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
65281–65304 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 01, 2005
ITAG MHC TETRAMER CMV ASSAY
K051122 · GKZ
Beckman Coulter, Inc.
Hematology · 91d
Cleared Aug 01, 2005
OSTEOCURE RESORBABLE BEAD KIT
K051406 · MQV
Nexa Orthopedics, Inc.
Orthopedic · 62d
Cleared Aug 01, 2005
LIPOPROTEIN FOR MULTIPLE ANALYTES
K051619 · JIX
Bayer Healthcare, LLC
Chemistry · 45d
Cleared Aug 01, 2005
POWDER-FREE SYNTHETIC VINYL EXAM GLOVES WITH VITAMIN E COATING
K051683 · LYZ
Shen Wei (Usa), Inc.
General Hospital · 39d
Cleared Aug 01, 2005
MAXPLUS TRU-SWAB POSITIVE DISPLACEMENT CONNECTOR
K051939 · FPA
Medegen Medical Manufacturing System
General Hospital · 14d
Cleared Jul 29, 2005
INTRALASE FS LASER
K041893 · GEX
Intra Lase Corp.
General & Plastic Surgery · 381d
Cleared Jul 29, 2005
LENS PLUS REWETTING DROPS
K042562 · LPN
Advanced Medical Optics, Inc.
Ophthalmic · 311d
Cleared Jul 29, 2005
DYNAGRAFT II DENTAL
K043573 · NUN
Isotis Orthobiologics, Inc.
Dental · 214d
Cleared Jul 29, 2005
VARI-LASE ENDOVENOUS LASER PROCEDURE KIT
K051287 · GEX
Vascular Solutions, Inc.
General & Plastic Surgery · 72d
Cleared Jul 29, 2005
CLARIS NON-STICK BIPOLAR FORCEPS
K051429 · GEI
Guenter Bissinger Medizintechnik GmbH
General & Plastic Surgery · 58d
Cleared Jul 29, 2005
T2 ANKLE ARTHRODESIS NAIL
K051590 · HSB
Howmedica Osteonics Corp.
Orthopedic · 44d
Cleared Jul 29, 2005
HANS HERMANN LAPAROSCOPES AND ACCESSORIES
K051610 · GCJ
Hans Hermann GmbH
General & Plastic Surgery · 42d
Cleared Jul 29, 2005
LTV 1000 VENTILATOR
K051767 · CBK
Pulmonetic Systems, Inc.
Anesthesiology · 29d
Cleared Jul 28, 2005
AFT
K042125 · MQV
Musculoskeletal Transplant Foundation
Orthopedic · 356d
Cleared Jul 28, 2005
BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT
K042579 · NBT
The Binding Site
Immunology · 309d
Cleared Jul 28, 2005
QUEST DIAGNOSTICS HAIRCHECK-DT (PCP
K042726 · LCM
Quest Diagnostics, Inc.
Toxicology · 300d
Cleared Jul 28, 2005
ALLFIM IMPLANT SYSTEMS
K050635 · DZE
Cowellmedi Co., Ltd.
Dental · 119d
Cleared Jul 28, 2005
AXIOM EPS8000
K050687 · IPF
Axiom Worldwide, Inc.
Physical Medicine · 133d
Cleared Jul 28, 2005
CORONARY SINUS ACCESS KIT, MODEL KCS8F-01
K050808 · LYK
Cardio-Optics, Inc.
Cardiovascular · 120d
Cleared Jul 28, 2005
BIB PTA BALLOON CATHETER
K050857 · NVM
NuMED, Inc.
Cardiovascular · 114d
Cleared Jul 28, 2005
BOSWORTH SEAL
K051224 · EBC
Harry J. Bosworth Co.
Dental · 77d
Cleared Jul 28, 2005
MINI GHOST PTA CATHETER, MODEL 507
K051343 · DQY
NuMED, Inc.
Cardiovascular · 66d
Cleared Jul 28, 2005
VITAL SIGNS MONITOR
K051375 · DXN
Mediana Co., Ltd.
Cardiovascular · 63d
Cleared Jul 28, 2005
SPI EASY TEMPORARY CAP
K051527 · NHA
Thommen Medical AG
Dental · 50d