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
76057–76080 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 06, 2002
M3 (MICRO-MULTILEAF COLLIMATOR)
K020860 · IYE
Brainlab AG
Radiology · 80d
Cleared Jun 06, 2002
STERILE DISPOSABLE VINYL EXAM GLOVES, POWDER FREE
K020943 · LYZ
Shanghai Antares Industries, Inc.
General Hospital · 73d
Cleared Jun 06, 2002
DCM 2.0
K020971 · MUJ
Mds Nordion AB
Radiology · 72d
Cleared Jun 06, 2002
VALVED PEELABLE INTRODUCER
K021004 · DYB
Medamicus, Inc.
Cardiovascular · 70d
Cleared Jun 06, 2002
MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE
K021010 · OCL
Endocare, Inc.
Cardiovascular · 69d
Cleared Jun 06, 2002
MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS
K021021 · JAA
Siemens Medical Solutions USA, Inc.
Radiology · 69d
Cleared Jun 06, 2002
FILMSAVER, NT VERSION 5.03
K021072 · LLZ
American Medical Resources, Ltd. (Amr)
Radiology · 65d
Cleared Jun 06, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-ERYTHROMYCIN
K021078 · LTT
Dade Microscan, Inc.
Microbiology · 64d
Cleared Jun 06, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL- CEFTRIAXONE
K021110 · JWY
Dade Microscan, Inc.
Microbiology · 62d
Cleared Jun 06, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFOTAXIME
K021111 · LTT
Dade Microscan, Inc.
Microbiology · 62d
Cleared Jun 06, 2002
MICROSTREP PLUS PANEL, AZITHROMYCIN
K021169 · JWY
Dade Microscan, Inc.
Microbiology · 56d
Cleared Jun 06, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CEFEPIME
K021188 · JWY
Dade Microscan, Inc.
Microbiology · 52d
Cleared Jun 06, 2002
NITRILE PATIENT EXAMINATION GLOVE POWDER-FREE (BLUE COLOR) TESTED FOR USE...
K021220 · LZA
Siam Sempermed Corp., Ltd.
General Hospital · 76d
Cleared Jun 06, 2002
POWDER-FREE-VINYL EXAMINATION GLOVES, COLOR: WHITE
K021353 · LYZ
Glormed Intl., Inc.
General Hospital · 41d
Cleared Jun 06, 2002
ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE
K021445 · JWY
Ab Biodisk
Microbiology · 31d
Cleared Jun 06, 2002
ARROW INTRA-AORTIC BALLOON (IAB) CATHETER WITH A FIBER OPTIC SENSOR AND A...
K021462 · DSP
Arrow Intl., Inc.
Cardiovascular · 30d
Cleared Jun 06, 2002
MODEL 1133 IVD PC VERSION
K021463 · IYE
Sun Nuclear Corp.
Radiology · 30d
Cleared Jun 06, 2002
GDC POWER SUPPLY, MODEL GDC POWER SUPPLY: 451007-4
K021494 · HCG
Boston Scientific, Target
Neurology · 28d
Cleared Jun 06, 2002
OSCAR, MODEL OE3000
K021502 · LZV
Orthosonics, Ltd.
Orthopedic · 28d
Cleared Jun 06, 2002
POWDERED (BLUE) NITRILE PATIENT EXAMINATION GLOVES
K021506 · LZA
Shijiazhuang Great Vision Plastic...
General Hospital · 28d
Cleared Jun 06, 2002
PAINDOC
K021518 · GZB
Advanced Neuromodulation Systems
Neurology · 27d
Cleared Jun 06, 2002
ARTHROCARE CONTROLLER, AUTHROCARE CABLE, FOOT CONTROL, POWER CORD, WANDS
K021519 · GEI
Arthrocare Corp.
General & Plastic Surgery · 27d
Cleared Jun 06, 2002
VAXCEL PICC WITH PASV VALVE TECHNOLOGY
K021704 · LJS
Catheter Innovations, Inc.
General Hospital · 14d
Cleared Jun 05, 2002
PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER
K013654 · JJF
Precision Systems, Inc.
Toxicology · 211d