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
79561–79584 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 20, 2001
BEAUTIFIL
K010914 · EBF
Shofu Dental Corp.
Dental · 24d
Cleared Apr 20, 2001
EMIT II PLUS BARBITUATE ASSAY, MODEL 0SR9D0229
K010934 · DIS
Syva Co., Dade Behring, Inc.
Toxicology · 23d
Cleared Apr 20, 2001
NEURO N100 RADIOFREQUENCY GENERATOR AND ACCESSORY CABLES
K010969 · GXD
Stryker Instruments
Neurology · 18d
Cleared Apr 20, 2001
EMIT 2000 GENTAMICIN PLUS ASSAY
K010984 · LCD
Syva Co., Dade Behring, Inc.
Toxicology · 18d
Cleared Apr 20, 2001
SAFESTING AND SAFESTING HUB
K011003 · FPA
Diasol, Inc.
General Hospital · 16d
Cleared Apr 20, 2001
OPTIMA
K011053 · ITI
Medical Industries America, Inc.
Physical Medicine · 14d
Cleared Apr 19, 2001
DISPO-MED 7.6 LITER SHARPS CONTAINER
K003521 · FMI
Master Benefits, Inc.
General Hospital · 156d
Cleared Apr 19, 2001
BD ULTRA-FINE II INSULIN SYRINGE-MINI NEEDLE, MODEL 30G * 3/16 (5MM)
K010890 · FMF
Becton, Dickinson and Co.
General Hospital · 24d
Cleared Apr 18, 2001
TRIDENT POROUS TITANIUM ACETABULAR COMPONENT
K010170 · LPH
Howmedica Osteonics Corp.
Orthopedic · 90d
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