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
137017–137040 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 14, 1988
ACE/FISHER PERCUTANEOUS TRANSFIXING PINS
K875022 · JDW
Buckman Co., Inc.
Orthopedic · 41d
Cleared Jan 14, 1988
ORTHOMET BONE PLATES
K875086 · HRS
Orthomet, Inc.
Orthopedic · 36d
Cleared Jan 14, 1988
J&J SCALP VEIN INFUSION SETS
K875177 · FOZ
Critikon Company, LLC
General Hospital · 23d
Cleared Jan 14, 1988
ULTRA TAN PURPLE MINT
K875189 · LEJ
Ultra Tan Intl. AB
General & Plastic Surgery · 28d
Cleared Jan 14, 1988
ULTRA TAN PURPLE PRO
K875190 · LEJ
Ultra Tan Intl. AB
General & Plastic Surgery · 28d
Cleared Jan 13, 1988
SIEMENS SONODYNATOR 834, ULTRASOUND/STIMULATION
K872909 · IMG
Elmed, Inc.
Physical Medicine · 173d
Cleared Jan 12, 1988
SPECTRAMED DISPOSABLE TRANSDUCER (DT-XXO) & ACCESS
K873168 · DRS
Spectramed, Inc.
Cardiovascular · 154d
Cleared Jan 12, 1988
OPTEC STAIN CHARACTERIZATION AND MODIFICATION KIT
K874162 · EBF
Pentron Corp.
Dental · 91d
Cleared Jan 12, 1988
PATTERN DISCRIMINATION PERIMETER
K874336 · HPT
Lkc Technologies, Inc.
Ophthalmic · 82d
Cleared Jan 12, 1988
ANGIOMED INTRODUCING SETS
K874771 · DWB
Angiomed U.S., Inc.
Cardiovascular · 54d
Cleared Jan 12, 1988
SWEDE CHAMP (WHEELCHAIR)
K875034 · IOR
Etac Us, Inc.
Physical Medicine · 36d
Cleared Jan 12, 1988
SWEDE PETITE (WHEELCHAIR)
K875035 · IOR
Etac Us, Inc.
Physical Medicine · 36d
Cleared Jan 12, 1988
MONOJECT SAMPLETTE AMBER CAPILLARY SERUM SEPARATOR
K875061 · GIO
Sherwood Medical Co.
Hematology · 34d
Cleared Jan 12, 1988
DISPOSABLE STERILE SYRINGE FILTERS
K875122 · KET
Corning Medical & Scientific
Pathology · 28d
Cleared Jan 12, 1988
COLUMBIA BLOOD AGAR P3308/ COLUMBIA CNA P3750
K875136 · JSG
Lakewood Biochemical Co., Inc.
Microbiology · 28d
Cleared Jan 12, 1988
ACUSYST-P/3X
K875151 · KJH
Endotronics, Inc.
Pathology · 28d
Cleared Jan 11, 1988
SONOLAYER-V, SAL-38B
K872288 · IYO
Toshiba Medical Systems
Radiology · 209d
Cleared Jan 11, 1988
HAEMONETICS CELL SAVER MINI SAVER AUTO. BLOOD SYS.
K872895 · CAL
Haemonetics Corp.
Anesthesiology · 172d
Cleared Jan 11, 1988
IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530
K872942 · LKQ
Clinical Sciences, Inc.
Microbiology · 168d
Cleared Jan 11, 1988
SUPERVISOR SUN GOGGLES(TM)
K873405 · HQY
Eye Communications, Inc.
Ophthalmic · 139d
Cleared Jan 11, 1988
QBC BLOOD BANK SYSTEM
K874147 · GKZ
Bd Becton Dickinson Vacutainer...
Hematology · 90d
Cleared Jan 11, 1988
IVT SOUTHEAST ALLERGY SCREEN
K874168 · DHB
In Vitro Technologies, Inc.
Immunology · 90d
Cleared Jan 11, 1988
IVT NORTHEAST ALLERGY SCREEN
K874169 · DHB
In Vitro Technologies, Inc.
Immunology · 90d
Cleared Jan 11, 1988
THREE CHAR. TEST-CHILD & WORTH 4 DOT TEST NEARPT.
K874250 · HLP
Richmond Products, Inc.
Ophthalmic · 84d