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
55273–55296 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 21, 2008
NIPRO SAFETOUCH HUBER INFUSTION SET
K081210 · FPA
Nipro Medical Corp.
General Hospital · 175d
Cleared Oct 21, 2008
SPINAL INTEGRATION SPINAL-EZE INTRAOPERATIVE EPIDURAL CATHETER KIT
K081404 · BSO
Spinal Integration, LLC
Anesthesiology · 155d
Cleared Oct 21, 2008
E-Z CLEAN ELECTROSURGICAL ELECTRODE
K081791 · GEI
Megadyne Medical Products, Inc.
General & Plastic Surgery · 118d
Cleared Oct 21, 2008
ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE
K082095 · HTN
Smith & Nephew Endoscopy, Inc.
Orthopedic · 89d
Cleared Oct 21, 2008
SHOWCASE
K082135 · LLZ
Trillium Technology, Inc.
Radiology · 84d
Cleared Oct 21, 2008
GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110
K082417 · CGA
Arkray Factory USA, Inc.
Chemistry · 60d
Cleared Oct 21, 2008
TENS/EMS COMBO, EMS, TENS
K082514 · GZJ
Medihightec Medical Co., Ltd.
Neurology · 49d
Cleared Oct 21, 2008
STRAUMANN GUIDED INSTRUMENTS
K082532 · DZI
Straumann USA
Dental · 49d
Cleared Oct 21, 2008
XCHF-T160 VIDEOSCOPE
K082576 · FBN
Olympus Medical Systems Corporation
Gastroenterology & Urology · 46d
Cleared Oct 21, 2008
KOWA NONMYD ALPHA-DIII
K082767 · HKI
Kowa Co. , Ltd.
Ophthalmic · 29d
Cleared Oct 21, 2008
G-BOND PLUS
K082768 · KLE
GC America, Inc.
Dental · 29d
Cleared Oct 21, 2008
LANX CERVICAL INTERVERTEBRAL BODY FUSION DEVICE
K082774 · MAX
Lanx, LLC
Orthopedic · 29d
Cleared Oct 20, 2008
PROMEDICAL SURGICAL DRAPES, PROMEDICAL SURGICAL MAYO STAND COVER, BAND BAGS
K080629 · KKX
Promedical Products Co., Ltd.
General Hospital · 229d
Cleared Oct 20, 2008
DISPOSABLE BLOOD PRESSURE CUFF, MODEL DC100
K080854 · DXQ
Suntech Medical, Inc.
Cardiovascular · 207d
Cleared Oct 20, 2008
AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
K082006 · FAE
American Medical Systems, Inc.
Gastroenterology & Urology · 97d
Cleared Oct 20, 2008
Y-ADAPTER
K082174 · KTI
Asthmatx, Inc.
Ear, Nose, Throat · 80d
Cleared Oct 20, 2008
HYPERQ SYSTEM
K082564 · MWI
Biological Signal Processing, Ltd.
Cardiovascular · 46d
Cleared Oct 17, 2008
ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT
K073309 · LCP
Horiba Abx
Chemistry · 329d
Cleared Oct 17, 2008
CDB CLIP
K080906 · NJM
Cdb Corporation
Dental · 199d
Cleared Oct 17, 2008
INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM
K080908 · NCX
Innercool Therapies, Inc.- A Delaware...
Neurology · 199d
Cleared Oct 17, 2008
ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000
K080909 · NTH
Ikonisys, Inc.
Pathology · 199d
Cleared Oct 17, 2008
CARESENS BLOOD GLUCOSE MONITORING SYSTEM
K080923 · NBW
I-Sens, Inc.
Chemistry · 198d
Cleared Oct 17, 2008
ACCIN TOTAL KNEE SYSTEM
K081127 · JWH
Accelerated Innovation, LLC
Orthopedic · 179d
Cleared Oct 17, 2008
TENODESIS CROSS SCREW, INTERFERENCE SCREW, SUTURE BEAD
K081348 · MBI
TriMed, Inc.
Orthopedic · 156d