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

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176,076 results
152233–152256 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 28, 1984
TISSUE-TEK IMMUNOHISTOLOGY KIT LYSOZZM
K842470 · DFH
Miles Laboratories, Inc.
Immunology · 64d
Cleared Aug 28, 1984
AMIZYME-LEISHMANIA SPP. TEST KIT
K842526 · LOO
Amico Lab, Inc.
Immunology · 61d
Cleared Aug 28, 1984
ANTI-TOXOPLASMA GONDII KIT
K842664 · GLZ
Amico Lab, Inc.
Immunology · 49d
Cleared Aug 28, 1984
FIAX TOTAL IGE TEST KIT
K842749 · DGP
Intl. Diagnostic Technology
Immunology · 46d
Cleared Aug 28, 1984
PMK PRIMARY MONKEY KIDNEY-CELLS
K842833 · KJR
Bartels Immunodiagnostic Supplies, Inc.
Immunology · 39d
Cleared Aug 28, 1984
HEP-2 CELLS
K842834 · KJR
Bartels Immunodiagnostic Supplies, Inc.
Immunology · 39d
Cleared Aug 28, 1984
CB FORMALIN
K842862 · IGE
Anatech, Ltd.
Pathology · 36d
Cleared Aug 28, 1984
CBA FORMALIN
K842940 · IFP
Anatech, Ltd.
Pathology · 34d
Cleared Aug 28, 1984
ALLERGENETICS ALLER-SPECIFIC IGE SERUM
K842969 · DGP
Allergenetics
Chemistry · 29d
Cleared Aug 28, 1984
RPMI-1640 MEDIUM #R3505 W/HAT, L-GLUTA
K843085 · KIT
Sigma Chemical Co.
Microbiology · 22d
Cleared Aug 28, 1984
DULBECCO'S MODIFIED EAGLE'S NUTIRENT MIX
K843086 · KIT
Sigma Chemical Co.
Microbiology · 22d
Cleared Aug 27, 1984
FOGARTY OCCLUDER PAD
K831809 · DXC
Thomas J. Fogarty, M.D.
Cardiovascular · 448d
Cleared Aug 27, 1984
ANGIOGRAPHIC PROCEDURE TRAY
K840391 · DQX
Triad Medical Division
Cardiovascular · 210d
Cleared Aug 27, 1984
STROVER HOOK
K841617 · HCF
Plastafil, Inc.
General & Plastic Surgery · 130d
Cleared Aug 27, 1984
THREADING TUBE
K841618 · FZX
Plastafil, Inc.
General & Plastic Surgery · 130d
Cleared Aug 27, 1984
PROBE
K841624 · HRX
Plastafil, Inc.
Orthopedic · 130d
Cleared Aug 27, 1984
HOOK
K841625 · GAD
Plastafil, Inc.
General & Plastic Surgery · 130d
Cleared Aug 27, 1984
PUNCH
K841626 · HXG
Plastafil, Inc.
Orthopedic · 130d
Cleared Aug 27, 1984
MALLET
K841627 · HWA
Plastafil, Inc.
Orthopedic · 130d
Cleared Aug 27, 1984
DRILL BIT
K841629 · HTW
Plastafil, Inc.
Orthopedic · 130d
Cleared Aug 27, 1984
THE DENVER PLEURAL-PERITONEAL SHUNT
K842139 · KPM
Denver Biomedicals, Inc.
Gastroenterology & Urology · 89d
Cleared Aug 27, 1984
PRESSURE MONITOR
K842194 · DXS
Norton Texas Medical Products
Cardiovascular · 84d
Cleared Aug 27, 1984
SERVOCARD DEFIBRILLATOR SCP-851
K842235 · LDD
Litton Datamedix
Cardiovascular · 83d
Cleared Aug 27, 1984
FLUID WARMER
K842302 · FLA
Organon Teknika Corp.
Gastroenterology & Urology · 77d