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

Filters: Cleared only ×
176,076 results
168337–168360 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 17, 1980
BLASTOMYCES DERMATITIDIS, ANTISERUM
K792685 · KFH
Meridian Diagnostics, Inc.
Microbiology · 21d
Cleared Jan 17, 1980
ASPERGILLUS SP, ANTISERUM POSITIVE
K792686 · KFG
Meridian Diagnostics, Inc.
Microbiology · 21d
Cleared Jan 17, 1980
ASPERGILLUS SP., ANTIGEN
K792687 · JWI
Meridian Diagnostics, Inc.
Microbiology · 21d
Cleared Jan 17, 1980
COCCIDIOIDES IMMITIS, ANTISERUM
K792688 · GMH
Meridian Diagnostics, Inc.
Microbiology · 21d
Cleared Jan 17, 1980
COCCIDIOIDES IMMITIS, ANTIGEN
K792689 · GMI
Meridian Diagnostics, Inc.
Microbiology · 21d
Cleared Jan 17, 1980
COCCIDIOIDES IMMITIS, LATEX AGGLUTI
K792690 · GMG
Meridian Diagnostics, Inc.
Microbiology · 21d
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