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
76033–76056 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 10, 2002
CEFAR MEDICAL AB CEFAR PRIMO
K020803 · GZJ
Cefar Medical AB
Neurology · 90d
Cleared Jun 10, 2002
MARKNEW PRODUCTS ACUPUNCTURE NEEDLES
K020880 · MQX
Marknew Products
General Hospital · 84d
Cleared Jun 10, 2002
STARTOX DRUG OF ABUSE SCREENING TEST
K021006 · DKZ
Starplex Scientific, Inc.
Toxicology · 74d
Cleared Jun 10, 2002
TERUMO GAS FILTER
K021020 · CAH
Terumo Cardiovascular Systems Corp.
General Hospital · 73d
Cleared Jun 10, 2002
MODIFICATION TO N/T RHEUMATOLOGY CONTROLS SL 1 & 2
K021381 · JJY
Dade Behring, Inc.
Immunology · 40d
Cleared Jun 10, 2002
CASHMERE NON-STERILE, POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES...
K021388 · LYY
Seal Polymer Industries Bhd.
General Hospital · 39d
Cleared Jun 10, 2002
DERMAGRIP AND MULTIPLE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH...
K021536 · LYY
Wrp Specialty Products Sdn. Bhd.
General Hospital · 31d
Cleared Jun 10, 2002
ELASTYLITE SYNTHETIC POWDERED SURGICAL GLOVE
K021598 · KGO
Eci Medical Technologies, Inc.
General Hospital · 26d
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