FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

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

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175,820 results
129169–129192 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 24, 1989
FDL, INC.'S TRANSPORT SYSTEM
K895187 · JTW
Fairleigh Dickinson Laboratories, Inc.
Microbiology · 74d
Cleared Oct 24, 1989
CURAY-FORM
K895222 · EBI
Scientific Pharmaceuticals, Inc.
Dental · 69d
Cleared Oct 24, 1989
LASERMEDIC 1200 RUBY LASER SYSTEM
K895299 · GEX
Lasermetrics, Inc.
General & Plastic Surgery · 60d
Cleared Oct 24, 1989
MODEL DT-BAL, BALANCE SAVER
K895323 · KXO
Spectramed, Inc.
Obstetrics & Gynecology · 56d
Cleared Oct 24, 1989
DR. DRY
K895346 · KPN
Intellitech
Gastroenterology & Urology · 53d
Cleared Oct 24, 1989
ANTIMICROBIAL SUSCEPTIBILITY DISK
K895392 · JTN
Organon Teknika Corp.
Microbiology · 49d
Cleared Oct 24, 1989
PEMACO ECONOMY BASE PLATE WAX-MEDIUM HARD
K895565 · EGD
Pemaco, Inc.
Dental · 48d
Cleared Oct 24, 1989
L.T.C. FEEDING TUBE
K895616 · KNT
Intl. Medical Marketing, Inc.
Gastroenterology & Urology · 35d
Cleared Oct 24, 1989
CONTRAST BACKGROUND MATERIAL
K895681 · GAB
Applied Medical Technologies
General & Plastic Surgery · 33d
Cleared Oct 24, 1989
VESSEL LOOPS
K895682 · GDX
Applied Medical Technologies
General & Plastic Surgery · 33d
Cleared Oct 24, 1989
BERNARD VESSEL APPROXIMATOR
K895683 · HRQ
Applied Medical Technologies
General & Plastic Surgery · 33d
Cleared Oct 24, 1989
VESSEL OCCLUDER
K895726 · GDJ
Applied Medical Technologies
General & Plastic Surgery · 29d
Cleared Oct 24, 1989
BACKGROUND SUCTION MATT
K895727 · NAB
Applied Medical Technologies, Inc.
General & Plastic Surgery · 29d
Cleared Oct 24, 1989
THROMBELASTOGRAPH(R)
K895844 · GKP
Haemoscope Corp.
Hematology · 21d
Cleared Oct 24, 1989
L.T.C. 1000 URINARY DRAINAGE BAG
K895957 · KNX
Intl. Medical Marketing, Inc.
Gastroenterology & Urology · 13d
Cleared Oct 24, 1989
RHEUMELISA ASSAY FOR SS-A/RO AUTOANTIBODIES
K895994 · LJM
Lipogen, Inc.
Immunology · 11d
Cleared Oct 23, 1989
GLYCABEN
K893453 · LCP
Exocell, Inc.
Chemistry · 173d
Cleared Oct 23, 1989
MICRO-PLATE READER, MDX-1
K894400 · JJX
Medix Biotech, Inc.
Chemistry · 96d
Cleared Oct 23, 1989
BT-338N ELECTRONIC CLINICAL THERMOMETER
K894627 · FCI
Integrated Display Technology, Ltd.
Gastroenterology & Urology · 91d
Cleared Oct 23, 1989
RS232 FLOW SENSOR AND SOFTWARE PACKAGE
K894680 · BZG
Tamarac Systems Corp.
Anesthesiology · 90d
Cleared Oct 23, 1989
MILENIA(TM) CORTISOL (MKCO1,5)
K895006 · CGR
Diagnostic Products Corp.
Chemistry · 76d
Cleared Oct 23, 1989
SYSTEMATE CREATININE TEST (CREA) #65413
K895022 · CGX
Em Diagnostic Systems, Inc.
Chemistry · 76d
Cleared Oct 23, 1989
GAUZE SPONGE
K895086 · EFQ
Keilei Intl., Inc.
General & Plastic Surgery · 76d
Cleared Oct 23, 1989
FOLLICLE STIMULATING HORMONE MAB SOLID PHASE COM.
K895108 · CGJ
Bd Becton Dickinson Vacutainer...
Chemistry · 69d