Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
64465–64488 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 02, 2005
DATEX-OHMEDA S/5 INTERFACE MODULE E-INT
K052880 · CCK
Ge Healthcare
Anesthesiology · 21d
Cleared Nov 01, 2005
ABL80 FLEX ANALYZER
K051804 · CHL
Sendx Medical, Inc.
Chemistry · 119d
Cleared Nov 01, 2005
CP BRACKET SYSTEM
K052370 · DYW
Dentsply International
Dental · 63d
Cleared Nov 01, 2005
F1 SERIES DENTAL CHAIRS WITH OPERATIVE UNIT
K052470 · EIA
Shanghai Fimet Medical Instrument...
Dental · 54d
Cleared Nov 01, 2005
DATEX-OHMEDA S/5 MEMORY MODULE, E-MEM
K052756 · MHX
Ge Healthcare
Cardiovascular · 32d
Cleared Nov 01, 2005
MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLE
K052802 · KNW
Manan Medical Products, Inc.
Gastroenterology & Urology · 29d
Cleared Nov 01, 2005
QMS AMIKACIN REAGENTS
K052815 · KLQ
Seradyn, Inc.
Toxicology · 28d
Cleared Nov 01, 2005
MODIFICATION TO MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL FOR SIEMENS
K052827 · MOS
Medrad, Inc.
Radiology · 27d
Cleared Nov 01, 2005
CARDIOSERVER
K052883 · DQK
Datrix
Cardiovascular · 19d
Cleared Nov 01, 2005
EVENFLO ELAN BREAST PUMP
K052909 · HGX
Evenflo Company, Inc.
Obstetrics & Gynecology · 15d
Cleared Nov 01, 2005
BIS EEG MONITOR, MODEL BISX4
K052981 · OLW
Aspect Medical Systems, Inc.
Neurology · 8d
Cleared Oct 31, 2005
VP SHEATH
K051580 · DQY
Flowcardia, Inc.
Cardiovascular · 138d
Cleared Oct 31, 2005
SLIMMANAGER, MODEL SM-X, SM-E
K051589 · MNW
Aiia Communication, Inc.
Gastroenterology & Urology · 138d
Cleared Oct 31, 2005
DSNARE, MODEL 00711087
K051637 · FCK
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 133d
Cleared Oct 31, 2005
WATER FILLED TEETHER
K052105 · KKO
Royal Industries (Thailand) Public...
Dental · 89d
Cleared Oct 31, 2005
SIMILE FLOW
K052106 · EBF
Pentron Clinical Technologies
Dental · 89d
Cleared Oct 31, 2005
MIM 3.5 (CIRCA)
K052379 · LLZ
Mimvista Corp.
Radiology · 62d
Cleared Oct 31, 2005
PATHFORMER
K052770 · NWF
Path Scientific, LLC
General & Plastic Surgery · 31d
Cleared Oct 31, 2005
SYNGO MULTIMODALITY WORKPLACE (SYNGO MM WP)
K052775 · LLZ
Siemens AG Medical Solutions
Radiology · 28d
Cleared Oct 31, 2005
NON-STERILE POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE, WITH VITAMIN E
K052890 · LZA
Siam Sempermed Corp., Ltd.
General Hospital · 18d
Cleared Oct 31, 2005
ACCUVIX XQ DIAGNOSTIC ULTRASOUND SYSTEM
K052911 · IYN
Medison Co., Ltd.
Radiology · 14d
Cleared Oct 31, 2005
1125 XSB XENON FIBER-OPTIC LIGHT SOURCE
K052979 · HBI
Isolux, LLC
General & Plastic Surgery · 7d
Cleared Oct 28, 2005
OMRON NON-INVASIVE BLOOD PRESSURE MONITOR WITH AUGMENTATION INDEX, MODEL...
K050233 · DXN
Omron Healthcare, Inc.
Cardiovascular · 269d
Cleared Oct 28, 2005
HYSAFE MICRO MODULAR FORCEPS AND SCISSORS SYSTEM
K051276 · OCZ
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 164d