FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
44209–44232 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 29, 2012
ACCOLADE II HIP STEM
K120578 · JDI
Howmedica Osteonics
Orthopedic · 31d
Cleared Mar 29, 2012
SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390
K120616 · MHX
Spacelabs Medical, Inc.
Cardiovascular · 29d
Cleared Mar 29, 2012
TOSHIBA 1.5T QD HEAD COIL
K120627 · MOS
Quality Electrodynamics
Radiology · 28d
Cleared Mar 29, 2012
FLASH PTA BALLOON DILATATION CATHETER-4.0X14MMX135CM
K120738 · LIT
Ostial Corporation
Cardiovascular · 17d
Cleared Mar 29, 2012
IMAGER II ANGIOGRAPHIC CATHETERS
K120893 · DQO
Boston Scientific Corp
Cardiovascular · 6d
Cleared Mar 28, 2012
SMARTPILOT VIEW MODEL MK04500
K103035 · BSZ
Draeger Medical GmbH
Anesthesiology · 532d
Cleared Mar 28, 2012
CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR...
K110587 · LFR
Bayer Healthcare, LLC
Chemistry · 393d
Cleared Mar 28, 2012
ONE PERSONAL LUBRICANT (SILICONE)
K110690 · NUC
One
Obstetrics & Gynecology · 383d
Cleared Mar 28, 2012
CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER
K110894 · LFR
Bayer Healthcare
Chemistry · 364d
Cleared Mar 28, 2012
RESIGLASS PASTE
K112307 · EMA
Shofu Dental Corporation
Dental · 230d
Cleared Mar 28, 2012
CRAG LATERAL FLOW ASSAY (LFA)
K112422 · GMD
Immuno-Mycologics, Inc.
Microbiology · 218d
Cleared Mar 28, 2012
BD RECYKLEEN SHARPS COLLECTORS
K112774 · MMK
Becton, Dickinson and Company
General Hospital · 187d
Cleared Mar 28, 2012
MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY...
K112834 · JIX
Verichem Laboratories, Inc.
Chemistry · 182d
Cleared Mar 28, 2012
JIANGSU HEALTHY WAY MECHANICAL WHEELCHAIR
K112948 · IOR
Jiangsu Healthy Way Medical Equipment...
Physical Medicine · 176d
Cleared Mar 28, 2012
JIANGSU HEALTHY WAY MECHANICL WHEELCHAIR
K112950 · IOR
Jiangsu Healthy Medical Equipment Co;Ltd
Physical Medicine · 176d
Cleared Mar 28, 2012
EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM
K113243 · LFR
Eps Bio Technology Corp.
Chemistry · 147d
Cleared Mar 28, 2012
REXIOUS HOOK FIXATION SYSTEMS
K113324 · KWP
Dio Medical Co., Ltd.
Orthopedic · 139d
Cleared Mar 28, 2012
GAL-1E BLOOD GLUCOSE MONITORING SYSTEM GAL-1E BLOOD GLUCOSE TEST STRIPS...
K113547 · CGA
Apex BioTechnology Corp.
Chemistry · 118d
Cleared Mar 28, 2012
ELLIPSE PRECICE TRAUMA NAIL SYSTEM
K113695 · HSB
Ellipse Technologies, Inc.
Orthopedic · 103d
Cleared Mar 28, 2012
FOTONA XP ND: YAG LASER SYSTEM
K113702 · PDZ
Fotona D.D.
General & Plastic Surgery · 103d
Cleared Mar 28, 2012
AQUASHIELD CO2 SYSTEM
K120123 · FEQ
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 71d
Cleared Mar 28, 2012
ZAVATION IBF SYSTEM
K120576 · MAX
Zavation, LLC
Orthopedic · 30d
Cleared Mar 28, 2012
AZUR DETACHABLE 18
K120630 · KRD
MicroVention, Inc.
Cardiovascular · 27d
Cleared Mar 27, 2012
SURGICASE GUIDE
K111558 · HAW
Materialise NV
Neurology · 298d