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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
148441–148464 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 21, 1985
SYNCORTECH CHLAMYDIA DIRECT SPECIMAN KIT
K851033 · LJP
Syncor Intl. Corp.
Microbiology · 101d
Cleared Jun 21, 1985
PENOX LIFT CHAIR
K851218 · INO
Penox Technologies, Inc.
Physical Medicine · 87d
Cleared Jun 21, 1985
GIBCO MYCOTECT 189-5670
K851275 · KIW
Gibco Laboratories Life Technologies,...
Microbiology · 81d
Cleared Jun 21, 1985
VIRTRAN VIRAL TRANPORTER
K851378 · LIO
Diagnon Corp.
Microbiology · 74d
Cleared Jun 21, 1985
VENTREZYME ALLERGEN DATA REDUCTION SYSTEM
K851403 · JQW
Ventrex Laboratories, Inc.
Immunology · 73d
Cleared Jun 21, 1985
MULTICOR S, MODELS 330A/331A
K851420 · DXY
Cordis Corp.
Cardiovascular · 73d
Cleared Jun 21, 1985
TIMENTIN 85 MCG. SENSI-DISC
K851622 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 64d
Cleared Jun 21, 1985
MANAN MENGHINI NEEDLE
K851836 · KNW
Manan Manufacturing Co., Inc.
Gastroenterology & Urology · 54d
Cleared Jun 21, 1985
MANAN CHIBA PTC NEEDLE
K851838 · KNW
Manan Manufacturing Co., Inc.
Gastroenterology & Urology · 56d
Cleared Jun 21, 1985
MANAN MADAYAG PTC NEEDLE
K851839 · KNW
Manan Manufacturing Co., Inc.
Gastroenterology & Urology · 56d
Cleared Jun 21, 1985
LASER PREALBUMIN TEST
K851912 · JZJ
Behring Diagnostics, Inc.
Immunology · 51d
Cleared Jun 21, 1985
SS-A(RO) & SS-B(LA) ANTIBODY ASSAY
K852033 · DHN
Meloy Laboratories, Inc.
Immunology · 43d
Cleared Jun 21, 1985
PRIVATAN HOME TANNING CENTER
K852290 · FTC
Privatan, Inc.
General & Plastic Surgery · 23d
Cleared Jun 20, 1985
TEMREX-DENTIN VARNISH
K851030 · LBH
Temrex Corp.
Dental · 100d
Cleared Jun 20, 1985
GV MEDICAL, INC. LASTAC BALLOON DILATATION CATHETE
K851080 · LIT
G V Medical, Inc.
Cardiovascular · 94d
Cleared Jun 20, 1985
TRACOR 200 MICROPROCESSOR AUDIOMETER/TRACOR RA 200
K851392 · EWO
Tracor Instruments, Inc.
Ear, Nose, Throat · 72d
Cleared Jun 20, 1985
TEACHER TM
K851655 · LRA
Monargue Intl.
Ear, Nose, Throat · 59d
Cleared Jun 20, 1985
7-103, 7-104, 7-107 SCALPEL HANDLES, #3 #4 #7
K851750 · GDZ
Artiberia
General & Plastic Surgery · 56d
Cleared Jun 20, 1985
7-120, 7-130,7-140, 7-150,9-151 TO 168, 9-171 TO 1
K851751 · GDX
Artiberia
General & Plastic Surgery · 56d
Cleared Jun 20, 1985
9-190,9-200,9-210,9-220 AMPUTATION KNIVES, VARIOUS
K851752 · GDN
Artiberia
General & Plastic Surgery · 56d
Cleared Jun 20, 1985
13-100 TO 13-158 VARIOUS TYPES OF OPERATING SCISSO
K851753
Artiberia
General & Plastic Surgery · 56d
Cleared Jun 20, 1985
13-160 INCISION SCISSORS, TWO SIZES
K851754
Artiberia
General & Plastic Surgery · 56d
Cleared Jun 20, 1985
13-170 DEAVER SCISSOR, TWO SIZES
K851755
Artiberia
General & Plastic Surgery · 56d
Cleared Jun 20, 1985
13-180 TO 13-212 VARIOUS MODELS OF MAYO SCISSORS
K851756
Artiberia
General & Plastic Surgery · 56d