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
75553–75576 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 26, 2002
FOSSA URETERAL STONE SWEEPER
K021602 · FAD
Fossa Industries, Inc.
Gastroenterology & Urology · 72d
Cleared Jul 26, 2002
ILT ADVANCING MECHANISM, MODEL A115AMI
K021638 · DQX
Intra Luminal Therapeutics, Inc.
Cardiovascular · 67d
Cleared Jul 26, 2002
XTD THROMBECTOMY CATHETER, XX CM
K021641 · QEW
Xtrak Medical, Inc.
Cardiovascular · 67d
Cleared Jul 26, 2002
CHROLOY SOLDER
K021965 · EJH
Neirynck & Vogt NV
Dental · 39d
Cleared Jul 26, 2002
CERALOY SOLDER
K021968 · EJH
Neirynck & Vogt NV
Dental · 39d
Cleared Jul 26, 2002
ELPH INJECTION SYSTEM
K022116 · DXT
Mallinckrodt Inc., Liebel-Flarsheim...
Cardiovascular · 25d
Cleared Jul 26, 2002
ZETA DIAGNOSTIC RETINAL IMAGING SYSTEM
K022164 · HKI
Zeta Development Laboratories
Ophthalmic · 23d
Cleared Jul 25, 2002
WU'S 3-WHEELED NEO SCOOTER, WT-M3
K014119 · INI
Wu'S Tech Co., Ltd.
Physical Medicine · 220d
Cleared Jul 25, 2002
MULTIGAS UNIT, MODEL AG-920RA
K020046 · CCK
Nihon Kohden America, Inc.
Anesthesiology · 199d
Cleared Jul 25, 2002
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K021061 · KWP
Medtronic Sofamor Danek
Orthopedic · 114d
Cleared Jul 25, 2002
ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2
K021316 · LBS
Genzyme Corp.
Chemistry · 91d
Cleared Jul 25, 2002
ORTHOPILOT HTO MODULE
K021327 · HAW
Aesculap, Inc.
Neurology · 90d
Cleared Jul 25, 2002
MAGNETOM TRIO QUADRATURE TX/RX HEAD COIL
K021330 · MOS
Usa Instruments, Inc.
Radiology · 90d
Cleared Jul 25, 2002
NOVABONE-RESORBABLE BONE GRAFT SUBSTITUTE
K021336 · MQV
Novabone Products, LLC
Orthopedic · 90d
Cleared Jul 25, 2002
TUTTNAUER EHS SERIES TABLE-TOP AUTOCLAVE, MODEL 2540
K021504 · FLE
Tuttnauer U.S.A Co, Ltd.
General Hospital · 77d
Cleared Jul 25, 2002
K-ASSAY LP(A) ASSAY
K021660 · DFC
Kamiya Biomedical Co.
Chemistry · 66d
Cleared Jul 25, 2002
STAT PROFILE PHOX PLUS C ANALYZER
K021713 · CHL
Nova Biomedical Corp.
Chemistry · 63d
Cleared Jul 25, 2002
BRIGHT GOLD
K021892 · EJT
Ivoclar Vivadent, Inc.
Dental · 48d
Cleared Jul 25, 2002
CLARREN HELMET (ORTHOMERICA)
K021918 · OAN
Orthomerica Products, Inc.
Neurology · 44d
Cleared Jul 25, 2002
AUROPAL 60
K021926 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 43d
Cleared Jul 25, 2002
36MM V40 FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT)
K022077 · JDI
Howmedica Osteonics Corp.
Orthopedic · 29d
Cleared Jul 25, 2002
J&S MEDICAL SENTRY URINE DIPSTICK CONTROL
K022085 · JJW
J & S Medical Assoc., Inc.
Chemistry · 28d
Cleared Jul 25, 2002
PAR 5 ACETABULAR COMPONENT WITH & WITHOUT HYDROXYAPATITE COATING
K022094 · JDI
Biomet, Inc.
Orthopedic · 28d
Cleared Jul 25, 2002
THERMO DMA DATA-CAL CALIBRATOR, MODEL 1905-050
K022108 · JIX
Thermo Dma, Inc.
Chemistry · 27d