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
77185–77208 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 13, 2001
DXS DIGITAL X-RAY SYSTEM
K013271 · MUH
Douglas C. Yoon, Dds
Radiology · 73d
Cleared Dec 13, 2001
ENDOFLIP
K013334 · MBI
Arthocare Corporation
Orthopedic · 65d
Cleared Dec 13, 2001
PRIZM KERATOME BLADE (NIDEK MODEL), MODEL MK8514NI
K013337 · HNO
Surgin, Inc.
Ophthalmic · 65d
Cleared Dec 13, 2001
DYNAPULSE 5000A MINI ABP BLOOD PRESSURE MONITORING SYSTEM
K013358 · DXN
Pulse Metric, Inc.
Cardiovascular · 64d
Cleared Dec 13, 2001
CARDIOCOLLECT PORTABLE ELECTROCARDIOGRAPH
K013367 · DPS
Reynolds Medical , Ltd.
Cardiovascular · 64d
Cleared Dec 13, 2001
INDIGO OPTIMA LASER SYSTEM
K013493 · GEX
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 52d
Cleared Dec 13, 2001
INVACARE ELEVATING SEAT OPTION ESS6
K013516 · ITI
Invacare Corp.
Physical Medicine · 51d
Cleared Dec 13, 2001
CRYSTAL 5000 PHASES ARRAY TMJ COIL
K013528 · MOS
Usa Instruments, Inc.
Radiology · 51d
Cleared Dec 13, 2001
MODIFICATION TO EBI XFIX DFS SYSTEM
K013739 · LXT
Ebi, L.P.
Orthopedic · 30d
Cleared Dec 13, 2001
ULTRASAFE DENTAL INJECTION SYSTEM
K013801 · MEG
Safety Syringes, Inc.
General Hospital · 28d
Cleared Dec 13, 2001
MEDRAD QWIK-FIT SYRINGE
K013815 · DXT
Medrad, Inc.
Cardiovascular · 27d
Cleared Dec 13, 2001
IMMUNO-TROL LOW CELLS
K013842 · JPK
Beckman Coulter, Inc.
Hematology · 23d
Cleared Dec 13, 2001
ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS
K013935 · LZO
Sulzer Orthopedics, Inc.
Orthopedic · 15d
Cleared Dec 13, 2001
NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID HORMONE (1-84)...
K013992 · CEW
Nichols Institute Diagnostics
Chemistry · 9d
Cleared Dec 12, 2001
BIOSPEED
K013069 · FCG
H.S. Hospital Services S.P.A.
Gastroenterology & Urology · 90d
Cleared Dec 12, 2001
JAMSHIDI BIOPSY NEEDLE
K013070 · FCG
H.S. Hospital Services S.P.A.
Gastroenterology & Urology · 90d
Cleared Dec 12, 2001
SECURCUT ASPIRATION BIOPSY NEEDLE
K013071 · FCG
H.S. Hospital Services S.P.A.
Gastroenterology & Urology · 90d
Cleared Dec 12, 2001
SYNCHRON SYSTEMS VANCOMYCIN REAGENT
K013076 · LEH
Beckman Coulter, Inc.
Toxicology · 89d
Cleared Dec 12, 2001
SAS STREPALERT
K013379 · GTY
Sa Scientific, Inc.
Microbiology · 61d
Cleared Dec 12, 2001
PULPDENT CAVITY PREPARATION IV
K013411 · LBH
Pulpdent Corp.
Dental · 58d
Cleared Dec 12, 2001
MICROSCAN DRIED GRAM NEGATIVE OVERNIGHT MIC/COMBO PANELS
K013423 · JWY
Dade Microscan, Inc.
Microbiology · 71d
Cleared Dec 12, 2001
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE
K013580 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 44d
Cleared Dec 12, 2001
SIMPLICITY INFUSION RESERVOIR FOR USE TO INFUSE MEDICINE, INCLUDING INSULIN,...
K013767 · FRN
Sterling Medivations, Inc.
General Hospital · 29d
Cleared Dec 12, 2001
MICROJET QUARK, MODEL U100 OR U40
K013807 · LZG
Cane S.R.L.
General Hospital · 27d