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
169057–169080 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 22, 1979
THE DENVER SPLINT
K791681 · EPP
Xomed, Inc.
Ear, Nose, Throat · 55d
Cleared Oct 22, 1979
HYDRADJUST II UROLOGICAL TABLE
K791699 · KQS
Sybron Corp.
Gastroenterology & Urology · 54d
Cleared Oct 22, 1979
VENTILATOR TUBE WITH FILTER
K791773 · CAH
Pharmaseal Div., Baxter Healthcare Corp.
General Hospital · 42d
Cleared Oct 22, 1979
OMNI-STANICOR (THETA) MOD 237A
K791783 · DXY
Cordis Corp.
Cardiovascular · 41d
Cleared Oct 22, 1979
MICRO-RING SYSTEM PRECISION ATTACH.
K791788 · EGG
Howmedica Corp.
Dental · 41d
Cleared Oct 22, 1979
I.V. START SET
K791885 · KGX
Ascep, Inc.
General & Plastic Surgery · 41d
Cleared Oct 22, 1979
IMPLANTABLE PROGRAMMABLE UNIPOLAR CARD
K792052 · DXY
Telectronics, Inc.
Cardiovascular · 7d
Cleared Oct 17, 1979
ANTI-HUMAN SERUM
K791282 · DGQ
Diagnostica, Inc.
Immunology · 99d
Cleared Oct 17, 1979
ANTI-HUMAN GLOBULINS
K791285 · DEW
Diagnostica, Inc.
Immunology · 99d
Cleared Oct 17, 1979
MONOJECT ENDOSSEOUS DENTAL IMPLANT TOOL
K791326 · DZI
Sherwood Medical Co.
Dental · 97d
Cleared Oct 17, 1979
LANCER L-INA ANTI-IGA
K791401 · CZP
Sherwood Medical Co.
Immunology · 79d
Cleared Oct 17, 1979
LANCER L-INA ANTI-IGM
K791402 · DFT
Sherwood Medical Co.
Immunology · 79d
Cleared Oct 17, 1979
LANCER L-INA ANTI-IGG
K791403 · DEW
Sherwood Medical Co.
Immunology · 79d
Cleared Oct 17, 1979
LANCER L-INA ANTI-C3
K791404 · CZW
Sherwood Medical Co.
Immunology · 79d
Cleared Oct 17, 1979
CULTURE AND SENSITIVITY KIT
K791413 · JTZ
Biomedia, Inc.
Microbiology · 79d
Cleared Oct 17, 1979
DTM (DERMATOPHYTE TEST MEDIUM) AGAR
K791414 · JSI
Biomedia, Inc.
Microbiology · 79d
Cleared Oct 17, 1979
HI-M-TEST MORPHINE
K791551 · DLR
Technam, Inc.
Toxicology · 64d
Cleared Oct 17, 1979
FLUOROMATIC TOBRAMYCIN FIA IMMUNOASSAY
K791596 · KLB
Bio-Rad
Toxicology · 63d
Cleared Oct 17, 1979
A-GENT GLYCOSPEC
K791642 · LCP
Abbott Laboratories
Hematology · 55d
Cleared Oct 17, 1979
WRIGHT STAIN PACK
K791658
Bioscientific
Hematology · 57d
Cleared Oct 17, 1979
BE-SURE
K791706 · JHJ
Precision Products Corp.
Chemistry · 61d
Cleared Oct 17, 1979
CENTRIA INSULIN RIA
K791707 · CFP
Ventrex Laboratories, Inc.
Chemistry · 50d
Cleared Oct 17, 1979
IMPROVED GRAM STAIN REAGENTS
K791711 · HYI
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 50d
Cleared Oct 17, 1979
BIO-BAG ENVIRONMENTAL CHAMBER (A & B)
K791724 · JTX
Marion Laboratories, Inc.
Microbiology · 48d