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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
78961–78984 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 19, 2001
RADIAL HEAD IMPLANT
K011819 · KWI
Avanta Orthopaedics, Inc.
Orthopedic · 8d
Cleared Jun 19, 2001
INTERLINK THREADED LOCK CANNULA
K011858 · FPA
Bd
General Hospital · 5d
Cleared Jun 18, 2001
PRECISION XTRA BLOOD GLUCOSE TEST STRIP WITH TRUEMEASURE TECHNOLOGY
K010553 · NBW
Abbott Laboratories
Chemistry · 112d
Cleared Jun 18, 2001
LAP DISC 120 X 120, MODEL LD111, LAP DISC 120 X 100, MODEL LD112, LAP DISC 70...
K010870 · GCJ
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 87d
Cleared Jun 18, 2001
RETROGRADE CARDIOPLEGIA CANNULA, MANUAL-INFLATING, WITH MALLEABLE OR GUIDWIRE...
K010974 · DWF
Sorin Group Italia S.R.L.
Cardiovascular · 77d
Cleared Jun 18, 2001
FLOWABLE COMPOSITE/ ECUFLOW/ LUXAFLOW
K011211 · EBF
Dmg USA, Inc.
Dental · 60d
Cleared Jun 18, 2001
IBD-CHEK
K011396 · DEG
Techlab, Inc.
Immunology · 42d
Cleared Jun 18, 2001
CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND TDM CONTROL...
K011548 · JJY
Medical Analysis Systems, Inc.
Chemistry · 31d
Cleared Jun 18, 2001
EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229
K011620 · LAN
Syva Co., Dade Behring, Inc.
Toxicology · 24d
Cleared Jun 15, 2001
NEURO-TRAIN III (3)
K003433 · IPF
Sterne Equipment Co., Ltd.
Physical Medicine · 221d
Cleared Jun 15, 2001
ACTI-ICP MONITORING SYSTEM
K003905 · GWM
Innerspace, Inc.
Neurology · 178d
Cleared Jun 15, 2001
CORDIS M3 PTA DILATATION CATHETER
K003920 · DQY
Cordis Corp.
Cardiovascular · 178d
Cleared Jun 15, 2001
NTERO NOMAD SYSTEM
K010815 · GEI
Ntero Surgical, Inc.
General & Plastic Surgery · 88d
Cleared Jun 15, 2001
MX8000 V5.0 CT SYSTEM
K010817 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 88d
Cleared Jun 15, 2001
HANDMASTER
K010837 · GZI
Neuromusclar Electrical Stimulation...
Neurology · 87d
Cleared Jun 15, 2001
MALE NATURAL RUBBER LATEX CONDOM
K010919 · HIS
Innolatex Sdn. Bhd
Obstetrics & Gynecology · 80d
Cleared Jun 15, 2001
CRYOCARE CARDIAC SURGICAL SYSTEM
K011040 · OCL
Endocare, Inc.
Cardiovascular · 71d
Cleared Jun 15, 2001
OMNIPORT HAND AND INSTRUMENT ACCESS DEVICE
K011183 · GCJ
Advanced Surgical Concepts (Asc)
General & Plastic Surgery · 58d
Cleared Jun 15, 2001
MODIFICATION TO THE BOLD SCREW
K011262 · HWC
New Deal, S.A.
Orthopedic · 51d
Cleared Jun 15, 2001
EXCEL FRACTURE CEMENTED HIP STEM
K011367 · JDI
DePuy Orthopaedics, Inc.
Orthopedic · 42d
Cleared Jun 15, 2001
OMNILINK .035 BILIARY STENT SYSTEM
K011506 · FGE
Guidant Corp.
Gastroenterology & Urology · 30d
Cleared Jun 15, 2001
EEG MIS MONITOR MODEL # A-2000
K011534 · OLW
Aspect Medical Systems, Inc.
Neurology · 28d
Cleared Jun 15, 2001
QUANTITATIVE GATED SPECT (QGS), QUANTITATIVE PERFUSION SPECT (QPS)
K011572 · KPS
Digirad Corp.
Radiology · 25d
Cleared Jun 15, 2001
OSTEO IC FEMORAL AND TIBIAL NAILS AND OSTEO RETROGRADE/ANTEGRADE FEMORAL...
K011622 · HSB
Howmedica Osteonics Corp.
Orthopedic · 21d