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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
164545–164568 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 26, 1981
PULSARII, HIGH VOLT. GALVANIC MUSC. STIM
K810064 · IPF
Bomed Medical Mfr., Ltd.
Physical Medicine · 13d
Cleared Jan 26, 1981
ALKALINE PHOSPH., LIQUID ENZY., KIN. KIT
K810082 · CJE
Bio-Analytics Laboratories, Inc.
Chemistry · 13d
Cleared Jan 26, 1981
MAGNESIUM KIT
K810084 · JGJ
Bio-Analytics Laboratories, Inc.
Chemistry · 13d
Cleared Jan 26, 1981
6% ORTHO LOLIUDINE REAGENT IN GLACID ACI
K810089 · CGE
Anco Medical Reagents & Assoc.
Chemistry · 13d
Cleared Jan 26, 1981
CHOLESTEROL REAGENT
K810090 · CGO
Anco Medical Reagents & Assoc.
Chemistry · 13d
Cleared Jan 26, 1981
GLUCOSE STANDARD
K810091 · JIS
Anco Medical Reagents & Assoc.
Chemistry · 13d
Cleared Jan 26, 1981
RESPA-TROL
K810107 · JJS
Intensive Technology, Inc.
Chemistry · 10d
Cleared Jan 26, 1981
METAL SPLINTS
K810109 · ILH
Secol Co.
Physical Medicine · 10d
Cleared Jan 26, 1981
COBBLER'S CHIP SPLINTS
K810110 · LGF
Secol Co.
Orthopedic · 10d
Cleared Jan 23, 1981
VISECERA RETAINER
K802806 · GCZ
Adept-Med Intl., Inc.
General & Plastic Surgery · 77d
Cleared Jan 23, 1981
ERECTAID
K803111 · FAE
Burditt & Calkins-Siemens-Elema
Gastroenterology & Urology · 44d
Cleared Jan 23, 1981
PROSTHESIS, HIP FEMORAL COMPONENT METAL
K803191 · KWL
Osteonics Corp.
Orthopedic · 38d
Cleared Jan 23, 1981
HCL ACETABULAR COMPONENTS
K803192 · KWZ
Osteonics Corp.
Orthopedic · 38d
Cleared Jan 23, 1981
SURG-FLEX 5 SURGICAL LIGHT
K810018 · FSQ
Medical Products Development, Inc.
General & Plastic Surgery · 18d
Cleared Jan 23, 1981
SURG-FLEX 15 SURGICAL LIGHT
K810019 · FSQ
Medical Products Development, Inc.
General & Plastic Surgery · 18d
Cleared Jan 23, 1981
FLO-TEMP
K810021 · FLA
Laminar Flow Industries
Gastroenterology & Urology · 18d
Cleared Jan 23, 1981
BONNER BRACE
K810024 · IQK
Bee Ent.
Physical Medicine · 18d
Cleared Jan 23, 1981
PRENATAL SUPPORT PILLOW
K810035 · CCX
Supportech, Inc.
Anesthesiology · 14d
Cleared Jan 23, 1981
GALVANATOR 725
K810057 · IPF
Avratronics Corp.
Physical Medicine · 10d
Cleared Jan 23, 1981
CURVED SHERMAN BONE PLATE
K810061 · HRS
Howmedica Corp.
Orthopedic · 10d
Cleared Jan 22, 1981
SIRECUST 400 SYSTEM PATIENT MONITORING
K802113 · DPS
Analogic Corp.
Cardiovascular · 141d
Cleared Jan 22, 1981
HP MODEL 4710A ECG TRANSMITTER
K802717 · DXH
Hewlett-Packard Co.
Cardiovascular · 83d
Cleared Jan 22, 1981
SEMI-OVAL MODULAR SUNTANNING BOOTH
K802756 · LEJ
Tannhut
Radiology · 78d
Cleared Jan 22, 1981
TERUMO HOLLOW FIBER OXYGENATOR
K802970 · DTZ
Terumo America, Inc.
Cardiovascular · 62d