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
78577–78600 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 27, 2001
AFFINITY 38 MICON ARTERIAL FILTER WITH TRILLIUM BIOPASSIVE SURFACE, MODEL 351T
K013084 · DTM
Medtronic Perfusion Systems
Cardiovascular · 13d
Cleared Sep 26, 2001
FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450...
K011877 · HKI
Carl Zeiss Jena GmbH
Ophthalmic · 103d
Cleared Sep 26, 2001
POWDER-FREE BUTADIENE COPOLYMER EXAM GLOVES WITH ALOE, VITAMINS E PH5.5
K011961 · LZA
Shen Wei (Usa), Inc.
General Hospital · 96d
Cleared Sep 26, 2001
BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM
K011970 · CHH
Biosafe Laboratories, Inc.
Chemistry · 93d
Cleared Sep 26, 2001
SONOREAL 3D
K012084 · IYO
Bio Medi Com
Radiology · 85d
Cleared Sep 26, 2001
THE INTUITIVE COLORIMETER
K012298 · NFD
Cerium Optical Technologies, Inc.
Ophthalmic · 68d
Cleared Sep 26, 2001
URISYS 2400 URINE TEST STRIP
K012397 · JIL
Roche Diagnostics Corp.
Chemistry · 61d
Cleared Sep 26, 2001
STERILE NITRILE SURGICAL GLOVES (POWDERED)
K012479 · KGO
Smart Glove Corp. Sdn Bhd
General Hospital · 55d
Cleared Sep 26, 2001
BLY-501 ADAPTOR
K012540 · DPS
Micromedical Industries, Ltd.
Cardiovascular · 50d
Cleared Sep 26, 2001
THE NEXGEN TMT TIBIA, MODELS 00-5886-XXYY, 05-120-XXYY-0
K012866 · JWH
Implex Corp.
Orthopedic · 30d
Cleared Sep 25, 2001
MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01
K010891 · LSK
Digene Corp.
Microbiology · 183d
Cleared Sep 25, 2001
EASY GUIDE ELECTROSURGICAL ACCESS DEVICE
K012004 · GEI
Senorx, Inc.
General & Plastic Surgery · 90d
Cleared Sep 25, 2001
XBO1-824-18/19/20 BIOPSY FORCEPS
K012074 · OCZ
The Olympus Optical Co.
Gastroenterology & Urology · 85d
Cleared Sep 25, 2001
ACCUIMAGE SMARTGATE UPGRADE
K012106 · JAK
Accuimage Diagnostics Corp.
Radiology · 81d
Cleared Sep 25, 2001
HP-ONE
K012411 · LYR
Gi Supply
Microbiology · 57d
Cleared Sep 25, 2001
SUPERSTITCH VASCULAR SUTURING DEVICE
K012865 · GAW
Sutura, Inc.
General & Plastic Surgery · 29d
Cleared Sep 25, 2001
ULTRAFLEX EV HEMOSTASIS INTRODUCER
K012922 · DYB
St Jude Medical
Cardiovascular · 25d
Cleared Sep 25, 2001
MODIFICATION TO: QWH-420 WRIST ARRAY COIL
K013099 · MOS
Mri Devices Corp.
Radiology · 8d
Cleared Sep 24, 2001
MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01
K010892 · LSK
Digene Corp.
Microbiology · 182d
Cleared Sep 24, 2001
MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01
K010893 · LSL
Digene Corp.
Microbiology · 182d
Cleared Sep 24, 2001
PROMAX-XP, TENS AND MICROCURRENT DEVICE
K011017 · GZJ
Rehabilicare, Inc.
Neurology · 173d
Cleared Sep 24, 2001
PORTABLE INTENSIVE CARE UNIT
K012030 · MKJ
Medical Research Laboratories, Inc.
Cardiovascular · 88d
Cleared Sep 24, 2001
VACUETTE EDTA K2 GEL TUBES
K012043 · PJE
Greiner Vacuette North America, Inc.
Chemistry · 87d
Cleared Sep 24, 2001
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN, CHEMOTHERAPY LABELING CLAIM
K012149 · LYY
Allegiance Healthcare Corp.
General Hospital · 76d