FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
74929–74952 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 07, 2002
CLEARFIL SA PRIMER
K021427 · KLE
Kuraray Medical, Inc.
Dental · 35d
Cleared Jun 07, 2002
SECTRA OSTEOPOROSIS PACKAGE
K021527 · KGI
Sectra-Imtec AB
Radiology · 28d
Cleared Jun 06, 2002
OXYHEAL 2000 HYPERBARIC CHAMBER SERIES, MODEL OXYHEAL 2000 SERIES
K011866 · CBF
Hyperbaric Technologies, Inc.
Anesthesiology · 357d
Cleared Jun 06, 2002
SAFE SHIELD PRE-POWDERED LATEX EXAMINATION GLOVES
K013980 · LYY
Safe Shield Co., Ltd.
General Hospital · 185d
Cleared Jun 06, 2002
HBS HEADLESS BONE SCREW
K020791 · HWC
Millennium Medical Technologies, Inc.
Orthopedic · 87d
Cleared Jun 06, 2002
SCORPIO INSET PATELLAR COMPONENT
K020830 · JWH
Howmedica Osteonics Corp.
Orthopedic · 84d
Cleared Jun 06, 2002
GPF-29 GENERAL PURPOSE COIL SET
K020850 · MOS
Mri Devices Corp.
Radiology · 83d
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