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
77665–77688 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Oct 25, 2001
MONOJECT SAFETY NEEDLE
K012736 · FMI
Tyco Healthcare
General Hospital · 70d
Cleared Oct 25, 2001
MACROPORE ENT RECONSTRUCTION FILM
K012769 · NHB
Macropore Biosurgery, Inc.
Ear, Nose, Throat · 69d
Cleared Oct 25, 2001
WINNER CM4 COMBINATION UNIT
K012848 · GZJ
Rich-Mar Corp.
Neurology · 63d
Cleared Oct 25, 2001
COLLATEK SHEET
K012995 · MGP
Biocore Medical Technologies, Inc.
General & Plastic Surgery · 49d
Cleared Oct 25, 2001
COLLATEK FOAM
K012997 · MGP
Biocore Medical Technologies, Inc.
General & Plastic Surgery · 49d
Cleared Oct 25, 2001
CERCON BASE
K013230 · EIH
Degussa - Ney Dental, Inc.
Dental · 28d
Cleared Oct 25, 2001
ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY
K013272 · KLS
Bayer Corp.
Chemistry · 24d
Cleared Oct 24, 2001
EMS JUMPER II DUAL CHANNEL NEUROMUSCULAR STIMULATOR SYSTEM, MODEL E-188
K000741 · IPF
138 Medical Supplies, Inc.
Physical Medicine · 596d