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
168889–168912 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 13, 1979
STREP-SPEC
K791991 · JSS
Micro-Media Systems, Inc.
Microbiology · 41d
Cleared Nov 13, 1979
LANCER L-INA HUMAN REFERENCE SERUM
K792013 · JIX
Sherwood Medical Industries
Immunology · 39d
Cleared Nov 13, 1979
LANCER L-INA BUFFER, POLYMER, WASH SOLU
K792014 · JZW
Sherwood Medical Industries
Immunology · 39d
Cleared Nov 13, 1979
SILICONE RUBBER-BI NASOPHARYNGEAL AIR
K792018 · BTQ
Vesta, Inc.
Anesthesiology · 35d
Cleared Nov 13, 1979
WRIGHTS RAPID STAIN
K792026 · IAF
Mcb Manufacturing Chemists, Inc.
Hematology · 35d
Cleared Nov 13, 1979
NON-A-THERM
K792037 · KOD
Labarge, Inc.
Gastroenterology & Urology · 33d
Cleared Nov 13, 1979
NELATON CATHETER
K792038 · KOD
American Hospital Supply Corp.
Gastroenterology & Urology · 32d
Cleared Nov 13, 1979
BARD BIOMEDICAL PRINTED SILVER ELECTRODE
K792040 · DRX
C.R. Bard, Inc.
Cardiovascular · 32d
Cleared Nov 13, 1979
CKG CARDIOKYMOGRAPH
K792051 · DSB
Cardio Kinetics, Inc.
Cardiovascular · 29d
Cleared Nov 13, 1979
SPECTRA CENTRAL PT MONITORING SYS
K792081 · DSI
American Optical Corp.
Cardiovascular · 28d
Cleared Nov 13, 1979
GAVAGE FEEDING SET
K792082 · EYN
Medical Devices, Inc.
General & Plastic Surgery · 28d
Cleared Nov 13, 1979
MICROFLAME PHOTOMETER
K792087 · JJO
Gilford Instrument Laboratories, Inc.
Chemistry · 27d
Cleared Nov 13, 1979
DRYDEN BACTERIA FILTER
K792097 · CAH
Dryden Corp.
General Hospital · 26d
Cleared Nov 13, 1979
GAS-TRAK BLOOD GAS CONTROL
K792098 · JJS
United Diagnostics, Inc.
Chemistry · 25d
Cleared Nov 13, 1979
GRASPING FORCEP (W/FOUR PRONGS)
K792100 · GEN
Eder Instrument Co, Inc.
General & Plastic Surgery · 25d
Cleared Nov 13, 1979
AIR-SHIELDS HEART RATE MONITOR
K792117 · DRT
Narco Air-Shields
Cardiovascular · 18d
Cleared Nov 13, 1979
AIR-SHIELDS RESUSCITATORS
K792118 · BTM
Narco Air-Shields
Anesthesiology · 18d
Cleared Nov 13, 1979
EMIT CLINICAL PROCESSOR-CP 5000
K792129 · JQP
Syva Co.
Toxicology · 20d
Cleared Nov 13, 1979
TRANSVENOUS BALLOON CATH. INTRO. KIT
K792130 · DYB
Stanco Medical, Inc.
Cardiovascular · 18d
Cleared Nov 13, 1979
TEMPORARY TRANSVENOUS PACMKER. ELECTRODE
K792131 · DYB
Stanco Medical, Inc.
Cardiovascular · 18d
Cleared Nov 13, 1979
SMAC (SEQUENTIAL MULT. ANALYSIS COMP.
K792138 · CEK
Fisher Scientific Co., LLC
Chemistry · 22d
Cleared Nov 13, 1979
FEATHER-LITE URINARY DIV. POUCH
K792139 · EXB
Howmedica Corp.
Gastroenterology & Urology · 22d
Cleared Nov 13, 1979
FISHER DIAG. PRIME BLOOD GAS CONTROLS
K792143 · JJS
Fisher Scientific Co., LLC
Chemistry · 20d
Cleared Nov 13, 1979
MTC OXYGEN CONCENTRATOR, OR PRIME-AIRE
K792149 · CAW
Molecular Technologies Corp.
Anesthesiology · 22d