Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
78265–78288 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Oct 25, 2001
OXYGENATOR
K002632 · KPJ
Adjunctive Therapeutics, Inc.
General & Plastic Surgery · 428d
Cleared Oct 25, 2001
AUTOPULSE, MODEL 100
K011046 · DRM
Revivant Corp.
Cardiovascular · 202d
Cleared Oct 25, 2001
VENODYNE DVT ADVANTAGE PLUS
K011318 · JOW
Microtek Medical, Inc.
Cardiovascular · 177d
Cleared Oct 25, 2001
DRUGS OF ABUSE MULTI-TEST STRIP
K011952 · DKZ
Microdiagnostics, Inc.
Toxicology · 126d
Cleared Oct 25, 2001
AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE
K012141 · DRN
External Counterpulsation Lab
Cardiovascular · 107d
Cleared Oct 25, 2001
ARTHROCARE ELECTROSURGERY WANDS
K012519 · GEI
Arthrocare Corp.
General & Plastic Surgery · 80d
Cleared Oct 25, 2001
LIFE 2
K012717 · EJK
Sybron Dental Specialties, Inc.
Dental · 71d