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
79057–79080 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 18, 2001
LEAD BLOCKS
K010172 · IXI
Arplay Medical S.A.
Radiology · 90d
Cleared Apr 18, 2001
TRAY ADAPTERS, MULTIPLE
K010174 · IYE
Arplay Medical S.A.
Radiology · 90d
Cleared Apr 18, 2001
SONOPET MODEL UST-2001 ULTRASONIC SURGICAL ASPIRATOR
K010309 · LFL
Mutoh America Co., Ltd.
General & Plastic Surgery · 76d
Cleared Apr 18, 2001
TEMP SCAN
K010383 · FLL
Tenghi Co., Ltd.
General Hospital · 69d
Cleared Apr 18, 2001
ILT DEFLECTING CATHETER, MODEL C114ND1
K010531 · DQY
Intra Luminal Therapeutics, Inc.
Cardiovascular · 54d
Cleared Apr 18, 2001
SIMPLICITY WINGED QD INFUSION SET
K010676 · FPA
Sterling Medivations, Inc.
General Hospital · 43d
Cleared Apr 18, 2001
DORNIR LC-1 CPAP SYSTEM
K010704 · BZD
Prym Medical , Ltd.
Anesthesiology · 40d
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