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
157585–157608 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 28, 1983
COUNTWAY SYS. SOILED SPONGES-BLOOD LOS
K830273 · FQA
Ritmed, Inc.
General Hospital · 34d
Cleared Feb 28, 1983
LITHIUM DILUENT
K830283 · JIS
Shaban Mfg. Co.
Chemistry · 33d
Cleared Feb 28, 1983
ULTRA ZYME PLUS GAMMA GT #65055 & 56
K830308 · JQB
Emd Chemicals, Inc.
Chemistry · 28d
Cleared Feb 28, 1983
ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDASE
K830309 · CHH
Emd Chemicals, Inc.
Chemistry · 28d
Cleared Feb 28, 1983
LYSOSTAPHIN REAGENT SET
K830323 · JTO
Remel Co.
Microbiology · 28d
Cleared Feb 28, 1983
NEGATIVE PRESSURE ARTERIAL BLOOD LINE
K830326 · KDC
Erika, Inc.
General & Plastic Surgery · 27d
Cleared Feb 28, 1983
POLYETHYLENE MONITORING CONNECTORS
K830420 · DQO
Vertex Medical Corp.
Cardiovascular · 20d
Cleared Feb 28, 1983
LIFELINE UNIPOLAR J-LEAD #483-05
K830463 · DTB
Intermedics, Inc.
Cardiovascular · 10d
Cleared Feb 25, 1983
INHALANT PROFILE-ALLERGEN-SPECIFIC IGE
K823593 · DHB
Mast Immunosystems
Immunology · 81d
Cleared Feb 25, 1983
TANDEM-E -FER IMMUNOENZYMETRIC KIT
K823871 · DBF
Hybritech, Inc.
Chemistry · 64d
Cleared Feb 25, 1983
ALKALINE PHOSPHATES ISOENZYME SUBSTRATE
K830118 · CIN
Corning Medical & Scientific
Chemistry · 45d
Cleared Feb 25, 1983
TRIGLYCERIDE DIAGNOSTIC KIT
K830288 · CDT
Sclavo, Inc.
Chemistry · 29d
Cleared Feb 25, 1983
STRATUS FLUOROMETRIC ENZYME IMMUN0-
K830301 · JJE
American Hospital Supply Corp.
Chemistry · 28d
Cleared Feb 25, 1983
SECURA SET VOLUME LIMITING SET
K830448 · FPA
Diatek, Inc.
General Hospital · 10d
Cleared Feb 24, 1983
MULTI-PRONG FETAL SCALP ELECTRODE
K822584 · HGP
Kontron Instruments, Inc.
Obstetrics & Gynecology · 182d
Cleared Feb 24, 1983
AO DOCUSTAR(MMIRO) FUNDUS CAMERA
K822991 · HKI
Warner-Lambert Co.
Ophthalmic · 135d
Cleared Feb 24, 1983
NOSITE UV INTERIM SPECTACLES
K823825 · HQG
Patton, Boggs & Blow
Ophthalmic · 66d
Cleared Feb 24, 1983
COMPUTERIZED SPIROMETRY SYSTEM
K823922 · BZK
Ohio Medical Products
Anesthesiology · 58d
Cleared Feb 24, 1983
SEMINAL COLLECTION DEVICE
K823937 · HIS
Health Development Corp.
Obstetrics & Gynecology · 57d
Cleared Feb 24, 1983
NON-STERILE PERITONEAL ACCESS CATHET-
K830257 · FKX
Evermed, Inc.
Microbiology · 30d
Cleared Feb 24, 1983
FREEMAN/SAMUELSON TOTAL KNEE
K830408 · MBV
Depuy, Inc.
Orthopedic · 17d
Cleared Feb 23, 1983
NON-PRESSURE AUTOCLAVE FOR STERILIZATION
K823457 · FLE
Interdent, Inc.
General Hospital · 97d
Cleared Feb 23, 1983
MODEL ICPM & ACCESSORIES
K823681 · JFC
Electromedics, Inc.
Physical Medicine · 78d
Cleared Feb 23, 1983
CENTRAL VEIN CATHERIZATION KIT
K823758 · DQO
Access Devices, Inc.
Cardiovascular · 71d