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
169009–169032 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 28, 1979
MULTECON BLOOD GAS CONTROL
K790813 · JJS
Ortho Diagnostics, Inc.
Chemistry · 62d
Cleared Jun 28, 1979
UV URIC ACID DETERMINATION
K790834 · CDO
The Dow Chemical Co.
Chemistry · 59d
Cleared Jun 28, 1979
THYROID CONTROL SERA CODE QAS.101
K790840 · JJY
Amersham Corp.
Chemistry · 57d
Cleared Jun 28, 1979
BIOVATION DIGITAL URINOMETER
K790862 · JRE
Biovation, Inc.
Chemistry · 52d
Cleared Jun 28, 1979
LANCER HDL SEPARATION KIT
K790865 · LBR
Sherwood Medical Co.
Chemistry · 52d
Cleared Jun 28, 1979
HPL RIA KIT
K790919 · JMF
Technia Diagnostics , Ltd.
Chemistry · 45d
Cleared Jun 28, 1979
CITRATE AGAR GEL AND BUFFER SET
K790944 · JBD
Corning Medical & Scientific
Hematology · 41d
Cleared Jun 28, 1979
AUTO ENZYMATIC CHOLESTEROL
K790947 · CHH
Macomb Chemical Co.
Chemistry · 41d
Cleared Jun 28, 1979
120 WELL HISTO-PLATE
K790958 · KIZ
Dynatech Laboratories, Inc.
Pathology · 37d
Cleared Jun 28, 1979
LIQUID SCINTILLATION COUNTER
K790961 · JJJ
Nuclear Ent. , Ltd.
Chemistry · 37d
Cleared Jun 28, 1979
REAGENT STRIPS FOR URINALYSIS
K790965 · CDM
Miles Laboratories, Inc.
Chemistry · 37d
Cleared Jun 28, 1979
RF CONTROLS
K790986 · DMR
Wampole Laboratories
Immunology · 34d
Cleared Jun 28, 1979
PROTHROMBIN FREE BEEF PLASMA (PFB)
K791023 · GJS
Pacific Hemostasis
Hematology · 29d
Cleared Jun 28, 1979
SYNALON ROLLER BOTTLE
K791049 · KJC
Dynatech Laboratories, Inc.
Pathology · 22d
Cleared Jun 28, 1979
LEECO GLYCO-HEMOGLOBIN DIAGNOSTIC KIT
K791103 · LCP
Leeco Diagnostics, Inc.
Hematology · 15d
Cleared Jun 28, 1979
LOW IONIC STRENGTH SOLUTION (LISS)
K791113 · KSG
Hyland Therapeutic Div., Travenol...
Hematology · 13d
Cleared Jun 28, 1979
LYOPHILIZED G-HB QUIK COLUMN CONTROL
K791135 · LCP
Helena Laboratories
Hematology · 10d
Cleared Jun 27, 1979
WEISS EMERGENCY AIRWAY SYSTEM
K790650 · BWC
Intl. Medical Devices , Ltd.
Anesthesiology · 85d
Cleared Jun 27, 1979
PULSE GENERATOR MODEL 629
K790670 · DXY
Elema-Schonander, Inc.
Cardiovascular · 82d
Cleared Jun 27, 1979
DELTA PUMP
K790814 · FRN
Spiess Design, Inc.
General Hospital · 61d
Cleared Jun 27, 1979
REPGREEN ULTRAFILTRATION MONITOR
K790824 · FIL
Cyberex Corp.
Gastroenterology & Urology · 57d
Cleared Jun 27, 1979
TG 2, TRI-GARD PRESSURE MONITOR
K790841 · KOC
Sorensen Research
Gastroenterology & Urology · 56d
Cleared Jun 27, 1979
TRACH T WITH ONE-WAY VALVES
K790888 · BZA
Airlife, Inc.
Anesthesiology · 51d
Cleared Jun 27, 1979
TEMPO2-I DISPOSABLE THERMOMETERS
K790890 · FQZ
Airlife, Inc.
General Hospital · 51d