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

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176,076 results
66241–66264 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 11, 2005
GENEROS, MODELS GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G,...
K050666 · MQV
Berkeley Advanced Biomaterials, Inc.
Orthopedic · 28d
Cleared Apr 11, 2005
EXPEDIUM SPINE SYSTEM SPINOUS PROCESS FUSION PLATE
K050675 · MNI
Depuy Spine, Inc.
Orthopedic · 26d
Cleared Apr 11, 2005
ZIMMER TRABECULAR METAL HUMERAL STEM, SIZES 6MM AND 8MM
K050761 · KWT
Zimmer, Inc.
Orthopedic · 18d
Cleared Apr 11, 2005
LANX ANTERIOR CERVICAL PLATE SYSTEM
K050774 · KWQ
Lanx, LLC
Orthopedic · 17d
Cleared Apr 11, 2005
MODIFICATION TO: SPECTRUMTM CERVICAL SPINAL SYSTEM
K050804 · KWQ
Aesculap, Inc.
Orthopedic · 12d
Cleared Apr 11, 2005
CHARLOTTE SNAP-OFF SCREW
K050819 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 11d
Cleared Apr 08, 2005
TRUGLYDE ABSORBABLE POLYGLYCOLIC ACID SURGICAL SUTURE
K041515 · GAM
Sutures India Private Limited
General & Plastic Surgery · 305d
Cleared Apr 08, 2005
DUREX PLAY TINGLING LUBRICANT
K042958 · NUC
Ssl Americas, Inc.
Obstetrics & Gynecology · 163d
Cleared Apr 08, 2005
VANGUARD REPROCESSED DILATING TIP AND BLUNT TROCARS
K043253 · NLM
Vanguard Medical Concepts, Inc.
Gastroenterology & Urology · 135d
Cleared Apr 08, 2005
ONE STEP HCG URINE PREGNANCY TEST
K043443 · LCX
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 115d
Cleared Apr 08, 2005
EASYGLUCO IGM-0002 G2
K043512 · CGA
American Healthcare, Inc.
Chemistry · 109d
Cleared Apr 08, 2005
ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE
K043529 · NDC
Roche Diagnostics Corp.
General Hospital · 108d
Cleared Apr 08, 2005
BLOOD GLUCOSE MONITORING SYSTEM
K043543 · NBW
American Healthcare, Inc.
Chemistry · 109d
Cleared Apr 08, 2005
BLOOD-PRESSURE METER, BPW120
K050083 · DXN
Idt Technology Limited
Cardiovascular · 85d
Cleared Apr 08, 2005
MALE NATURAL RUBBER LATEX CONDOM
K050244 · HIS
Nrs Global Partners
Obstetrics & Gynecology · 65d
Cleared Apr 08, 2005
HRW-63-8 WRIST ARRAY COIL
K050622 · MOS
Mri Devices Corporation
Radiology · 29d
Cleared Apr 08, 2005
TRAXYLOC-1 SYSTEM
K050663 · IZH
Traxyz Medical, Inc.
Radiology · 24d
Cleared Apr 08, 2005
FLXIS
K050692 · JAA
Philips Medical Systems North America...
Radiology · 22d
Cleared Apr 08, 2005
MODIFICATION TO: REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH...
K050704 · KPR
General Electric Co.
Radiology · 21d
Cleared Apr 08, 2005
LANO-E POWDER-FREE NITRILE EXAMINATION GLOVE
K050765 · LZA
N.S. Uni-Gloves Sdn. Bhd.
General Hospital · 15d
Cleared Apr 08, 2005
LUPINE LOOP
K050771 · GAM
Depuy Mitek, A Johnson & Johnson Company
General & Plastic Surgery · 14d
Cleared Apr 07, 2005
ZOLL E SERIES DEFIBRILLATOR
K042007 · MKJ
Zoll Medical Corp
Cardiovascular · 255d
Cleared Apr 07, 2005
ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY
K042411 · NRP
Axis-Shield , Ltd.
Toxicology · 212d
Cleared Apr 07, 2005
SURGITRON RADIOLASE II
K042710 · GEI
Ellman Int'L, Inc.
General & Plastic Surgery · 189d