Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
169849–169872 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 03, 1979
STIMULATOR, ELECTRICAL NERVE
K791158 · GZJ
Electreat, Inc.
Neurology · 12d
Cleared Jul 03, 1979
TEGTMEIER MAMMOMETER
K791221
Aztec Medical Products, Inc.
General & Plastic Surgery
Cleared Jun 28, 1979
ULTRA-FREE
K790445 · JRL
Millipore Corp.
Toxicology · 115d
Cleared Jun 28, 1979
DIMENSIONALL ROTATOR
K790753 · JRQ
American Hospital Supply Corp.
Immunology · 72d
Cleared Jun 28, 1979
SYRINGE TONOMETER
K790803
Medicor USA , Ltd.
Chemistry · 64d
Cleared Jun 28, 1979
COULTER ACCU-ZYME IIY-GT REAGENT KIT
K790812 · JPZ
Coulter Electronics, Inc.
Chemistry · 63d
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