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
76729–76752 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 31, 2002
APEX MEDICAL MINI TENS
K020032 · GZJ
Apex Medical Corp.
Neurology · 27d
Cleared Jan 31, 2002
MODIFICATION TO AUGUSTINE MEDICAL WOUND CARE SYSTEM, MODEL 68XXX
K020077 · MSA
Augustine Medical, Inc.
General & Plastic Surgery · 22d
Cleared Jan 30, 2002
SPIKED WASHER
K011583 · HTN
Synthes (Usa)
Orthopedic · 252d
Cleared Jan 30, 2002
DRG QUICKMIX
K011736 · GXP
Doctor'S Research Group, Inc.
General & Plastic Surgery · 239d
Cleared Jan 30, 2002
BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM
K012184 · KWQ
Blackstone Medical, Inc.
Orthopedic · 202d
Cleared Jan 30, 2002
LIVERPOOL RADIAL HEAD REPLACEMENT DEVICE
K012551 · KWI
Biomet, Inc.
Orthopedic · 176d
Cleared Jan 30, 2002
BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1
K012702 · JWH
Endotec, Inc.
Orthopedic · 169d
Cleared Jan 30, 2002
DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER
K012924 · CAD
Datex-Ohmeda, Inc.
Anesthesiology · 152d
Cleared Jan 30, 2002
MODEL7500 MICROCURRENT TENS DEVICE, MCT-F5, MCT-F50, MCT-F500
K013167 · GZJ
Newcare Products, LLC
Neurology · 131d
Cleared Jan 30, 2002
ASCEND SPINAL FIXATION SYSTEM WITH THE SHADOW SPINAL SYSTEM
K013196 · KWP
Spinal Innovations, LLC
Orthopedic · 127d
Cleared Jan 30, 2002
LTF-240 PLEURAVIDEOSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENTS
K013617 · GCJ
Olympus Optical Co., Ltd.
General & Plastic Surgery · 86d
Cleared Jan 30, 2002
IDENT-A100 INTRAORAL VIDEO CAMERA
K013690 · EIA
Confident Technology, Inc.
Dental · 84d
Cleared Jan 30, 2002
MEDITRON II THESTERTHOSCOPE SYSTEM
K013725 · DQD
Meditron AS
Cardiovascular · 82d
Cleared Jan 30, 2002
COMPAS AS (COMPUTERIZED PULMONARY ANALYSIS SYSTEM)
K013752 · BZG
Morgan Scientific, Inc.
Anesthesiology · 78d
Cleared Jan 30, 2002
SLEEPBITE
K013808 · LRK
Dental Imagineers, LLC
Dental · 76d
Cleared Jan 30, 2002
FINN CHAMBER (R)
K013820 · KXF
Epitest Ltd. OY
General Hospital · 75d
Cleared Jan 30, 2002
ACRY PLUS, ACRY LUX, ACRY LUX V, ACRY ROCK, ACRY ROCK V AND Z-TONE PREFORMED...
K013824 · ELM
Dental Manufacturing S.P.A
Dental · 72d
Cleared Jan 30, 2002
D.SIGN 53, MODEL NA1012204
K014082 · EJS
Ivoclar Vivadent, Inc.
Dental · 50d
Cleared Jan 30, 2002
SORBA STEORRA NON-INVASIVE IMPEDANCE CARDIOGRAPH
K014299 · DSB
Sorba Medical Systems, Inc.
Cardiovascular · 30d
Cleared Jan 30, 2002
RAVEN BACTERIAL SPORE STRIPS
K020026 · FRC
Raven Biological Laboratories, Inc.
General Hospital · 26d
Cleared Jan 30, 2002
3-PIECE PROXIMAL HUMERAL REPLACEMENT SYSTEM
K020045 · KWT
Biomet Orthopedics, Inc.
Orthopedic · 23d
Cleared Jan 30, 2002
PATRIOT PROTRUSIO CAGE
K020076 · JDI
Biomet Orthopedics, Inc.
Orthopedic · 21d
Cleared Jan 29, 2002
CORTISOL LIA
K010790 · CGR
Kmi Diagnostics, Inc.
Chemistry · 320d
Cleared Jan 29, 2002
SEEDNET, MODEL FP6T5, FP5T5, FP5T3
K011950 · GEH
Galil Medical , Ltd.
General & Plastic Surgery · 222d