FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
152185–152208 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 25, 1984
VITAMIN B12 57CO/FOLATE 125I -
K840462 · CDD
Corning Medical & Scientific
Chemistry · 144d
Cleared Jun 25, 1984
SRC TOTAL KNEE
K841022
Joint Medical Products Corp.
Orthopedic · 105d
Cleared Jun 25, 1984
PULSE GENERATOR 698, 698B & 698L
K841229 · DXY
Siemens Elema AB
Cardiovascular · 95d
Cleared Jun 25, 1984
PENNSYLVANIA HOSPITAL HIP SYS
K841437 · KWL
Biomet, Inc.
Orthopedic · 80d
Cleared Jun 25, 1984
ORTHO VARICELLA-ZOSTER VIRUS IDENT.
K841526 · GQX
Ortho Diagnostic Systems, Inc.
Microbiology · 74d
Cleared Jun 25, 1984
DOUBLE LUMEN SUBLCAVIAN-FEMORAL
K841530 · KNZ
Medical Components, Inc.
Gastroenterology & Urology · 83d
Cleared Jun 25, 1984
NEOS M
K841636 · DXY
Biotronik Sales, Inc.
Cardiovascular · 67d
Cleared Jun 25, 1984
T3 UPTAKE
K841927 · KHQ
Syncor Intl. Corp.
Chemistry · 46d
Cleared Jun 25, 1984
ENZYMATIC ACETAMINOPHEN ASSAY
K841930 · LKP
Diagnostic Chemicals, Ltd. (Usa)
Toxicology · 46d
Cleared Jun 25, 1984
ESTRADIOL DIRECT RADIOIMMUNOASSAY KIT
K841947 · CHP
Sorin Biomedica, Fiat, USA, Inc.
Chemistry · 42d
Cleared Jun 25, 1984
TESTOSTERONE DIRECT RADIOIMMUNOASSAY
K841948 · CDZ
Sorin Biomedica, Fiat, USA, Inc.
Chemistry · 42d
Cleared Jun 25, 1984
PULSE GENERATOR KALOS-04
K841950 · DXY
Biotronik Sales, Inc.
Cardiovascular · 52d
Cleared Jun 25, 1984
DUPONT ACA MAGNESIUM CALIBRATOR
K841955 · JIS
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 42d
Cleared Jun 25, 1984
GASTRIN RIA
K841963 · CGC
Syncor Intl. Corp.
Chemistry · 42d
Cleared Jun 25, 1984
HL-1, DEFINED SERUM FREE MEDIA
K841993 · KIT
Ventrex Laboratories, Inc.
Microbiology · 41d
Cleared Jun 25, 1984
THYROXINE-BINDING GLOBULIN RADIOUMMU
K842010 · CEE
Nichols Institute Diagnostics
Chemistry · 39d
Cleared Jun 25, 1984
SIGMA PROCEDURE 47-UV
K842013 · CGS
Sigma Chemical Co.
Chemistry · 39d
Cleared Jun 25, 1984
BX-400
K842142 · IPF
Bloomex International, Inc.
Physical Medicine · 26d
Cleared Jun 25, 1984
CROUP TENT FRAME
K842192 · CCQ
Home Run Treadmill Co.
Anesthesiology · 21d
Cleared Jun 25, 1984
AMER. PHARMASEAL NO TOUCH SATIN CATHET
K842198 · BSY
American Pharmaseal Div. Ahsc
Anesthesiology · 21d
Cleared Jun 25, 1984
OXY-VAC
K842205 · BSY
Medi-Tech, Inc.
Anesthesiology · 21d
Cleared Jun 25, 1984
OXIDASE TEST STRIPS-OXIDASESURE
K842298 · JSF
Irvine Diagnostic Services
Microbiology · 14d
Cleared Jun 25, 1984
C.A.P.D. AUTOMATIC HEATER PDH 200
K842305 · FKX
Medionics International , Ltd.
Gastroenterology & Urology · 13d
Cleared Jun 22, 1984
TORAY INDUSTRIES FILTRYZER HOLLOW FIBER
K831173 · KOC
Erika, Inc.
Gastroenterology & Urology · 438d