FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
79585–79608 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 17, 2001
INVACARE PASSOVER HUMIDIFIER MODEL ISP9700
K003561 · BTT
Invacare Corp.
Anesthesiology · 148d
Cleared Apr 17, 2001
WUJIN #3 FEMORAL NAIL
K010149 · HSB
Biopro, Inc.
Orthopedic · 90d
Cleared Apr 17, 2001
PREMIER ULTRASONIC SCALER AND INSERTS
K010195 · ELC
Premier Dental Products Co.
Dental · 85d
Cleared Apr 17, 2001
Y-TZP POWDER AND PROCERA ALLZIRKON
K010630 · EIH
Procera Sandvik, Inc.
Dental · 46d
Cleared Apr 17, 2001
FG-36UX, FIBER ULTRASOUND GASTROSCOPE
K010740 · ODG
Pentax Precision Instrument Corp.
Radiology · 35d
Cleared Apr 17, 2001
LIVESURE COCAINE SCREEN TEST
K010967 · DIO
Pan Probe Biotech, Inc.
Toxicology · 15d
Cleared Apr 16, 2001
REFLEX ANTERIOR CERVICAL PLATE SYSTEM
K010115 · KWQ
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Apr 13, 2001
LACTOSORB ETHMOID STENT
K002131 · LYA
Walter Lorenz Surgical, Inc.
Ear, Nose, Throat · 273d
Cleared Apr 13, 2001
ADVIA CENTAUR RUBELLA IGG ASSAY
K003412 · LFX
Bayer Corp.
Microbiology · 162d
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