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
80185–80208 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 18, 2001
DEPUY PRESERVATION UNICONDYLAR KNEE PROSTHESIS
K010810 · HRY
DePuy Orthopaedics, Inc.
Orthopedic · 30d
Cleared Apr 18, 2001
AB CARDIETTE START 200 HV
K010822 · DPS
H&C Medical Devices Spa
Cardiovascular · 30d
Cleared Apr 18, 2001
CLS VARUS STEM/CLS 135 STEM
K010839 · LZO
Sulzer Orthopedics, Inc.
Orthopedic · 28d
Cleared Apr 18, 2001
MODIFICATION TO OSTEONICS SPINAL SYSTEM
K010845 · MNH
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared Apr 18, 2001
GUIDER SOFTIP GUIDING CATHETER XF 5F
K010853 · DQY
Boston Scientific, Target
Cardiovascular · 28d
Cleared Apr 18, 2001
MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6
K010878 · LGC
Diagnostic Products Corp.
Microbiology · 30d
Cleared Apr 17, 2001
OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER, MODEL 2100 AND DIGITAL...
K002036 · DQA
Osi Medical, Inc.
Anesthesiology · 286d
Cleared Apr 17, 2001
DORNIER COMPACT ALPHA LITHOTRIPTER
K002929 · LNS
Dornier Medtech America, Inc.
Gastroenterology & Urology · 209d
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