RELEASE 9.0
K900283 · LNH
Toshiba America Mri, Inc.
Radiology · 56d
Cleared Mar 19, 1990
HYCULT DIAMOND CORONARY BYPASS KNIFE
K900379 · DWS
St. Jude Medical, Inc.
Cardiovascular · 52d
Cleared Mar 19, 1990
WATER JEL STERILE GEL-SOAKED BURN DRESSING
K900516 · FRO
Trilling Medical Technologies, Inc.
General & Plastic Surgery · 45d
Cleared Mar 19, 1990
CLASSIC ECG/STIMULATING NO. 1700 SERIES
K900519 · DRX
Classic Medical Products, Inc.
Cardiovascular · 45d
Cleared Mar 19, 1990
SWIVEL ADAPTER
K900642 · HHI
Williams Specialty Products, Inc.
Obstetrics & Gynecology · 38d
Cleared Mar 19, 1990
IRON LIQUID STABLE REAGENT
K900902 · JIY
Medical Analysis Systems, Inc.
Chemistry · 20d
Cleared Mar 19, 1990
ANTI-RNP MICROASSAY
K901073 · LLL
Diamedix Corp.
Immunology · 11d
Cleared Mar 16, 1990
STAT-TRACH(TM) VENTILATION CATHETER
K894096 · BTO
Statron Corp.
Anesthesiology · 280d
Cleared Mar 16, 1990
MODIFIED STAR CALC
K895963 · BZC
Infrasonics Corp.
Anesthesiology · 156d
Cleared Mar 16, 1990
OLYMPUS HYSTERORESECTOSCOPE
K897003 · HIH
Olympus Corp.
Obstetrics & Gynecology · 88d