FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
79081–79104 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 13, 2001
PRESCOTT'S SURGICAL SPEAR
K003842 · HOZ
Prescott'S, Inc.
Ophthalmic · 122d
Cleared Apr 13, 2001
KSEA UNIDRIVE II/II PLUS AND ENT ACCESSORIES
K003994 · ERL
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 108d
Cleared Apr 13, 2001
ANEUVYSION MULITICOLOR DNA PROBE KIT
K010288 · OYU
Vysis
Pathology · 72d
Cleared Apr 13, 2001
IL TEST FREE PROTEIN S
K010379 · GGP
Instrumentation Laboratory CO
Hematology · 64d
Cleared Apr 13, 2001
WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND...
K010421 · KNK
Wiener Laboratories Saic
Chemistry · 60d
Cleared Apr 13, 2001
SIMPLICITY INFUSER INFUSION SET
K010647 · FPA
Sterling Medivations, Inc.
General Hospital · 39d
Cleared Apr 13, 2001
COULTER HMX ANALYZER, MODEL 6605523, COULTER HMX WITH AUTOLOADER, MODEL 6605526
K010765 · GKZ
Beckman Coulter, Inc.
Hematology · 30d
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