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
69841–69864 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 10, 2004
RNK TELEPHONIC STETHOSCOPE, MODEL TR-1
K034046 · DQD
Rnk Products
Cardiovascular · 72d
Cleared Mar 10, 2004
R&D GLU-LINE HEMATOLOGY CONTROL
K034048 · JJX
R&D Systems, Inc.
Chemistry · 71d
Cleared Mar 10, 2004
HEALTH BUDDY WITH BUDDYLINK
K040086 · DXN
Health Hero Network, Inc.
Cardiovascular · 54d
Cleared Mar 10, 2004
LIQUICHEK CARDIAC MARKER CONTROL LT
K040277 · JJY
Bio-Rad Laboratories, Inc.
Chemistry · 34d
Cleared Mar 10, 2004
ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2
K040431 · DAO
Roche Diagnostics Corp.
Immunology · 20d
Cleared Mar 10, 2004
ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2
K040434 · DEW
Roche Diagnostics Corp.
Immunology · 20d
Cleared Mar 10, 2004
ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2
K040435 · CZP
Roche Diagnostics Corp.
Immunology · 20d
Cleared Mar 10, 2004
OLYMPUS LDL CHOLESTEROL REAGENT, OSR6196/OSR6296
K040471 · JIT
Olympus America, Inc.
Chemistry · 15d
Cleared Mar 10, 2004
ORAVIVE TOOTH REVITALIZING PASTE
K040473 · LBH
Novamin Technology, Inc.
Dental · 15d
Cleared Mar 09, 2004
PROFILE 1320 LASER SYSTEM
K032459 · GEX
Sciton, Inc
General & Plastic Surgery · 211d
Cleared Mar 09, 2004
ARROWHEAD SPINAL SYSTEM
K032560 · NKB
Medtronic Sofamor Danek
Orthopedic · 202d
Cleared Mar 09, 2004
SOHNIKS
K033191 · FAJ
Sohniks Endoscopy, Inc.
Gastroenterology & Urology · 160d
Cleared Mar 09, 2004
BONESAVE BONE VOID FILLER
K033258 · MQV
Howmedica Osteonics
Orthopedic · 152d
Cleared Mar 09, 2004
MIDAS TOUCH BLUE LATEX EXAMINATION GLOVES - POWDER FREE FOR CHEMOTHERAPY USE
K033496 · LYY
Industrial Clothings, Ltd.
General Hospital · 125d
Cleared Mar 09, 2004
INFINITYEDICAL INFORMATION BUS (MIB/MIB II AND MIB DUO) PROTOCOL CONVERTER
K033807 · DRQ
Draeger Medical Systems, Inc.
Cardiovascular · 92d
Cleared Mar 09, 2004
BD PROBETEC ET LEGIONELLA PNEUMOPHILA (LP) AMPLIFIED DNA ASSAY
K033861 · LQH
Becton, Dickinson & CO
Microbiology · 88d
Cleared Mar 09, 2004
ULTRAFLEX INFUSION SET
K033892 · FPA
Disetronic Medical Systems AG
General Hospital · 84d
Cleared Mar 09, 2004
TELETHERMOGRAPHIC CAMERA, SERIES A, E, S AND P
K033967 · LHQ
Flir Systems
Radiology · 78d
Cleared Mar 09, 2004
LACRYTEST
K034057 · DGC
Adiatec SA
Immunology · 70d
Cleared Mar 09, 2004
SECTRA ANGIOGRAPHY PACKAGE AND SECTRA CARDIOLOGY PACKAGE
K034059 · LLZ
Sectra AB
Radiology · 69d
Cleared Mar 09, 2004
STEERABLE STYLET
K040001 · DRB
Synovis Surgical Innovations
Cardiovascular · 67d
Cleared Mar 09, 2004
THERILINK BONE VOID FILLER
K040134 · MQV
Therics, Inc.
Orthopedic · 48d
Cleared Mar 09, 2004
VERSAPOINT RESECTOSCOPIC SYSTEM
K040302 · HIH
Gynecare, A Div. of Ethicon, Inc.
Obstetrics & Gynecology · 29d
Cleared Mar 09, 2004
SIREMOBIL ISO-C 3D
K040347 · OXO
Siemens Medical Systems, Inc.
Radiology · 26d