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

Filters: Cleared only ×
176,076 results
61417–61440 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 13, 2006
PRE' VAGINAL LUBRICANT
K051436 · PEB
Ingfertlity, LLC
Obstetrics & Gynecology · 499d
Cleared Oct 13, 2006
COLOPLAST OSTOMY ROD, MODEL 12814
K052229 · EZP
Coloplast Corp.
Gastroenterology & Urology · 423d
Cleared Oct 13, 2006
NET-2000 MICROCURRENT STIMULATOR
K060158 · QJQ
Auri-Stem Medical, Inc.
Neurology · 266d
Cleared Oct 13, 2006
MEDRELIEF ST SERIES, MODELS RT-50, ST-100, ST 150, ST-200, ST-300
K060669 · GZJ
Healthonics, Inc.
Neurology · 213d
Cleared Oct 13, 2006
HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR
K061070 · DRC
Hansen Medical, Inc.
Cardiovascular · 179d
Cleared Oct 13, 2006
APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM
K061413 · MKZ
Gen-Probe, Inc.
Microbiology · 144d
Cleared Oct 13, 2006
STELLARTECH 100 COAGULATION SYSTEM
K061544 · GEI
Stellartech Research Corp.
General & Plastic Surgery · 130d
Cleared Oct 13, 2006
WALLACE ARTIFICIAL INSEMINATION CATHETER
K061679 · LKF
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 120d
Cleared Oct 13, 2006
VERESS CANNULA AND MODULAR VERESS CANNULA
K062097 · HET
PAJUNK GmbH Medizintechnologie
Obstetrics & Gynecology · 81d
Cleared Oct 13, 2006
CONFORM
K062157 · EBF
Apex Dental Materials, Inc.
Dental · 77d
Cleared Oct 13, 2006
DEPUY LPS PROXIMAL TIBIAL COMPONENT
K062301 · KRO
DePuy Orthopaedics, Inc.
Orthopedic · 66d
Cleared Oct 13, 2006
HEALOS FX BONE GRAFT SUBSTITUTE AND GRAFT MIXING AND DELIVERY SYSTEM
K062495 · MQV
Depuy Spine, Inc.
Orthopedic · 49d
Cleared Oct 13, 2006
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K062681 · JWY
Trek Diagnostic Systems, Ltd.
Microbiology · 35d
Cleared Oct 13, 2006
SURGISIS, SURGISIS ES
K062696 · FTM
Cook Biotech, Inc.
General & Plastic Surgery · 32d
Cleared Oct 13, 2006
SIS HERNIA REPAIR DEVICE, SURGISIS GOLD HERNIA REPAIR GRAFT
K062697 · FTL
Cook Biotech, Inc.
General & Plastic Surgery · 32d
Cleared Oct 13, 2006
CR 85-X
K062742 · MQB
Agfa Corporation
Radiology · 29d
Cleared Oct 13, 2006
CTL-63 AND CTL-128 SPINE ARRAY COILS
K062767 · MOS
Invivo Corporation
Radiology · 28d
Cleared Oct 13, 2006
NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED FLEX FIXED BEARING...
K062768 · JWH
Zimmer, Inc.
Orthopedic · 28d
Cleared Oct 13, 2006
MICROSCAN MICROSTREP PLUS PANEL, PENICILLIN
K062773 · LTT
Dade Behring, Inc.
Microbiology · 25d
Cleared Oct 13, 2006
MODIFICATION TO ENDO-EASE
K062805 · FED
Spirus Medical, Inc.
Gastroenterology & Urology · 24d
Cleared Oct 13, 2006
LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT
K062808 · LPS
Catch Incorporated
Chemistry · 24d
Cleared Oct 13, 2006
COLLAGEN DENTAL MEMBRANE III
K062846 · NPL
Collagen Matrix, Inc.
Dental · 21d
Cleared Oct 13, 2006
XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII
K062895 · MPA
Dutch Ophthalmic Research Center...
Ophthalmic · 16d
Cleared Oct 13, 2006
MICROSCAN MICROSTREP PLUS PANEL TETRACYCLINE (0.006 TO 16 MCG/ML)
K062923 · LRG
Dade Behring, Inc.
Microbiology · 15d