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
168121–168144 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 13, 1980
AMES RIALYZE - UPTAKE CHROM. TUBES
K800170 · KHQ
Miles Laboratories, Inc.
Chemistry · 19d
Cleared Feb 13, 1980
GAMBRO LUNDIA COIL DIALYZER
K800174 · FHS
Gambro, Inc.
Gastroenterology & Urology · 19d
Cleared Feb 13, 1980
EMC-M-175, THYROXINE - 100 TUBES
K800187 · CDX
Endocrine-Metabolic Center
Chemistry · 15d
Cleared Feb 13, 1980
EMC-M-180, T3 UPTAKE - 100 TUBES
K800188 · KHQ
Endocrine-Metabolic Center
Chemistry · 15d
Cleared Feb 13, 1980
BOVINE ALBUMIN 22% & 30% SOLUTIONS
K800189 · KSG
Gotham Biologics, Inc.
Chemistry · 15d
Cleared Feb 13, 1980
STANBIO DIRECT URIC ACID TEST SET #0770
K800190 · CDH
Stanbio Laboratory
Chemistry · 15d
Cleared Feb 13, 1980
CULTURIA MACCONKEY/CLED #DM87
K800215 · JXA
Clinical Convenience Products, Inc.
Microbiology · 9d
Cleared Feb 13, 1980
SEROCLUSTER U AND V
K800240 · JTC
Corning Costar Corp.
Microbiology · 8d
Cleared Feb 11, 1980
AMP DIRECT VASCULAR MONITORING SYSTEM
K792646 · KRH
American Medical Products, Inc.
Cardiovascular · 52d
Cleared Feb 11, 1980
COROMETRICS-PUSH BUTTON SPIRAL ELECTRODE
K792669 · HGP
Ge Medical Systems Information...
Obstetrics & Gynecology · 46d
Cleared Feb 11, 1980
MODEL 807 SUCTION CAUTERY FINGER TIP
K800022 · GEI
Malibu Laboratories
General & Plastic Surgery · 35d
Cleared Feb 11, 1980
MICRO ELISA MINI READER
K800057 · JJQ
Dynatech Laboratories, Inc.
Chemistry · 32d
Cleared Feb 11, 1980
PIPET CALIBRATION KIT
K800062 · JIS
Streck Laboratories, Inc.
Chemistry · 31d
Cleared Feb 11, 1980
COMBISON 100-MODEL 100 & 110
K800091 · IYO
Kt Medical, Inc.
Radiology · 28d
Cleared Feb 11, 1980
TRANSDUCER
K800093
Kt Medical, Inc.
Cardiovascular · 28d
Cleared Feb 11, 1980
COMBISON 200 & COMBISON 202
K800094 · IYO
Kt Medical, Inc.
Radiology · 28d
Cleared Feb 11, 1980
MGD-3
K800095 · KNG
Kt Medical, Inc.
Obstetrics & Gynecology · 28d
Cleared Feb 11, 1980
AMBIVASON DR-200
K800096 · JAF
Kt Medical, Inc.
Radiology · 28d
Cleared Feb 11, 1980
MINIVASON 9
K800097 · JAF
Kt Medical, Inc.
Radiology · 28d
Cleared Feb 11, 1980
MINIFETON 200
K800098 · KNG
Kt Medical, Inc.
Obstetrics & Gynecology · 28d
Cleared Feb 11, 1980
TELESONIC (HEARING AID)
K800105 · ESD
Telesonic, Inc.
Ear, Nose, Throat · 26d
Cleared Feb 11, 1980
SEARS BEHIND-THE-EAR HEARING AID
K800113 · ESD
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 26d
Cleared Feb 11, 1980
TRU-PULSE PADS
K800117 · GXY
Ipco Corp.
Neurology · 24d
Cleared Feb 11, 1980
CENTRIFICHEM ALP/ALKALINE PHOSPHATASE
K800131 · CJE
Union Carbide Corp.
Chemistry · 24d