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
67345–67368 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 02, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN-TAZOBACTAM 0.5/4-128/4...
K042932 · LON
Becton, Dickinson & CO
Microbiology · 41d
Cleared Dec 02, 2004
DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS
K042941 · GIZ
Dade Behring, Inc.
Hematology · 38d
Cleared Dec 02, 2004
MONARCH, TRANSSHAPING GASTROSTOMY TUBE, MODEL 9-XX20
K043027 · KNT
Applied Medical Technology, Inc.
Gastroenterology & Urology · 29d
Cleared Dec 01, 2004
MEDTRADE PRODUCTS ANTISEPTIC BARRIER SILVER FOAM DRESSING, MODEL 09912450
K033732 · FRO
Medtrade Products , Ltd.
General & Plastic Surgery · 369d
Cleared Dec 01, 2004
DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE
K040888 · GXQ
Collagen Matrix, Inc.
Neurology · 240d
Cleared Dec 01, 2004
ULTRADENT CARBON MASK - UPI #342
K041047 · FXX
Medspring Group, Incorporated
General Hospital · 223d
Cleared Dec 01, 2004
SMARTWAVE MS 2000
K041063 · IPF
Newwave Medical, LLC
Physical Medicine · 222d
Cleared Dec 01, 2004
POWDERFREE COLORED AND FLAVORED CHLOREPRENE PATIENT EXAMINATION GLOVES TESTED...
K041913 · LZA
Pt. Medisafe Technologies
General Hospital · 139d
Cleared Dec 01, 2004
EVLT KIT AND THE D15PLUS AND D30PLUS DIODE LASERS
K041957 · GEX
Diomed, Inc.
General & Plastic Surgery · 133d
Cleared Dec 01, 2004
UNISILK
K042282 · GAP
United Medical Industries Co. , Ltd.
General & Plastic Surgery · 99d
Cleared Dec 01, 2004
UNIPRO
K042283 · GAW
United Medical Industries Co. , Ltd.
General & Plastic Surgery · 99d
Cleared Dec 01, 2004
UNIESTER C
K042286 · GAT
United Medical Industries Co. , Ltd.
General & Plastic Surgery · 99d
Cleared Dec 01, 2004
CONTROL PLASMA N, PROC CONTROL PLASMA
K042333 · GGN
Dade Behring, Inc.
Hematology · 93d
Cleared Dec 01, 2004
OUTPATIENT III MINOR SURGERY LIGHT
K042395 · FSY
Burton Medical Products Corp.
General & Plastic Surgery · 90d
Cleared Dec 01, 2004
VITROS CHEMISTRY PRODUCTS VALP REAGENT
K042476 · LEG
Ortho-Clinical Diagnostics, Inc.
Chemistry · 79d
Cleared Dec 01, 2004
GAMMA-B 1,25-DIHYDROXY VITAMIN D
K042519 · MRG
Immunodiagnostic Systems , Ltd.
Chemistry · 76d
Cleared Dec 01, 2004
DRAGON HEART PISTON SYRINGE
K042547 · FMF
Dragon Heart Medical Devices Co., Ltd.
General Hospital · 72d
Cleared Dec 01, 2004
HARMONIC ACE CURVED SHEARS WITH HAND CONTROL, MODEL ACE23P, ACE36P
K042777 · LFL
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 56d
Cleared Dec 01, 2004
COSMEDENT PIT & FISSURE SEALANT
K042823 · EBC
Cosmedent, Inc.
Dental · 50d
Cleared Dec 01, 2004
OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700
K042828 · EKR
Young O/S, LLC
Dental · 50d
Cleared Dec 01, 2004
MODIFICATION TO D-TRONPLUS
K043000 · LZG
Disetronic Medical Systems AG
General Hospital · 30d
Cleared Dec 01, 2004
MX POLYAXIAL PEDICLE SCREW
K043001 · MNH
Scient'X
Orthopedic · 30d
Cleared Dec 01, 2004
VASCULAR SOLUTIONS SCLERO-KIT
K043019 · FMI
Vascular Solutions, Inc.
General Hospital · 28d
Cleared Dec 01, 2004
LAPAROSCOPIC COMPRESSION ANASTOMOSIS CLIP (LAPCAC)
K043115 · FZP
Niti Medical Technologies , Ltd.
General & Plastic Surgery · 21d