FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
127009–127032 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 12, 1990
QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHOD
K901453 · DFT
Isolab, Inc.
Immunology · 16d
Cleared Apr 11, 1990
ULTRASCAN(R)
K896173 · IYO
Topical Delivery Systems
Radiology · 168d
Cleared Apr 11, 1990
ACCUPROBE MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST
K896493 · LQF
Gen-Probe, Inc.
Microbiology · 149d
Cleared Apr 11, 1990
DU PONT VISTA(R) IMMUNOASSAY SYSTEM
K900245 · JJQ
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 84d
Cleared Apr 11, 1990
ENZYMUN TEST(R) TSH-S
K900277 · JLW
Boehringer Mannheim Corp.
Chemistry · 82d
Cleared Apr 11, 1990
IST-200 INTERSEGMENTAL TRACTION TABLE
K900304 · JFB
Chattanooga Group, Inc.
Physical Medicine · 80d
Cleared Apr 11, 1990
AMRESCO BUN-KINETIC REAGENTS PRODUCTS #7583
K900394 · CDQ
American Research Products Co.
Chemistry · 72d
Cleared Apr 11, 1990
AMRESCO INORGANIC PHOSPHORUS PRODUCT #4312500
K900977 · CEO
American Research Products Co.
Chemistry · 39d
Cleared Apr 11, 1990
ORTHO ABNORMAL PROTEIN C CONTROL PLASMA
K901233 · GGC
Ortho Diagnostic Systems, Inc.
Hematology · 28d
Cleared Apr 11, 1990
LYPHOCHEK URINE TOXICOLOGY CONTROL - CONFIRM
K901271 · DIF
Bio-Rad
Toxicology · 23d
Cleared Apr 10, 1990
MODIFIED DPX BONE DENSITOMETER
K890121 · KGI
Lunar
Radiology · 454d
Cleared Apr 10, 1990
ARTECH TYPE SS-HA SUBMERGED SCREW IMPLANT
K895267 · DZE
Artech Corp.
Dental · 230d
Cleared Apr 10, 1990
ARIES 30CC & 50CC INTRA-AORTIC BALLOON & CONT. SYS
K895433 · DSP
Aries Medical, Inc.
Cardiovascular · 215d
Cleared Apr 10, 1990
HYDROCEPHALUS SHUNT SYSTEM, LOW/MEDIUM/HIGH PRESS.
K895524 · JXG
Theramed, Inc.
Neurology · 210d
Cleared Apr 10, 1990
MOTIONSPECT
K895881 · LXW
Baltimore Therapeutic Equipment Co.
Gastroenterology & Urology · 187d
Cleared Apr 10, 1990
SILHOUETTE PORCELAIN
K895888 · EIH
Leach and Dillon Co., Inc.
Dental · 187d
Cleared Apr 10, 1990
SOLOSTICK (AMPLATZ DILATOR NEEDLE)
K896096 · DRE
Microvena Corp.
Cardiovascular · 172d
Cleared Apr 10, 1990
LISS BODY STIMULATOR MODEL SBL501-M
K896226 · GZJ
Medical Consultants Intl. , Ltd.
Neurology · 161d
Cleared Apr 10, 1990
UPSIZING LEAD ADAPTERS 5.0MM PEEL-AWAY ADAPTER
K896438 · DTD
Telectronics Pacing Systems, Inc.
Cardiovascular · 152d
Cleared Apr 10, 1990
PTI INTRA-ART(TM) ANSARI SAPHENOUS VEIN HOLDER
K897075 · DXC
Pioneering Technologies, Inc.
Cardiovascular · 111d
Cleared Apr 10, 1990
MODEL M1175A/M1176A WITH ST SEGMENT MONITORING
K900032 · DRT
Hewlett-Packard Co.
Cardiovascular · 98d
Cleared Apr 10, 1990
ENT-2 FLEXIBLE NASOPHARYGNO-LARYNGOSCOPES
K900176 · EOB
Machida, Inc.
Ear, Nose, Throat · 88d
Cleared Apr 10, 1990
BONCHEK-SHILEY CARDIAC JACKET W/RECIRCULATION SET
K900186 · DWJ
Shiley, Inc.
Cardiovascular · 84d
Cleared Apr 10, 1990
UMBILICAL CORD BLOOD SAMPLING KIT
K900302 · CBT
Ge Medical Systems Information...
Anesthesiology · 78d