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
173953–173976 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 05, 1977
NEBULIZER
K770664 · CAF
J & S Industries, Inc.
Anesthesiology · 89d
Cleared Jul 05, 1977
REAGENT KIT, ENZYMATIC AMYLASE
K770750 · JFJ
Beckman Instruments, Inc.
Chemistry · 71d
Cleared Jul 05, 1977
IN VITRO DIAG. FOR URIC ACID
K770767 · CDO
Smithkline Diagnostics, Inc.
Chemistry · 68d
Cleared Jul 05, 1977
TUBE, STAIN, RETICULOCYTE, LARC
K770792 · KFC
Corning Medical & Scientific
Hematology · 64d
Cleared Jul 05, 1977
HEMOTOLOGY PRODU&TS (5 IN ALL)
K770803 · GKK
Hycel, Inc.
Chemistry · 64d
Cleared Jul 05, 1977
SPIROMETEO EXHAUST
K770907 · BZK
Timeter Instrument Corp.
Anesthesiology · 48d
Cleared Jul 05, 1977
RECORD, MODEL 702, I.L.
K770946 · DSF
Instrumentation Laboratory CO
Cardiovascular · 43d
Cleared Jul 05, 1977
TA-2 TEMPERATURE ALARM
K770984 · BZE
Mistogen Equipment Co.
Anesthesiology · 35d
Cleared Jul 05, 1977
ELECTROCARDIOGRAPHIC PATIENT CABLES
K771027 · DSA
Tronomed, Inc.
Cardiovascular · 27d
Cleared Jul 05, 1977
ANALYZER, OXYGEN, MODEL OM-92
K771028 · CCL
Cavitron Corp.
Anesthesiology · 26d
Cleared Jul 05, 1977
CULTURE TEST FOR NEISSERIA GONORRHOEAE
K771035 · JTY
Miles Laboratories, Inc.
Microbiology · 25d
Cleared Jul 05, 1977
ANESTHESIA MACHINE
K771057 · BSZ
Foregger
Anesthesiology · 22d
Cleared Jul 05, 1977
ODUFLEX AEROSOL SET
K771061 · CAF
Bd Becton Dickinson Vacutainer...
Anesthesiology · 22d
Cleared Jul 05, 1977
NEBULIZER, MOLEL 503, PART #17068
K771105 · CAF
Hospal Medical Corp.
Anesthesiology · 15d
Cleared Jul 05, 1977
ANESTHESIA BREATHING CIRCUIT
K771134 · CAI
Air Products & Chemicals, Inc.
Anesthesiology · 12d
Cleared Jul 01, 1977
CART, PROCEDURES
K770438 · HDD
I E Industries
Obstetrics & Gynecology · 116d
Cleared Jul 01, 1977
HEMATRAK
K770680 · GKZ
Geometric Data, Div. Smithkline Corp.
Hematology · 81d
Cleared Jul 01, 1977
CPK ULTRAZYME PLUS
K770694 · CGS
Harleco Diagnostics
Chemistry · 77d
Cleared Jul 01, 1977
UNIVUE I
K770954 · IYX
Union Carbide Corp.
Radiology · 37d
Cleared Jul 01, 1977
MOSQUITO
K771013 · CBT
Emde Corp.
Anesthesiology · 25d
Cleared Jul 01, 1977
EPTONE BACK-UP BROTH, VACUTAINER
K771058 · JTW
Bd Becton Dickinson Vacutainer...
Microbiology · 18d
Cleared Jul 01, 1977
TELHTHERAPY SIMULATOR AECL-CP, G-3200
K771096 · JAA
Atomic Energy of Canada
Radiology · 11d
Cleared Jul 01, 1977
FORCEPS, OB, NON-COMPRESSIVE
K771106 · HDA
Zeppelin Medizinlechnik GmbH
Obstetrics & Gynecology · 11d
Cleared Jun 29, 1977
STERILE CONTINER, X-RAY CASSETTE HOLDER
K770903 · IZL
North Shore Orthopaedic Group, S.C.
Radiology · 72d