FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
75433–75456 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 10, 2002
(MULTIPLE LABELS) POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: YELLOW
K021743 · LZA
Copioumed Intl., Inc.
General Hospital · 13d
Cleared Jun 10, 2002
MODIFICATION TO BLUE SKY DENTAL IMPLANT SYSTEM
K021833 · DZE
Blue Sky Bio
Dental · 6d
Cleared Jun 10, 2002
SYNTHES (USA) 1.3 MM CRANIOFACIAL SCREWS
K021850 · DZL
Synthes (Usa)
Dental · 5d
Cleared Jun 07, 2002
INSIGHT, MODEL S980000
K012232 · FFX
Sandhill Scientific, Inc.
Gastroenterology & Urology · 326d
Cleared Jun 07, 2002
DUPLOREACH
K014088 · FMF
Baxter Healthcare Corp
General Hospital · 177d
Cleared Jun 07, 2002
TELESIS DIGITAL INFRARED THERMAL IMAGE SYSTEM, SPECTRUM 9000MB
K020783 · LHQ
Telesis Technologies, Inc.
Radiology · 88d
Cleared Jun 07, 2002
VERAVIEWEPOCS PANORAMIC X-RAY UNIT WITH CEPHALOMETRIC CAPABILITY
K021372 · EAG
J. Morita USA, Inc.
Radiology · 38d
Cleared Jun 07, 2002
PORTABLE HDX INTRAORAL X-RAY
K021378 · EHD
Dentalez Group
Radiology · 37d
Cleared Jun 07, 2002
LATEX EXAMINATION GLOVES, POWDER FREE, POLYMER COATED
K021412 · LYY
Arista Latindo Industrial Ltd. P.T
General Hospital · 35d
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