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
167497–167520 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 17, 1980
CRYPTOCOCCUS NEOFORMANS, ANTIGEN,
K792691 · JWK
Meridian Diagnostics, Inc.
Microbiology · 21d
Cleared Jan 17, 1980
ASPERGILLUS SP, ANTISERUM, POSITIVE
K792698 · KFG
Meridian Diagnostics, Inc.
Microbiology · 21d
Cleared Jan 17, 1980
ASPERGILLUS SP, COMPLEMENT FIXATION
K792700 · JWT
Meridian Diagnostics, Inc.
Microbiology · 21d
Cleared Jan 17, 1980
HISTOPLASMA CAPSULATUM, ANTIGEN YEAST
K792704 · GMJ
Meridian Diagnostics, Inc.
Microbiology · 21d
Cleared Jan 17, 1980
HISTOPLASMA CAPSULATUM, MYCELIAL PHASE
K792708 · GMJ
Meridian Diagnostics, Inc.
Microbiology · 21d
Cleared Jan 17, 1980
HISTOPLASMA CAPSULATUM, ANTISERUM
K792711 · GMJ
Meridian Diagnostics, Inc.
Microbiology · 21d
Cleared Jan 17, 1980
PARA-PAK (C&S)
K792712 · JSM
Meridian Diagnostics, Inc.
Microbiology · 21d
Cleared Jan 17, 1980
COCCIDIOIDES IMMITIS, ANTISERUM POS.
K792717 · GMH
Meridian Diagnostics, Inc.
Microbiology · 21d
Cleared Jan 17, 1980
HISTOPLASMA CAPSULATUM, ANTISERUM
K792718 · GMK
Meridian Diagnostics, Inc.
Microbiology · 21d
Cleared Jan 17, 1980
DOW CORNING/W RIGHT WOUND DRAINAGE SYS
K800014 · GCY
Dow Corning Corp. Healthcare...
General & Plastic Surgery · 13d
Cleared Jan 17, 1980
NON ADHERANT WOUND BANDAGES
K800020 · EFQ
American Medical Disposable, Inc.
General & Plastic Surgery · 13d
Cleared Jan 17, 1980
NON ADHERANT NEUROLOGICAL SPONGES
K800021 · EFQ
American Medical Disposable, Inc.
General & Plastic Surgery · 13d
Cleared Jan 16, 1980
SURGIFEED
K791714 · KNT
Health Development Corp.
Gastroenterology & Urology · 139d
Cleared Jan 16, 1980
MULTIPLE AUTO ANTIBODY TEST
K791996 · DBL
Meda Stat Diagnostics, Inc.
Immunology · 105d
Cleared Jan 16, 1980
CSF-CARDIAC/PERITONEAL CATHETER
K792005 · JXG
Pudenz-Schulte Medical Research Corp.
Neurology · 103d
Cleared Jan 16, 1980
CSF-VENTRICULAR CATHETER, STANDARD DES
K792007 · JXG
Pudenz-Schulte Medical Research Corp.
Neurology · 103d
Cleared Jan 16, 1980
YSI SERIES 500 THERMISTOR PROBES
K792116 · FLL
Yellow Springs Instrument Co., Inc.
General Hospital · 83d
Cleared Jan 16, 1980
TANDEM ASSEMBLED 3&4 WAY STOPCOCKS
K792124 · FMG
Tronomed, Inc.
General Hospital · 84d
Cleared Jan 16, 1980
3&4 WAY PLASTIC STOPCOCKS, NONSTERILE
K792125 · FMG
Tronomed, Inc.
General Hospital · 84d
Cleared Jan 16, 1980
3&4 WAY PLASTIC STERILE STPCKS. PKG.
K792126 · FMG
Tronomed, Inc.
General Hospital · 84d
Cleared Jan 16, 1980
PLAS. STCK. W/EXTENSION TUBE/STERILE
K792127 · FMG
Tronomed, Inc.
General Hospital · 84d
Cleared Jan 16, 1980
STERILE EXTENSION TUBES INDIV. PKG.
K792128 · FMG
Tronomed, Inc.
General Hospital · 84d
Cleared Jan 16, 1980
HYPO-ALLERGENIC PLASTIC TAPE
K792136 · FPX
National Patent Development Corp.
General & Plastic Surgery · 86d
Cleared Jan 16, 1980
SORB SYSTEM URS
K792137 · FKT
Organon Teknika Corp.
Gastroenterology & Urology · 86d