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
79825–79848 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 20, 2001
LACTOSORB 5.0 MM WASHER
K001581 · HWC
Biomet, Inc.
Orthopedic · 302d
Cleared Mar 20, 2001
FS ACTIVATOR III
K003185 · LXM
Activator Methods International, Ltd.
Physical Medicine · 160d
Cleared Mar 20, 2001
MODIFICATION TO ITI DENTAL IMPLANT SYSTEM
K003271 · DZE
Institut Straumann AG
Dental · 153d
Cleared Mar 20, 2001
ESCREEN SYSTEM
K003352 · LAF
Escreen, Inc.
Toxicology · 145d
Cleared Mar 20, 2001
APEX MODULAR ZIRCONIA FEMORAL HEAD
K003923 · LZO
Apex Surgical, LLC
Orthopedic · 90d
Cleared Mar 20, 2001
NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM
K010031 · KTB
Wescor, Inc.
Physical Medicine · 76d
Cleared Mar 20, 2001
MODIFICATION TO TRIDENT ALL POLY CUP
K010310 · JDI
Howmedica Osteonics Corp.
Orthopedic · 47d
Cleared Mar 20, 2001
ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM
K010482 · JOP
Echocath, Inc.
Cardiovascular · 28d
Cleared Mar 20, 2001
WRISTWATCH BLOOD PRESSURE MONITOR A46
K010498 · DXN
Rossmax Internationl , Ltd.
Cardiovascular · 27d
Cleared Mar 20, 2001
PORTRAIT FEMORAL COMPONENT
K010560 · LZO
Biomet, Inc.
Orthopedic · 22d
Cleared Mar 20, 2001
MODIFICATION TO LAP TOP VENTILATOR (LTV)
K010608 · CBK
Pulmonetic Systems, Inc.
Anesthesiology · 19d
Cleared Mar 20, 2001
SIEMENS MEDICAL INFORMATION BUS (MIB II) PROTOCOL CONVERTER
K010640 · DRQ
Siemens Medical Solutions USA, Inc.
Cardiovascular · 15d
Cleared Mar 20, 2001
PLEURX PLEURAL CATHETER AND DRAINAGE KITS
K010642 · DWM
Denver Biomedicals, Inc.
Anesthesiology · 15d
Cleared Mar 20, 2001
EXHALE DOPPLER SYSTEM
K010649 · IYN
Broncus Technologies, Inc.
Radiology · 15d
Cleared Mar 19, 2001
WRISTWATCH BPM BLOOD PRESSURE MONITOR, MODEL KP-6120
K002665 · DXN
K-Jump Health Co., Ltd.
Cardiovascular · 206d
Cleared Mar 19, 2001
NEOLYNX SCREENING APPLICATION MANAGER
K003584 · JNB
Micromass, Inc.
Chemistry · 119d
Cleared Mar 19, 2001
C1-INHIBITOR MICROTITER ASSAY DEVICE
K003747 · DBA
Baxter Healthcare Corp
Immunology · 105d
Cleared Mar 19, 2001
ACCU-CHEK INFORM METER
K003846 · LFR
Roche Diagnostics Corp.
Chemistry · 97d
Cleared Mar 19, 2001
NEXGEN COMPLETE KNEE SOLUTION CROSS-LINKED POLYETHYLENE CRUCIATE RETAINING...
K003910 · JWH
Zimmer, Inc.
Orthopedic · 90d
Cleared Mar 19, 2001
BAUMER CEMENTED HIP PROSTHESIS
K003975 · JDI
Baumer, S.A
Orthopedic · 87d
Cleared Mar 19, 2001
BAUMER MULLER HIP PROSTHESIS
K003976 · JDI
Baumer, S.A
Orthopedic · 87d
Cleared Mar 19, 2001
MEDTRADE PRODUCTS SILICON SCAR MANAGEMENT PAD
K003979 · MDA
Medtrade Products , Ltd.
General & Plastic Surgery · 87d
Cleared Mar 19, 2001
SUPER REVO SUTURE ANCHOR
K003984 · MAI
Linvatec Corp.
Orthopedic · 83d
Cleared Mar 19, 2001
STERILE SUBDERMAL NEEDLE ELECTRODES
K010019 · GXZ
Nicolet Biomedical, Inc.
Neurology · 76d