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
70225–70248 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 30, 2004
ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZYME...
K033606 · NBC
Axis-Shield Diagnostics, Ltd.
Chemistry · 74d
Cleared Jan 30, 2004
OLYMPUS VIDEO URETEROSCOPE, NTSC
K033651 · FGB
Olympus Winter & Ibe GmbH
Gastroenterology & Urology · 71d
Cleared Jan 30, 2004
MTS MULTIPROGRAM TRIAL STIMULATOR SYSTEM
K033757 · GZB
Advanced Neuromodulation Systems
Neurology · 60d
Cleared Jan 30, 2004
KURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BS
K033796 · KHJ
Heinz Kurz GmbH Medizintechnik
Ear, Nose, Throat · 56d
Cleared Jan 30, 2004
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZER
K033811 · DEH
The Binding Site, Ltd.
Immunology · 52d
Cleared Jan 30, 2004
OLYMPUS URINE CALIBRATOR
K033910 · JIX
Cliniqa Corporation
Chemistry · 44d
Cleared Jan 30, 2004
FLOSENSE II, MODEL 29-8040
K033939 · BZG
Sdi Diagnostics, Inc.
Anesthesiology · 46d
Cleared Jan 30, 2004
UCLA AND CEMENT-ON ABUTMENTS AND ACCESSORIES
K034022 · DZE
Diamodent
Dental · 32d
Cleared Jan 30, 2004
MODIFICATION TO CONVOY ADVANCED DELIVERY SHEATH
K034061 · DYB
Boston Scientific Corp
Cardiovascular · 30d
Cleared Jan 30, 2004
CP SLEEVE AND RIVER SLEEVE
K034062 · KXK
Cp Medical
Radiology · 30d
Cleared Jan 30, 2004
FRESENIUS ULTRAFLO HPX HEMODIALYZER
K034064 · KDI
Fresenius Medical Care North America
Gastroenterology & Urology · 30d
Cleared Jan 30, 2004
PICCOLO MAGNESIUM TEST SYSTEM
K040115 · JGJ
Abaxis, Inc.
Chemistry · 10d
Cleared Jan 30, 2004
EMORY CARDIAC TOOLBOX VERSION 2.6
K040141 · KPS
Syntermed, Inc.
Radiology · 8d
Cleared Jan 29, 2004
MULTIPLACE HYPERBARIC SYSTEM, MODEL MMI HYPERBARIC CHAMBER SYSTEM
K030418 · CBF
Makai Marine Industries, Inc.
Anesthesiology · 353d
Cleared Jan 29, 2004
HOLOTC RIA
K030655 · CDD
Axis-Shield Biochemicals, Asa
Chemistry · 332d
Cleared Jan 29, 2004
MEDONIC CA620/530 HEMATOLOGY ANALYZER
K032214 · GKZ
Boule Medical AB
Hematology · 192d
Cleared Jan 29, 2004
SCALETRON PIEZO ULTRASOUND SCALER
K033120 · ELC
Pac-Dent International (Suzhou), Ltd.
Dental · 121d
Cleared Jan 29, 2004
BD CAREFLOW CENTRAL VENOUS CATHETER
K033500 · FOZ
Becton, Dickinson & CO
General Hospital · 85d
Cleared Jan 29, 2004
CLEARFIL PROTECT BOND
K033938 · KLE
Kuraray Medical, Inc.
Dental · 41d
Cleared Jan 29, 2004
SPHERICAL TIP CORONARY OSTIAL CANNULA, MODEL 30011
K034058 · DWF
Medtronic Vascular
Cardiovascular · 30d
Cleared Jan 29, 2004
ABBOTT DATA PORT PC, MODEL 12181
K040114 · FRN
Abbott Laboratories
General Hospital · 9d
Cleared Jan 28, 2004
SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000
K023713 · KRC
Sontra Medical, Inc.
Cardiovascular · 450d
Cleared Jan 28, 2004
HIGH PRECISION BODY WEIGHT MONITOR WITH BODY FAT INDEX
K031167 · MNW
Idt Technology Limited
Gastroenterology & Urology · 289d
Cleared Jan 28, 2004
SECUMAX BLOOD COLLECTION SYSTEM
K032141 · FMI
Tiger Meditech Incorporated
General Hospital · 201d