FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
74473–74496 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 11, 2002
CONVOY ADVANCED DELIVERY SHEATH
K022067 · DBY
Boston Scientific
Immunology · 78d
Cleared Sep 11, 2002
VERTIS PNT CONTROL UNIT, MODEL CU 100
K022241 · NHI
Vertis Neuroscience, Inc.
Neurology · 62d
Cleared Sep 11, 2002
ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD
K022331 · GKL
Bayer Diagnostics Corp.
Hematology · 55d
Cleared Sep 11, 2002
AUROPAL SOLDER W-2
K022451 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 47d
Cleared Sep 11, 2002
PORTA OP SOLDER M-1
K022452 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 47d
Cleared Sep 11, 2002
IQ PRODUCTS TRIPLE-COLOR FLOW CYTOMETRY REAGENTS, IQ PRODUCTS...
K022528 · GKZ
Iq Corp.
Hematology · 42d
Cleared Sep 11, 2002
MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE
K022677 · DQA
Alaris Medical Systems, Inc.
Anesthesiology · 30d
Cleared Sep 11, 2002
PORTABLE THERAPEUTIC OXYGEN CONCENTRATION SYSTEM (PTOCS)
K022684 · CAW
Essex Cryogenics of Missouri, Inc.
Anesthesiology · 30d
Cleared Sep 11, 2002
NESS SYSTEM
K022776 · IPF
Ness-Neuromuscular Electrical...
Physical Medicine · 21d
Cleared Sep 11, 2002
MODIFICATION TO DISETRONIC D-TRONPLUS INSULIN INFUSION PUMP
K022831 · LZG
Disetronic Medical Systems AG
General Hospital · 16d
Cleared Sep 11, 2002
MODIFICATION TO BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET
K022875 · JKA
Becton, Dickinson & CO
Chemistry · 12d
Cleared Sep 11, 2002
MODIFICATION TO INFANT LIFE SUPPORT MODULE-20
K022876 · FPL
International Biomedical, Inc.
General Hospital · 12d
Cleared Sep 10, 2002
WIENER LAB. CA-COLOR ARSENAZO III AA, MODEL 4X50 ML CAT.NR. 1152004, WIENER...
K021334 · CJY
Wiener Laboratories Saic
Chemistry · 137d
Cleared Sep 10, 2002
UCR SPINAL SYSTEM, 5.5MM, 8.0MM SCREWS & INSTRUMENTS
K021623 · MNH
Iame, Inc.
Orthopedic · 117d
Cleared Sep 10, 2002
AXYA MEDICAL, INC, MODEL 100 SONIC SCALPEL ULTRASONIC SURGICAL SYSTEM
K021929 · LFL
Axya Medical, Inc.
General & Plastic Surgery · 90d
Cleared Sep 10, 2002
MEDX LCS LASER SERIES
K021985 · NHN
Medx Electronics, Inc.
Physical Medicine · 84d
Cleared Sep 10, 2002
XLTEK SLEEP SYSTEM
K022037 · OLV
Excel Tech. , Ltd.
Neurology · 78d
Cleared Sep 10, 2002
DERMAPAL, UVA 50HZ, UVA 60HZ, UVB BROAD BAND 50HZ, UVB BROAD BAND 60HZ,UVB...
K022104 · FTC
Daavlin Distributing Co.
General & Plastic Surgery · 74d
Cleared Sep 10, 2002
AVAGEN WOUND DRESSING
K022127 · KGN
Integra Lifesciences Corp.
General & Plastic Surgery · 71d
Cleared Sep 10, 2002
IQM (INTELLIGENT QUALITY MANAGEMENT) ON THE GEM PREMIER 3000, CVP...
K022158 · CGA
Instrumentation Laboratory CO
Chemistry · 70d
Cleared Sep 10, 2002
NORMED MINI EXTERNAL FIXATOR SYSTEM
K022230 · HRS
Osteomedics, Inc.
Orthopedic · 62d
Cleared Sep 10, 2002
PGA (POLYGLYCOLIC) SYNTHETIC ABSORBABLE SUTURE U.S.P.
K022664 · GAM
Arc Medical Supplies (Beijing) Co, Ltd.
General & Plastic Surgery · 32d
Cleared Sep 10, 2002
DUALMESH EMERGE & EMERGE PLUS BIOMATERIAL
K022782 · FTL
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 19d
Cleared Sep 09, 2002
ACT III VENTRICULAR CATHETER
K013705 · GWM
Innerspace, Inc.
Neurology · 305d