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
70465–70488 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 29, 2003
DATEX OHMEDA S/5 WEB VIEWER AND S/5 POCKET VIEWER WITH L-WEB03 SOFTWARE
K033078 · MSX
Datex-Ohmeda
Cardiovascular · 30d
Cleared Oct 29, 2003
SECTRA IDS5 RADIOLOGY WORKSTATION VERSION 10.1
K033088 · LLZ
Sectra AB
Radiology · 30d
Cleared Oct 29, 2003
MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEM
K033126 · LIL
Behavioral Technology, Inc.
Gastroenterology & Urology · 29d
Cleared Oct 29, 2003
NEUROMUSCULAR ELECTRICAL STIMULATOR, MODEL EV-807P
K033140 · IPF
Everyway Medical Instruments Co.,Ltd
Physical Medicine · 29d
Cleared Oct 29, 2003
ALOKA SSD-5000 V5.0 ULTRASOUND SYSTEM
K033311 · IYN
Aloka Co., Ltd.
Radiology · 15d
Cleared Oct 29, 2003
SUPEROPEN 0.23T, MODEL NAM-P023A
K033315 · LNH
Neusoft Digital Medical Systems Co.,...
Radiology · 14d
Cleared Oct 29, 2003
PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM
K033326 · JAK
Philips Medical Systems, Inc.
Radiology · 13d
Cleared Oct 28, 2003
ORTRAUTEK ORTHOGNATHIC SYSTEM
K031989 · JEY
Tekka
Dental · 123d
Cleared Oct 28, 2003
NXSTAGE SYSTEM ONE WITH CARTRIDGE EXPRESS
K032356 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 90d
Cleared Oct 28, 2003
MEDTRONIC MINIMED PARADIGM COUNTACH INFUSION SET, MODEL MMT 310
K032484 · FPA
Medtronic Minimed
General Hospital · 77d
Cleared Oct 28, 2003
MEDTRONIC MINIMED COUNTACH INFUSION SET, MODEL 313
K032485 · FPA
Medtronic Minimed
General Hospital · 77d
Cleared Oct 28, 2003
KAVO EVEREST ZH-BLANK
K033221 · EIH
Kavo America Corporation
Dental · 25d
Cleared Oct 28, 2003
BUTLER NUCARE ROOT CONDITIONER WITH NOVAMIN
K033295 · LBH
Novamin Technology, Inc.
Dental · 14d
Cleared Oct 27, 2003
PERFADEX SOLUTION FOR LUNG PRESERVATION
K022730 · MSB
Vitrolife AB
Gastroenterology & Urology · 437d
Cleared Oct 27, 2003
EMBLA N7000
K024322 · MNR
Medcare Flaga
Anesthesiology · 305d
Cleared Oct 27, 2003
FLUID SAMPLE RETRIEVAL SYSTEM
K030394 · JKA
Biomed Personal Metabolic and...
Chemistry · 264d
Cleared Oct 27, 2003
SWISS MASTER LIGHT
K032099 · EBZ
(Ems Sa) Electro Medical Systems
Dental · 111d
Cleared Oct 27, 2003
SMARTMONITOR 2 PROFESSIONAL SERIES (PS)
K032403 · NPF
Respironics, Inc.
Anesthesiology · 84d
Cleared Oct 27, 2003
VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER
K033108 · EWO
Vivosonic, Inc.
Ear, Nose, Throat · 27d
Cleared Oct 27, 2003
CENTRA VIEW DEVICE LINK SYSTEM
K033283 · MWI
Icu Datasystems, Inc.
Cardiovascular · 13d
Cleared Oct 24, 2003
AVITA TS8/TS9 SERIES IR EAR/FOREHEAD THERMOMETER
K031503 · FLL
Avita Corporation
General Hospital · 164d
Cleared Oct 24, 2003
SAFESKIN* BLUE ZONE POWDER-FREE VINYL EXAM GLOVE
K031750 · LYZ
Kimberly-Clark Corp.
General Hospital · 141d
Cleared Oct 24, 2003
BRAUN THERMOSCAN PRO 4000 SERIES (PROFESSIONAL USE ENVIRONMENT)
K031928 · FLL
Braun GmbH
General Hospital · 123d
Cleared Oct 24, 2003
NUVASIVE NEUROVISION JJB SYSTEM
K032083 · ETN
Nuvasive, Inc.
Ear, Nose, Throat · 109d