FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
79321–79344 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Mar 19, 2001
RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20
K010052 · MQM
Respironics, Inc.
Chemistry · 70d
Cleared Mar 19, 2001
XLTEK REAL PATIENT EVOKED POTENTIAL HEADBOX, MODEL EP-16-RP
K010087 · GWF
Excel Tech. , Ltd.
Neurology · 67d
Cleared Mar 19, 2001
TRIFIX SPINAL FIXATION SYSTEM
K010535 · MNH
Endius, Inc.
Orthopedic · 24d
Cleared Mar 19, 2001
MICROWAVAE DELIVERY SYSTEM #MW2000
K010589 · MWY
Mw Medical, Inc.
General & Plastic Surgery · 20d
Cleared Mar 18, 2001
4 PORT, 4 WAY STOPCOCK
K010217 · FMG
George Loo, MD
General Hospital · 53d
Cleared Mar 18, 2001
NPAC MULTI-USE THERMOMETER, MODEL TD400
K010224 · FLL
Norm Pacific Automation Corp.
General Hospital · 53d
Cleared Mar 16, 2001
COOK PRESSURE MONITORING CATHETER
K002254 · DQO
Cook, Inc.
Cardiovascular · 234d
Cleared Mar 16, 2001
ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA
K002706 · DAP
Roche Diagnostics Corp.
Hematology · 198d
Cleared Mar 16, 2001
E MOTION WHEELCHAIR DRIVE SYSTEM (POWER-ASSIST FOR MANUAL WHEELCHAIRS)
K003449 · ITI
Ulrich Alber GmbH & Co.
Physical Medicine · 129d