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
88081–88104 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 16, 1998
SIGNA PROFILE SMALL HEAD COIL
K982972 · MOS
GE Medical Systems
Radiology · 83d
Cleared Nov 16, 1998
SKULL BASE INSTATRAK SYSTEM
K982994 · LLZ
Visualization Technology, Inc.
Radiology · 81d
Cleared Nov 16, 1998
XRAY VISION
K983111 · LLZ
Apteryx, Inc.
Radiology · 73d
Cleared Nov 16, 1998
MARK 5000 PHASED ARRAY SHOULDER COIL
K983143 · MOS
Usa Instruments, Inc.
Radiology · 69d
Cleared Nov 16, 1998
CYTOPREP
K983181 · HHI
Cytoprep Inc. Est.
Obstetrics & Gynecology · 66d
Cleared Nov 16, 1998
DUREX LUBRAGEL LATEX CONDOM
K983380 · HIS
London Intl., LLC
Obstetrics & Gynecology · 52d
Cleared Nov 16, 1998
SAFETEX CERVICAL SCRAPER (PLASTIC)
K983428 · HHT
Andwin Scientific
Obstetrics & Gynecology · 48d
Cleared Nov 16, 1998
25-HYDROXYVITAMIN D 125I RIA KIT
K983617 · LCI
DiaSorin, Inc.
Chemistry · 32d
Cleared Nov 16, 1998
PLANMED SOPHIE & PLANNED SOPHIE CLASSIC
K983659 · IZH
Planmed OY
Radiology · 28d
Cleared Nov 16, 1998
NAPA EIA ASSAY
K983812 · LAN
Diagnostic Reagents, Inc.
Toxicology · 19d
Cleared Nov 16, 1998
ABBOTT AXSYM MYOGLOBIN
K983848 · DDR
Abbott Laboratories
Chemistry · 17d
Cleared Nov 16, 1998
SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM ENHANCEMENT, ADDITIONAL...
K983980 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 7d
Cleared Nov 13, 1998
DISPOSABLE CANNULA TRACHEOSTOMY TUBE, WITH INNER CANNULA
K970811 · JOH
Pneumocare, Inc.
Anesthesiology · 618d
Cleared Nov 13, 1998
NIR BILIARY STENT
K973171 · FGE
Medinol, Ltd.
Gastroenterology & Urology · 445d
Cleared Nov 13, 1998
MEDI-TRACE 4103 NEONATAL ELECTRODE
K981964 · DRX
Graphic Controls Corp.
Cardiovascular · 162d
Cleared Nov 13, 1998
HEARTLINK, MODEL II
K982803 · QYX
Cardiac Telecom Corp.
Cardiovascular · 95d
Cleared Nov 13, 1998
METROSOFT II, METROSOFT TORIC, METROLITE, METROTINT, SATUREYES, SATUREYES...
K983021 · LPL
Metrosoft, Inc.
Ophthalmic · 74d
Cleared Nov 13, 1998
FRACTURE RISK OPTION FOR THE QDR BONE DENSITOMETER, MODEL#S QDR4500, QDR2000,...
K983028 · KGI
Hologic, Inc.
Radiology · 74d
Cleared Nov 13, 1998
HEMOCOR HPH 700 HEMOCONCENTRATOR
K983085 · KDI
Minntech Corp.
Gastroenterology & Urology · 71d
Cleared Nov 13, 1998
BLOWER/MISTER
K983135 · FQH
Cardiothoracic Systems, Inc.
General Hospital · 66d
Cleared Nov 13, 1998
MUCOPREN SOFT RELINING SYSTEM
K983357 · EBI
Roydent Dental Products, Inc.
Dental · 50d
Cleared Nov 13, 1998
PANAVIA F
K983361 · EMA
Kuraray America, Inc.
Dental · 50d
Cleared Nov 13, 1998
CARDIOBEEPER CB250
K983582 · DXH
Merdian Medical Technologies , Ltd.
Cardiovascular · 31d
Cleared Nov 13, 1998
STERNGOLD IMPLAMED WIDE PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND...
K983786 · DZE
Sterngold/Implamed
Dental · 17d