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
91417–91440 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 05, 1997
POWERTREK INSTRUMENTS
K972057 · ERL
Medtrek Corp.
Ear, Nose, Throat · 156d
Cleared Nov 05, 1997
POWDER-FREE HYPOALLERGENIC NITRILE EXAMINATION GLOVES
K972090 · LZA
Shen Wei (Usa), Inc.
General Hospital · 154d
Cleared Nov 05, 1997
SERAQUEST VZV IGG
K972295 · LFY
Quest Intl., Inc.
Microbiology · 139d
Cleared Nov 05, 1997
VITALMIX PLUS EMPTY I.V. CONTAINER
K972464 · KPE
Pacific Device, Inc.
General Hospital · 127d
Cleared Nov 05, 1997
MDC SAFE STEP SAFETY BLOOD COLLECTION NEEDLE SYSTEM
K973012 · FMI
MDC Research , Ltd.
General Hospital · 84d
Cleared Nov 05, 1997
L7 TRANSDUCER USED ON ASPEN MODEL ULTRASOUND SYSTEM
K973079 · ITX
Acuson Corp.
Radiology · 79d
Cleared Nov 05, 1997
DIGITIZER DIRECTOR: IMAGE COMPRESSION MODULE (HO4059-REV 2.0)
K973081 · LLZ
Howtek, Inc.
Radiology · 79d
Cleared Nov 05, 1997
ORATEC INTERVENTIONS MODEL ORASTAT MONOPOLAR CAUTERY DEVICE
K973158 · GEI
Oratec Interventions, Inc.
General & Plastic Surgery · 75d
Cleared Nov 05, 1997
PASCO MIC AND MIC/ID PANELS
K973695 · JWY
Pasco Laboratories, Inc.
Microbiology · 40d
Cleared Nov 04, 1997
PARATREND 7 INTRAVASCULAR BLOOD GAS MONITORING SYSTEM
K953893 · CCC
Biomedical Sensors, Inc.
Anesthesiology · 810d
Cleared Nov 04, 1997
TRINITY DVT SYSTEM
K963957 · JOW
Delphi Consulting Group
Cardiovascular · 398d
Cleared Nov 04, 1997
AXSYM CA 125
K964020 · LTK
Abbott Laboratories
Immunology · 393d
Cleared Nov 04, 1997
IMX CA 125
K964185 · LTK
Abbott Diagnostics
Immunology · 379d
Cleared Nov 04, 1997
THERAPIK
K964397 · ILY
The Jenex Corporation
Physical Medicine · 365d
Cleared Nov 04, 1997
SMARTVAC SMOKE EVACUATION SYSTEM
K970352 · FYD
Isomedix Operations, Inc.
General Hospital · 278d
Cleared Nov 04, 1997
HYDROCHECK MICRO FILTER
K970488 · HGX
White River Concepts
Obstetrics & Gynecology · 267d
Cleared Nov 04, 1997
PATHFINDER 3MM MAPPING MICROCATHETER (01-082001)
K970853 · DRF
Cardima, Inc.
Cardiovascular · 242d
Cleared Nov 04, 1997
VISTA EYESHOWER
K971134 · LXQ
John Branch
Anesthesiology · 221d
Cleared Nov 04, 1997
MUMPS IGG ELISA TESTY
K971857 · LJY
Gull Laboratories, Inc.
Microbiology · 168d
Cleared Nov 04, 1997
TRANSIT/RAPIDTRANSIT/SPEEDSTER/PROWLER INFUSION CATHETER
K972518 · KRA
Cordis Neurovascular, Inc.
Cardiovascular · 120d
Cleared Nov 04, 1997
CONTROL SYRINGE
K972655 · IZI
Medical Specialties Intl., Inc.
Radiology · 112d
Cleared Nov 04, 1997
IL TEST D-DIMER
K972696 · DAP
Instrumentation Laboratory CO
Hematology · 109d
Cleared Nov 04, 1997
IMATRON ULTRA ACCESS WORKSTATION WITH CARDIAC SOFTWARE EXTENSIONS
K972903 · JAK
Imatron, Inc.
Radiology · 90d
Cleared Nov 04, 1997
STELKAST BIPOLAR SYSTEM
K972961 · JDI
Stelkast Company
Orthopedic · 85d