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
175513–175536 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 29, 1976
SIGMA PROCEDURE NO. 745 - EP.REAGENT SY
K760591 · JHX
Sigma Chemical Co.
Chemistry · 52d
Cleared Oct 29, 1976
CLINICAL SPECTROPHOTOMETER
K760672 · JJQ
The Dow Chemical Co.
Chemistry · 39d
Cleared Oct 29, 1976
UNIFORM DROP SIZE PASTEUR TYPE PIPETS
K760719 · GJG
Dade, Baxter Travenol Diagnostics, Inc.
Hematology · 32d
Cleared Oct 29, 1976
YEAST ASSIMILATION AGAR
K760764 · JSG
Bioquest
Microbiology · 25d
Cleared Oct 29, 1976
MICRO-ID
K760790 · JSS
General Diagnostics
Microbiology · 22d
Cleared Oct 29, 1976
T-3 UPTAKE KIT
K760802 · KHQ
Diagnostic Products Corp.
Immunology · 17d
Cleared Oct 29, 1976
PNEUMOTACHOGRAPHY SYSTEM
K760816 · GWB
Aftercal, Inc.
Microbiology · 17d
Cleared Oct 29, 1976
TRACOR MODEL RA 208 COMPLIANCE AUDIOM
K760859 · EWO
Tracor Instruments, Inc.
Ear, Nose, Throat · 11d
Cleared Oct 28, 1976
MONITOR, RESPIRATORY (CPAP)
K760339 · BZQ
Sherwood Medical Industries
Anesthesiology · 90d
Cleared Oct 28, 1976
HEMAFLOUR ZP
K760506 · KHO
Buchler Instruments, Inc.
Chemistry · 66d
Cleared Oct 27, 1976
JAR, COLLECTOR FOR SUCTION SYSTEMS
K760333 · GCX
Harris-Lake, Inc.
General Hospital · 90d
Cleared Oct 27, 1976
TEST, LACTATE DEHYDROGENASE
K760345 · CFJ
Princeton Biomedix
Chemistry · 86d
Cleared Oct 27, 1976
ASSAY FOR GAMMA GLUTAMYLTRANSFERASE
K760346 · JPZ
Princeton Biomedix
Chemistry · 86d
Cleared Oct 27, 1976
REAGENT SYSTEM, SIGMA PROCEDURE NO. 270
K760348 · CCZ
Sigma Chemical Co.
Chemistry · 86d
Cleared Oct 27, 1976
SKIN CLIP SYSTEM, DISPOSABLE (AVLOX ICI)
K760357 · FZG
V. Mueller O.V. Baxter Healthcare Corp.
General & Plastic Surgery · 86d
Cleared Oct 27, 1976
DIALYZER (MODEL 1850)
K760374 · FHS
Erika, Inc.
Gastroenterology & Urology · 83d
Cleared Oct 27, 1976
COIL MACHINE ADAPTER
K760725 · FLC
Gambro, Inc.
Gastroenterology & Urology · 30d
Cleared Oct 27, 1976
CONDUCTIVE ANESTHESIA BREATHING CIRCUIT
K760819 · CAI
Omnicon Medical Corp.
Anesthesiology · 15d
Cleared Oct 27, 1976
SOLO-SPHERE HEATER
K760845 · CAF
Respiratory Therapy
Anesthesiology · 13d
Cleared Oct 22, 1976
LIBERATOR/STROLLER
K760787 · BYJ
Burditt & Calkins-Siemens-Elema
Anesthesiology · 16d
Cleared Oct 21, 1976
CASE, CONTACT LENS, PLASTIC
K760046 · HPX
Tomlin B. Horsley, Jr.
Ophthalmic · 128d
Cleared Oct 21, 1976
FISTULA NEEDLE (#11-265)
K760665 · KOC
Cobe Laboratories, Inc.
Gastroenterology & Urology · 34d
Cleared Oct 21, 1976
INDIRECT FLUORESCENT (IFA-ANA)
K760681 · DHN
Wampole Laboratories
Immunology · 31d
Cleared Oct 21, 1976
SPONGE AND GAUZE FORCEP PART #S-417-9
K760703 · GEN
Acme United Corp.
General & Plastic Surgery · 28d