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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
36481–36504 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 19, 2014
Predicate III Guidewire
K142397 · OCY
Lake Region Medical
Gastroenterology & Urology · 23d
Cleared Sep 19, 2014
Extension Set with BD Q-Syte Luer Access Split Septum
K142527 · FPA
Acacia, Inc.
General Hospital · 11d
Cleared Sep 18, 2014
IROOT FM
K130312 · KIF
Innovative Bioceramix, Inc.
Dental · 588d
Cleared Sep 18, 2014
FIA Blood Glucose Monitoring System (G2)
K131173 · NBW
Hmd Biomedical, Inc.
Chemistry · 511d
Cleared Sep 18, 2014
EBM IDO VIEWER
K140399 · LLZ
Ebm Technologies USA, LLC
Radiology · 212d
Cleared Sep 18, 2014
MIVI 6F GUIDE CATHETER
K140557 · DQY
Mivi, LLC
Cardiovascular · 197d
Cleared Sep 18, 2014
MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
K140613 · PGN
Ellipse Technologies, Inc.
Orthopedic · 192d
Cleared Sep 18, 2014
CORTEX ID SUITE
K141074 · KPS
Ge Medical Systems, LLC
Radiology · 146d
Cleared Sep 18, 2014
DISCOVERY IQ
K141477 · KPS
Ge Medical Systems, LLC
Radiology · 106d
Cleared Sep 18, 2014
DENTAL IMAGING SOFTWARE
K141607 · LLZ
Trophy
Radiology · 94d
Cleared Sep 18, 2014
ACUVUE (ETAFILCON A) SOFT CONTACT LENS FOR PRESBYOPIA
K141670 · LPL
Johnson & Johnson Vision Care, Inc.
Ophthalmic · 87d
Cleared Sep 18, 2014
EDWARDS ESHEATH INTRODUCER SET
K141696 · DYB
Edwards Lifesciences
Cardiovascular · 86d
Cleared Sep 18, 2014
XTRAFIX EXTERNAL FIXATION SYSTEM, XTRAFIX SMALL EXTERNAL FIXATION SYSTEM
K141697 · KTT
Zimmer, Inc.
Orthopedic · 86d
Cleared Sep 18, 2014
CMDR-2ST & CMDR-2SLWT DIGITAL PORTABLE X-RAY
K141885 · IZL
Minxray, Inc.
Radiology · 69d
Cleared Sep 18, 2014
MOBILEDIAGNOST WDR
K141895 · IZL
Sedecal., Sa.
Radiology · 66d
Cleared Sep 18, 2014
TRUE BA V BALLOON VALVULOPLASTY CATHETER
K141985 · OZT
C.R. Bard, Inc.
Cardiovascular · 58d
Cleared Sep 18, 2014
RANDOX ALDOLASE CALIBRATION SERUM
K142181 · JIT
Randox Laboratories Limited
Chemistry · 41d
Cleared Sep 18, 2014
Veenstra Instruments VDC-506 Dose Calibrator
K142325 · KPT
Comecer Netherlands B.V.
Radiology · 29d
Cleared Sep 17, 2014
DA VINVI SURGICAL SYSTEM
K123329 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 691d
Cleared Sep 17, 2014
TRANSONIC HCM 103 SYSTEM
K134035 · DXG
Transonic Systems, Inc.
Cardiovascular · 260d
Cleared Sep 17, 2014
TREKKER, TREKKER TRANSIT
K140416 · IOR
Convaid Products, Inc.
Physical Medicine · 211d
Cleared Sep 17, 2014
Lung Density Analysis
K141069 · JAK
Imbio, LLC
Radiology · 146d
Cleared Sep 17, 2014
ELECTRONIC PULSE STIMULATOR
K141260 · NUH
Shenzhen Jingkehui Electronic Co.., Ltd.
Neurology · 125d
Cleared Sep 17, 2014
AXIOM 2.8
K141450 · DZE
Anthogyr Sas
Dental · 107d