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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
51793–51816 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 17, 2009
INDISCAL ASPIRATION DEVICE AND ACCESSORIES
K092877 · HRX
Baylis Medical Co., Inc.
Orthopedic · 60d
Cleared Nov 17, 2009
SELECTCORE VARIABLE THROW BIOPSY DEVICE MODEL 991014, 991514, 991018, 991518,...
K093256 · KNW
Inrad
Gastroenterology & Urology · 29d
Cleared Nov 17, 2009
VARIAN INTERSTITIAL TITANIUM NEEDLES
K093291 · JAQ
Varian Medical Systems, Inc.
Radiology · 27d
Cleared Nov 17, 2009
VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM
K093337 · OCC
Nanosphere, Inc.
Microbiology · 22d
Cleared Nov 17, 2009
CSI MODEL 5K MANAGED HEALTH SYSTEM KIOSK
K093389 · DXN
Computerized Screening, Inc.
Cardiovascular · 18d
Cleared Nov 17, 2009
LUNGPOINT PROCEDURE PLANNING
K093423 · LLZ
Broncus Technologies, Inc.
Radiology · 14d
Cleared Nov 16, 2009
KRYPTONITE BONE CEMENT
K091382 · GXP
Doctors Research Group, Inc.
Neurology · 189d
Cleared Nov 16, 2009
GSD INTENSE PULSED LIGHT SYSTEM, MODELS: GP666C4, GP666C
K091664 · ONF
Shenzhen Gsd Tech Co., Ltd.
General & Plastic Surgery · 160d
Cleared Nov 16, 2009
SUPERCHECK 1 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 6268
K091815 · NBW
Biotest Medical Corp.
Chemistry · 151d
Cleared Nov 16, 2009
XTEND ANTERIOR CERVICAL PLATE SYSTEM
K092146 · KWQ
Globus Medical, Inc.
Orthopedic · 124d
Cleared Nov 16, 2009
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168KB
K092163 · DXN
Health & Life Co., Ltd.
Cardiovascular · 123d
Cleared Nov 16, 2009
ELECSYS HCG+B CALCHECK 5
K092168 · JJX
Roche Diagnostics
Chemistry · 118d
Cleared Nov 16, 2009
OXIPROBE, MODELS BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600P
K092549 · DQA
Bio Medical Technologies Co., Ltd.
Anesthesiology · 89d
Cleared Nov 13, 2009
T.E.A.R. TECH3
K090532 · IPF
Vision Quest Industries, Inc.
Physical Medicine · 259d
Cleared Nov 13, 2009
AKITA JET
K090730 · CAF
Activaero America, Inc.
Anesthesiology · 239d
Cleared Nov 13, 2009
IMPLICITGUIDE SURGICAL SUTURE SYSTEM
K091061 · GAT
Implicitcare, LLC
General & Plastic Surgery · 213d
Cleared Nov 13, 2009
PHILIPS TELEMEDICINE SERVER/SYSTEM, MODEL 861441
K091176 · MSX
Philips Medical Systems
Cardiovascular · 205d
Cleared Nov 13, 2009
LEFORTE NEUROSYSTEM BONE SCREW
K091686 · HWC
Jeil Medical Corporation
Orthopedic · 157d
Cleared Nov 13, 2009
BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY
K091724 · MKZ
Becton, Dickinson & CO
Microbiology · 155d
Cleared Nov 13, 2009
BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY
K091730 · LSL
Becton, Dickinson & CO
Microbiology · 155d
Cleared Nov 13, 2009
LUNETTE MENSTRUAL CUP, MODELS 1 AND 2
K091754 · HHE
Lune Group , Ltd.
Obstetrics & Gynecology · 150d
Cleared Nov 13, 2009
SPORT-ELEC BODY CONTROL SYSTEM
K091865 · NGX
Sport-Elec
Physical Medicine · 147d
Cleared Nov 13, 2009
STA - FREE PS CALIBRATOR
K092113 · JIX
Diagnostica Stago, Inc.
Hematology · 122d
Cleared Nov 13, 2009
ETRAX NEEDLE SYSTEM, ETRAX VARIABLE ANGLE NEEDLE GUIDANCE SYSTEM, VIRTUTRAX...
K092619 · IYO
Civco
Radiology · 79d