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
164449–164472 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 05, 1981
MOUTHPIECE, BREATHING
K810793 · BYP
Dhd Medical Products Div. Diemolding...
Anesthesiology · 43d
Cleared May 05, 1981
RUBAZYME - M
K810835 · GOK
Abbott Laboratories
Immunology · 41d
Cleared May 05, 1981
CYBER 80 HEMODIALYZER
K810837 · FJG
Cyberex Corp.
Gastroenterology & Urology · 40d
Cleared May 05, 1981
DIRECT IMMUNOFLUOR. ANTIBODY TEST KIT
K810856 · GPT
Bartels Immunodiagnostic Supplies, Inc.
Immunology · 36d
Cleared May 05, 1981
ENI ANTIBODY TO EPSTEIN-BARR VIRUS
K810860 · GNP
Electro-Nucleonics Laboratories, Inc.
Microbiology · 36d
Cleared May 05, 1981
TECHNICON AUTOGROUPER 16-C SYSTEM
K810899 · KSZ
Technicon Instruments Corp.
Hematology · 32d
Cleared May 05, 1981
CAMPYLOBACTER MED. (PLATE)
K810961 · JSJ
Granite Diagnostics, Inc.
Toxicology · 26d
Cleared May 05, 1981
ISOSIT C & B MATERIAL
K810969 · EBF
Bauer, Cheng & Associates, Inc.
Dental · 26d
Cleared May 05, 1981
ISOSIT TEETH
K810970 · ELM
Bauer, Cheng & Associates, Inc.
Dental · 26d
Cleared May 05, 1981
THE GNATOMET
K810971 · EJP
Bauer, Cheng & Associates, Inc.
Dental · 26d
Cleared May 05, 1981
THE GNATHOMETER-M
K810972 · KZO
Bauer, Cheng & Associates, Inc.
Dental · 26d
Cleared May 05, 1981
MONTGOMERY SILICONE TRACHEAL T-TUBE
K810978 · BTO
Boston Medical Products, Inc.
Anesthesiology · 25d
Cleared May 05, 1981
EARETTE HEARING AID OTICON #E25F
K810986 · ESD
Oticon Corp.
Ear, Nose, Throat · 19d
Cleared May 05, 1981
EARETTE HEARING AID OTICON #E27F
K810987 · ESD
Oticon Corp.
Ear, Nose, Throat · 22d
Cleared May 05, 1981
REVERSIBLE HYDROCOLLOID IMPRESSION
K811020 · ELW
Kottler Laboratories
Dental · 20d
Cleared May 05, 1981
ROOT CANAL KIT
K811023 · ELC
Dentsply Intl.
Dental · 20d
Cleared May 05, 1981
VOGEL & JOHNSON AGAR
K811039 · JSI
Acumedia Manufacturers, Inc.
Microbiology · 19d
Cleared May 05, 1981
CETRIMEDE AGAR
K811040 · JSI
Acumedia Manufacturers, Inc.
Microbiology · 19d
Cleared May 05, 1981
BRILLIANT GREEN AGAR
K811041 · JSI
Acumedia Manufacturers, Inc.
Microbiology · 19d
Cleared May 05, 1981
XLD AGAR
K811042 · JSI
Acumedia Manufacturers, Inc.
Microbiology · 19d
Cleared May 05, 1981
BISMUTH SULFITE AGAR
K811043 · JSI
Acumedia Manufacturers, Inc.
Microbiology · 19d
Cleared May 05, 1981
TRIPLE SUGAR IRON AGAR
K811044 · JSH
Acumedia Manufacturers, Inc.
Microbiology · 19d
Cleared May 05, 1981
LEVIN EOSIN-METHYLENE BLUE AGAR
K811045 · JSI
Acumedia Manufacturers, Inc.
Microbiology · 19d
Cleared May 05, 1981
STERILITY TEST BROTH
K811046 · JSI
Acumedia Manufacturers, Inc.
Microbiology · 19d