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
151777–151800 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 10, 1984
BIOTIS UREA AGAR
K843767 · JSI
Otisville Biotech, Inc.
Microbiology · 15d
Cleared Oct 10, 1984
BIOTIS KLIGLER IRON AGAR
K843768 · JSE
Otisville Biotech, Inc.
Microbiology · 15d
Cleared Oct 10, 1984
BIOTIS LOWENSTEIN-JENSEN MEDIA
K843769 · JSH
Otisville Biotech, Inc.
Microbiology · 15d
Cleared Oct 10, 1984
BIOTIS LYSINE IRON AGAR
K843770
Otisville Biotech, Inc.
Microbiology · 15d
Cleared Oct 10, 1984
BIOTIS SEVEN H 11 AGAR
K843771 · JSH
Otisville Biotech, Inc.
Microbiology · 15d
Cleared Oct 10, 1984
BIOTIS MARTIN LEWIS AGAR
K843817 · JTY
Otisville Biotech, Inc.
Microbiology · 12d
Cleared Oct 09, 1984
48 HOUR SET CHANGES
K842399 · FPB
Tri-Med, Inc.
General Hospital · 112d
Cleared Oct 09, 1984
I.V. TRANSFER SPIKE
K842678 · FPA
Lyphomed, Inc.
General Hospital · 91d
Cleared Oct 09, 1984
MED. SUPPORT STOCKING-VENOFIT LASTOFLEX
K842708 · DWL
Kundt + Co. AG
General Hospital · 89d
Cleared Oct 09, 1984
MASTER-CHEK BOWIE-DICK TYPE TEST
K843182 · JOJ
Arvey Corp.
General Hospital · 57d
Cleared Oct 05, 1984
CATAREX VITRECUTTER I/A DISPOS. CUT
K840063 · HQC
Calliope Corp.
Ophthalmic · 270d
Cleared Oct 05, 1984
CATAREX/ULTRASONICS KIT
K840181 · HQC
Calliope Corp.
Ophthalmic · 262d
Cleared Oct 05, 1984
CORNEAL LIGHT SHIELD
K840834 · HOY
Gabl, Inc.
Ophthalmic · 224d
Cleared Oct 05, 1984
AMER. SURGICAL CORP. EXTRA PLUS PAK
K841738 · HQE
American Surgical Co., Inc.
Ophthalmic · 161d
Cleared Oct 05, 1984
CANON AUTOREF R-10
K841861 · HKO
Canon USA, Inc.
Ophthalmic · 154d
Cleared Oct 05, 1984
ORTHO* RSV ANTIGEN ELISA TEST SYS
K842047 · LKT
Ortho Diagnostic Systems, Inc.
Microbiology · 137d
Cleared Oct 05, 1984
ULTRAMARK 4 ULTRASOUND SYS
K842376 · IYO
Advanced Technology Laboratories, Inc.
Radiology · 109d
Cleared Oct 05, 1984
SAFE & SOFT PANTY SHIELDS
K842838 · HHD
Ipco Corp.
Obstetrics & Gynecology · 77d
Cleared Oct 05, 1984
MICROSCOPE MITTS SUPPORT TRAY COVER
K842859 · HJO
Chiron Vision Corp.
Ophthalmic · 74d
Cleared Oct 05, 1984
STANDARDS & ACCESSORIES FOR NOVA INSTRU
K842873 · JGS
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 74d
Cleared Oct 05, 1984
NIDEK DIGITAL KERATOMETER
K842892 · HQL
Nidek, Inc.
Ophthalmic · 74d
Cleared Oct 05, 1984
LIQUID CHROMATOGRAPHY COLUMNS
K842909 · DPM
Supelco, Inc.
Toxicology · 72d
Cleared Oct 05, 1984
SANITARY PANTY W/PADS & DESIGNED
K843015 · HHD
Hygienics Industries, Inc.
Obstetrics & Gynecology · 66d
Cleared Oct 05, 1984
CANON 60 FUNDUS CAMERA CF-60U
K843021 · HKI
Canon USA, Inc.
Ophthalmic · 65d