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
172225–172248 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 21, 1977
BIPOLAR LEADS, DISP.
K772103 · DTB
Medtronic Vascular
Cardiovascular · 14d
Cleared Nov 21, 1977
TOMOGRAPHIC SYSTEM, COMPUTERIZED
K772123 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 10d
Cleared Nov 21, 1977
TOMOGRAPHIC SCANNER, COMPUTERIZED
K772125 · JAK
Emi Medical, Inc.
Radiology · 10d
Cleared Nov 21, 1977
VEIN CLAMPS
K772137 · DXC
A&A Ent.
Cardiovascular · 7d
Cleared Nov 18, 1977
OB/GYN LASER, MODEL 920
K772023 · HHR
Photon Sources
Obstetrics & Gynecology · 28d
Cleared Nov 18, 1977
CHEST FLUID MONITOR
K772092 · DSB
Dynatech Research & Development Co.
Cardiovascular · 11d
Cleared Nov 18, 1977
IMPEDANCE RHEOGRAPH
K772093 · DQB
Dynatech Research & Development Co.
Cardiovascular · 11d
Cleared Nov 17, 1977
PUMP, BYPASS, PULSATILE, AVCO
K770937 · KFM
Avco Medical Products
Cardiovascular · 178d
Cleared Nov 17, 1977
PRESSURE TUBING
K771810 · DQO
Pharmaseal Div., Baxter Healthcare Corp.
Cardiovascular · 51d
Cleared Nov 17, 1977
MYCOPLASMA DETECTION KIT
K771867 · KPB
Bioassay Systems Research Corp.
Microbiology · 45d
Cleared Nov 17, 1977
CENTRIA INSULIN RIA
K771979 · CFP
Union Carbide Corp.
Immunology · 31d
Cleared Nov 17, 1977
GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP
K772032 · CJE
Harleco
Chemistry · 21d
Cleared Nov 17, 1977
GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP*
K772033 · JMK
Harleco
Chemistry · 21d
Cleared Nov 17, 1977
GEMSAEC APPLI. FOR ULTRAZYME PLUS CK-1
K772034
Harleco
Chemistry · 21d
Cleared Nov 17, 1977
GEMSAEC APPLI. FOR ULTRAZYME PLUS Y-AMYL
K772035 · JFJ
Harleco
Chemistry · 21d
Cleared Nov 17, 1977
IN VITRO T3 RIA TEST
K772108 · CDP
Clinical Assays, Inc.
Immunology · 10d
Cleared Nov 17, 1977
NON-FERMENTER SYSTEM
K772112 · JSW
Corning Medical & Scientific
Microbiology · 10d
Cleared Nov 17, 1977
ASPIRATOR & PROBE, CYTOLOGY, ENDOMET.
K772121 · HHK
Smithkline Diagnostics, Inc.
Obstetrics & Gynecology · 7d
Cleared Nov 17, 1977
T3 RIA KIT
K772122 · CDP
Antibodies, Inc.
Immunology · 7d
Cleared Nov 16, 1977
PEDIATRICS GOWN
K771929 · FYB
Convertors
General Hospital · 33d
Cleared Nov 16, 1977
IN-LINE BURETTE SET
K772036 · FPA
Abbott Laboratories
Hematology · 20d
Cleared Nov 16, 1977
URINARY DRAINAGE BAG 2D9017
K772113 · EYZ
Travenol Laboratories, S.A.
Gastroenterology & Urology · 9d
Cleared Nov 16, 1977
LENSES, EYEGLASS, SAFETY
K772124 · HQG
Techsight Corp.
Ophthalmic · 5d
Cleared Nov 15, 1977
PROXIMATE DISP. SKIN STAPLER
K771619 · GAG
Ethicon, Inc.
General & Plastic Surgery · 83d