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
152977–153000 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 02, 1984
IDL-LYSING REAGENT
K842069 · GGK
Interscience Diagnostics, Inc.
Hematology · 40d
Cleared Jul 02, 1984
IDD DETERGENT
K842070 · PPM
Interscience Diagnostics, Inc.
Hematology · 40d
Cleared Jul 02, 1984
VENTRESCREEN STREP A TEST
K842239 · GWC
Ventrex Laboratories, Inc.
Microbiology · 27d
Cleared Jul 02, 1984
PATHO DX LATEX AGGLUTINATION STREP A
K842383 · GTZ
Diagnostic Products Corp.
Microbiology · 14d
Cleared Jul 02, 1984
BIOTIS N.Y.C. CARBOHYDRATE FERMENTA-
K842400
Otisville Biotech, Inc.
Microbiology · 13d
Cleared Jul 02, 1984
BIOTIS LD-PRESUMPTO QUADRANT PLATE
K842424 · JSE
Otisville Biotech, Inc.
Microbiology · 12d
Cleared Jul 02, 1984
RIM STREP KIT
K842451 · JSE
Austin Biological Laboratories
Microbiology · 10d
Cleared Jul 02, 1984
PHADEXACT SERUM, ALLERGEN SPECIFIC IGE
K842457 · DHB
Pharmacia, Inc.
Immunology · 10d
Cleared Jun 28, 1984
ARGYLE ENTERNAL FEEDING BAG W/ADMIN
K840877 · HFS
Sherwood Medical Co.
General Hospital · 122d
Cleared Jun 28, 1984
MEDILOG PH1
K840934 · EXW
Oxford Medilog, Inc.
Gastroenterology & Urology · 115d
Cleared Jun 28, 1984
INTRAVASCULAR CATHETER SECUREMENT DEV
K841487 · KMK
Tapemark Co.
General Hospital · 79d
Cleared Jun 28, 1984
VASCULAR-ACCESS-PORT WITHDRAWL-BLOOD
K841679 · LJT
Norfolk Medical Products, Inc.
General Hospital · 66d
Cleared Jun 28, 1984
SKYNDEX ELECTRONIC BODY FAT CALCULA
K841687 · KTZ
Caldwell, Justiss & Co., Inc.
Chemistry · 66d
Cleared Jun 28, 1984
THINWALL PUNCTURE NEEDLE
K841704 · FMI
Meadox Surgimed, Inc.
General Hospital · 66d
Cleared Jun 28, 1984
ENDOPORT EROCAR
K841716 · FBQ
Endotherapeutics
General & Plastic Surgery · 64d
Cleared Jun 28, 1984
CRITIKON I.V. FILTER
K842075 · FPB
Critikon Company, LLC
General Hospital · 36d
Cleared Jun 28, 1984
PIRD-Y
K842262 · ISB
Pirdy, Inc.
Physical Medicine · 21d
Cleared Jun 28, 1984
DIALYSATE ADDITIVES
K842294 · FKQ
Dialysis Products, Inc.
Gastroenterology & Urology · 17d
Cleared Jun 28, 1984
PRESSURE RELIEF SEAT CUSHION
K842380 · KIC
American Pharmaseal Div. Ahsc
Physical Medicine · 10d
Cleared Jun 28, 1984
PARA THERM BATH
K842423 · IMC
Grimm Scientific Industries, Inc.
Physical Medicine · 8d
Cleared Jun 27, 1984
FORMA-FAS-TEST
K833128 · LIF
Chemical Detection & Experimentation
Pathology · 288d
Cleared Jun 27, 1984
VENTRAL WALL DEFECT REDUCT SILO
K840172 · FTL
American Heyer Schulte
General & Plastic Surgery · 162d
Cleared Jun 27, 1984
RESTODENT DENTIN BONDING AGENT
K840726 · KLE
Lee Pharmaceuticals
Dental · 127d
Cleared Jun 27, 1984
DEMLAR SYS I COMPUTER BASED AUDIOMETER
K841167 · EWO
Demlar Medical, Inc.
Ear, Nose, Throat · 100d