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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
77137–77160 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 29, 2001
MICROMEDICS FIBRIJET AEROSOL APPLICATOR
K012868 · FMF
Micromedics, Inc.
General Hospital · 63d
Cleared Oct 29, 2001
FUJI VII CAPSULE
K013198 · EMA
GC America, Inc.
Dental · 34d
Cleared Oct 29, 2001
XANTALGIN CRONO
K013336 · ELW
Cavex Holland BV
Dental · 20d
Cleared Oct 29, 2001
BELLEGLASS HP OPAQUE 2
K013375 · EBF
Kerr Dental Materials Center
Dental · 18d
Cleared Oct 29, 2001
CRANIAL HELMET
K013458 · MVA
Children'S Hospital
Neurology · 11d
Cleared Oct 26, 2001
STOCKERT V172 SERIES VENOUS FEMORAL CANNULAE
K001509 · DWF
Cobe Cardiovascular, Inc.
Cardiovascular · 529d
Cleared Oct 26, 2001
BIOPATCH ANTIMICROBIAL DRESSING
K003229 · SEL
Integra Lifesciences Corp.
General & Plastic Surgery · 381d
Cleared Oct 26, 2001
OSTEOSET BVF KIT
K010532 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 245d
Cleared Oct 26, 2001
AGILENT ELECTRONIC STETHOSCOPE, MODELS M4532A AND M4533A
K010729 · DQD
Andromed, Inc.
Cardiovascular · 228d
Cleared Oct 26, 2001
VITALSAT PULSE OXIMETER, MODEL IC32000
K011365 · DQA
Island Critical Care Corp.
Anesthesiology · 175d
Cleared Oct 26, 2001
SUN-TENS PALM TYPE R5/COMPACT WIRELES M2 EMS SERIES
K011913 · IPF
Sun-Rain System Corp.
Physical Medicine · 129d
Cleared Oct 26, 2001
INFINITY HBA KIT, MODELS 537-A, 537-B
K012410 · LCP
Sigma Diagnostics, Inc.
Hematology · 88d
Cleared Oct 26, 2001
CONFOSCAN 2 CONFOCAL MICROSCOPE
K012416 · HJO
Nidek Technologies Srl
Ophthalmic · 88d
Cleared Oct 26, 2001
DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM
K012449 · MID
Diamedix Corp.
Immunology · 86d
Cleared Oct 26, 2001
DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEM
K012450 · MID
Diamedix Corp.
Immunology · 86d
Cleared Oct 26, 2001
GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM
K012628 · OTN
Gynecare Center
Gastroenterology & Urology · 74d
Cleared Oct 26, 2001
TOURNIQUET CUFF
K012632 · KCY
Medical Instruments Technology, Inc.
General & Plastic Surgery · 74d
Cleared Oct 26, 2001
BPTRU AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100
K012636 · DXN
Vsm Technology, Inc.
Cardiovascular · 74d
Cleared Oct 26, 2001
SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU - 45MM, MODEL RALC45
K012809 · GDW
Power Medical Interventions, Inc.
General & Plastic Surgery · 65d
Cleared Oct 26, 2001
NU-SPEC D
K012859 · HIB
Sol Weiss MD, Inc.
Obstetrics & Gynecology · 63d
Cleared Oct 26, 2001
GORE-TEX VASCULAR GRAFT
K013250 · DSY
W.L. Gore & Associates, Inc.
Cardiovascular · 28d
Cleared Oct 26, 2001
MODIFICATION TO: ERBE APC CONNECTOR HOSE AND PROBES, MODELS 20132-158,...
K013348 · GEI
Erbe USA, Inc.
General & Plastic Surgery · 17d
Cleared Oct 26, 2001
SPARC SLING SYSTEM
K013355 · OTN
American Medical Systems, Inc.
Gastroenterology & Urology · 16d
Cleared Oct 26, 2001
ADVANCED LUNG ANALYSIS-1
K013381 · JAK
General Electric Co.
Radiology · 14d