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
80209–80232 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 13, 2001
AVL HINGE KNEE SYSTEM
K010774 · KRO
Biomet, Inc.
Orthopedic · 30d
Cleared Apr 13, 2001
NIAGARA SLIM-CATH
K010778 · MPB
C.R. Bard, Inc.
Gastroenterology & Urology · 29d
Cleared Apr 13, 2001
3M ESPE HAUR
K010781 · EBF
3M Company
Dental · 29d
Cleared Apr 13, 2001
EMIT 2000 PROCAINAMIDE ASSAY, MODEL OSR4K229
K010812 · LAR
Syva Co., Dade Behring, Inc.
Chemistry · 25d
Cleared Apr 13, 2001
EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229
K010814 · KLT
Syva Co., Dade Behring, Inc.
Toxicology · 25d
Cleared Apr 13, 2001
COBRA 1/2 FLEX SURGICAL PROBE, MODEL 1593X
K010956 · GEI
Boston Scientific Corp
General & Plastic Surgery · 14d
Cleared Apr 13, 2001
VERDICT -II BAR
K010959 · DIS
Medtox Diagnostics, Inc.
Toxicology · 14d
Cleared Apr 13, 2001
LIVESURE MORPHINE SCREEN TEST
K011011 · DOE
Pan Probe Biotech, Inc.
Toxicology · 9d
Cleared Apr 12, 2001
UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SET
K000592 · FPA
Myco Medical Supplies, Inc.
General Hospital · 415d
Cleared Apr 12, 2001
LASER MECHANISMS LASER SCANNING SYSTEM
K010113 · GEX
Laser Mechanisms, Inc.
General & Plastic Surgery · 86d
Cleared Apr 12, 2001
VISTAKON (METHAFILCON A) CONTACT LENSES
K010507 · LPL
Vistakon
Ophthalmic · 50d
Cleared Apr 12, 2001
RX HERCULINK PLUS BILIARY STENT SYSTEM
K010684 · FGE
Guidant Corp.
Gastroenterology & Urology · 35d
Cleared Apr 12, 2001
MOSS MIAMI 5.5MM TITANIUM PIN NUT
K010742 · MNH
Depuyacromed
Orthopedic · 30d
Cleared Apr 12, 2001
CH 2000 CARDIAC DIAGNOSTIC SYSTEM
K010756 · DQK
Cambridge Heart, Inc.
Cardiovascular · 30d
Cleared Apr 12, 2001
HEARTWAVE ALTERNANS PROCESSING SYSTEM, APS
K010758 · DPS
Cambridge Heart, Inc.
Cardiovascular · 30d
Cleared Apr 12, 2001
SIMPLICITY SILVER SET SOFT INFUSION
K010846 · FPA
Sterling Medivations, Inc.
General Hospital · 22d
Cleared Apr 12, 2001
R-SI-LINE METAL-BITE
K010926 · ELW
R-Dental Dentalerzeugnisse GmbH
Dental · 16d
Cleared Apr 12, 2001
U04
K010942 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 14d
Cleared Apr 11, 2001
FIESTA IMAGING OPTION
K002997 · LNH
GE Medical Systems
Radiology · 197d
Cleared Apr 11, 2001
BIPOLAR TRIGGER-FLEX PROBE
K003126 · GEI
Ellman Intl., Inc.
General & Plastic Surgery · 188d
Cleared Apr 11, 2001
FUNET AMY MAMA BODY THERMOMETER
K003326 · FLL
Funai Radio & Communications Corp.
General Hospital · 169d
Cleared Apr 11, 2001
SOCON SPINAL SYSTEM
K003463 · MNH
Aesculap, Inc.
Orthopedic · 155d
Cleared Apr 11, 2001
CANDELA LONG PULSE ND:YAG
K010104 · GEX
Candela Corp.
General & Plastic Surgery · 89d
Cleared Apr 11, 2001
ACUVUE 2 BRAND (ETAFILCON A) CONTACT LENS, WITH UV BLOCKER TINTED (TO MASK OR...
K010114 · LPL
Johnson & Johnson Vision Care, Inc.
Ophthalmic · 85d