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
82057–82080 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 15, 2000
CORDLESS COMPACT MOBILE X-RAY SYSTEM
K002685 · IZL
Medison Radiology Systems, Inc.
Radiology · 18d
Cleared Sep 15, 2000
UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30
K002694 · CDQ
Diagnostic Chemicals , Ltd.
Chemistry · 17d
Cleared Sep 15, 2000
NICORE MODEL ESP -1
K980937 · DRN
Nicore Equipment & Leasing, Inc.
Cardiovascular · 918d
Cleared Sep 14, 2000
THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES
K002177 · JPA
Haemoscope Corp.
Hematology · 57d
Cleared Sep 14, 2000
ACCOLADE C FEMORAL COMPONENT
K002320 · LZO
Howmedica Osteonics Corp.
Orthopedic · 45d
Cleared Sep 14, 2000
BIO-LOGIC CEEGRAPH NETLINK
K002570 · GWQ
Bio-Logic Systems Corp.
Neurology · 27d
Cleared Sep 14, 2000
ASPECT MEDICAL SYTEMS EEG ENHANCED BIS SENSOR 186-0106
K002734 · GXY
Aspect Medical Systems, Inc.
Neurology · 13d
Cleared Sep 14, 2000
14 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD...
K993933 · MPB
Arrow Intl., Inc.
Gastroenterology & Urology · 301d
Cleared Sep 13, 2000
MIDAS TOUCH NITRILE EXAMINATION GLOVES-POWDERFREE
K000138 · LZA
Industrial Clothings, Ltd.
General Hospital · 239d
Cleared Sep 13, 2000
MIDAS TOUCH BLUE NITRILE EXAMINATION GLOVES-POWDERED
K000139 · LZA
Industrial Clothings, Ltd.
General Hospital · 239d
Cleared Sep 13, 2000
MIDAS TOUCH LATEX EXAMINATION GLOVES-POWDERED
K000141 · LYY
Industrial Clothings, Ltd.
General Hospital · 239d
Cleared Sep 13, 2000
MIDAS TOUCH LATEX EXAMINATION GLOVES-POWDER FREE
K000142 · LYY
Industrial Clothings, Ltd.
General Hospital · 239d
Cleared Sep 13, 2000
MIDAS TOUCH NITRILE EXAMINATION GLOVES-POWDERED
K000143 · LZA
Industrial Clothings, Ltd.
General Hospital · 239d
Cleared Sep 13, 2000
MIDAS TOUCH BLUE NITRILE EXAMINATION GLOVES-POWDER FREE
K000145 · LZA
Industrial Clothings, Ltd.
General Hospital · 239d
Cleared Sep 13, 2000
BESTEX POWDER-FREE LATEX EXAM GLOVES WITH LABELING CLAIM. (50 MICROGRAMS OR...
K002087 · LYY
Qingdao Bestex Rubber & Plastic...
General Hospital · 65d
Cleared Sep 13, 2000
ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS)
K002290 · CHL
Radiometer Medical A/S
Chemistry · 48d
Cleared Sep 13, 2000
MOTOR-DRIVE MANIPULATOR MM-89
K002291 · MQJ
Narishige Co., Ltd.
Obstetrics & Gynecology · 48d
Cleared Sep 13, 2000
3D MOTOR-DRIVEN COARSE MANIPULATOR MM-188NE
K002293 · MQJ
Narishige Co., Ltd.
Obstetrics & Gynecology · 48d
Cleared Sep 13, 2000
COOK IVF SPERM BUFFER, COOK IVF SPERM MEDIUM, AND COOK IVF SPERM GRADIENT KIT
K002383 · MQL
Cook Ob/Gyn
Obstetrics & Gynecology · 40d
Cleared Sep 13, 2000
MEDILOG EXCEL 2 - HOLTER MANAGEMENT SYSTEM
K002544 · DQK
Oxford Instruments
Cardiovascular · 27d
Cleared Sep 13, 2000
COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
K002591 · DTP
Cobe Cardiovascular, Inc.
Cardiovascular · 23d
Cleared Sep 13, 2000
METHAFILCON A
K002625 · LPL
CooperVision, Inc.
Ophthalmic · 21d
Cleared Sep 13, 2000
MARIETTA CONTACT LENS SERVICE, COLOR ENHANCED TINTED SOFT CONTACT LENS
K002647 · LPL
Marietta Contact Lens Service
Ophthalmic · 20d
Cleared Sep 13, 2000
MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP...
K002682 · DQA
Masimo Corp.
Anesthesiology · 16d