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
87289–87312 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 09, 1998
CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3
K984277 · JJT
Medical Analysis Systems, Inc.
Chemistry · 9d
Cleared Dec 08, 1998
CRX DIAMOND VALVE
K974096 · JXG
Phoenix Biomedical Corp.
Neurology · 404d
Cleared Dec 08, 1998
BTA STAT TEST PRESCRIPTION HOME USE
K974845 · MMW
Bard Diagnostic Sciences,Inc.
Immunology · 355d
Cleared Dec 08, 1998
CLINICAL ELECTRONIC THERMOMETER
K982140 · FLL
Valeo Corp.
General Hospital · 174d
Cleared Dec 08, 1998
PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM , QC MANAGER DATA MANAGER...
K982303 · CGA
Medisense, Inc.
Chemistry · 160d
Cleared Dec 08, 1998
PULSED OXYGEN CONSERVING DEVICE, POCD
K983459 · NFB
Medical Electronic Devices, Inc.
Anesthesiology · 69d
Cleared Dec 08, 1998
PRODIGY TOTAL BODY SOFTWARE
K983564 · KGI
Lunar Corp.
Radiology · 56d
Cleared Dec 08, 1998
ORCA-DX BONE DENSITOMETER
K983724 · KGI
Lunar Corp.
Radiology · 47d
Cleared Dec 08, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE EBV-EA IGG ELISA TEST SYSTEM. AN...
K983804 · LSE
Zeus Scientific, Inc.
Microbiology · 41d
Cleared Dec 08, 1998
MAXVIEW DIAGNOSTIC WORKSTATION
K984023 · LLZ
Dynamic Healthcare Technologies, Inc.
Radiology · 26d
Cleared Dec 08, 1998
ELECSYS TROPONIN T STAT TEST
K984105 · MMI
Boehringer Mannheim Corp.
Chemistry · 21d
Cleared Dec 08, 1998
MODIFICATION TO WILSON-COOK LUNG BIOPSY NEEDLE
K984157 · EOQ
Wilson-Cook Medical, Inc.
Ear, Nose, Throat · 19d
Cleared Dec 07, 1998
MICRO X RESIDUAL TEST STRIPS
K974064 · MSY
Reprocessing Products Corp
Gastroenterology & Urology · 406d
Cleared Dec 07, 1998
BROWNE GA INDICATOR FOR CIDEX PRODUCTS
K981054 · JOJ
Albert Browne , Ltd.
General Hospital · 259d
Cleared Dec 07, 1998
SILON TOPOMAT CORNEAL TOPOGRAPHY IMAGE ENHANCEMENT DEVICE
K981665 · MMQ
Bio-Medical Sciences, Inc.
Ophthalmic · 210d
Cleared Dec 07, 1998
CELL ROBOTICS' LASETTE
K981746 · GEX
Cell Robotics, Inc.
General & Plastic Surgery · 203d
Cleared Dec 07, 1998
POWDER FREE (CHLORINATED) LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT...
K981917 · LYY
Oon Corp. Resources
General Hospital · 189d
Cleared Dec 07, 1998
GREEN-OR DENTIN DESENSITIZER
K981972 · LBH
Centrix, Inc.
Dental · 186d
Cleared Dec 07, 1998
REAADS IGG ANTI-B2GPI TEST KIT
K982391 · MSV
Corgenix, Inc.
Immunology · 151d
Cleared Dec 07, 1998
REAADS IGM ANTI-B2GP1 TEST KIT
K982433 · MSV
Corgenix, Inc.
Immunology · 146d
Cleared Dec 07, 1998
NELLCOR PURITAN BENNETT UNIPROBE ADAPTER CABLE, UP12A, UP12B, UP12C
K982728 · DQA
Nellcor Puritan Bennett, Inc.
Anesthesiology · 124d
Cleared Dec 07, 1998
KSEA C-MOUNT ARTHROSCOPES
K983142 · HRX
Karl Storz Endoscopy
Orthopedic · 90d
Cleared Dec 07, 1998
ARSOFT
K983146 · LZA
Alliance Rubber Products Sdn. Bhd.
General Hospital · 90d
Cleared Dec 07, 1998
NEOFLOW OPTION MODEL NUMBERS 8413563, 8411900
K983219 · CBK
Drager, Inc.
Anesthesiology · 84d