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

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175,820 results
38329–38352 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 28, 2014
SPLIT CATH RG
K130889 · MSD
Medcomp
Gastroenterology & Urology · 395d
Cleared Apr 28, 2014
AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPAND
K132042 · HOY
X6d, Ltd.
Ophthalmic · 300d
Cleared Apr 28, 2014
ARASYS
K132179 · NGX
Ion Genius, Inc.
Physical Medicine · 287d
Cleared Apr 28, 2014
ACESSA GUIDANCE HANDPIECE
K132184 · HFG
Halt Medical, Inc.
Obstetrics & Gynecology · 287d
Cleared Apr 28, 2014
OPTEO, VIDEOGRAPH HD
K133271 · MUH
Owandy
Radiology · 186d
Cleared Apr 28, 2014
EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD...
K133537 · LFR
Eps Bio Technology Corp.
Chemistry · 161d
Cleared Apr 28, 2014
PURACYN PLUS SKIN AND WOUND
K133542 · FRO
Innovacyn, Inc.
General & Plastic Surgery · 161d
Cleared Apr 28, 2014
ARTIS ONE
K133580 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 158d
Cleared Apr 28, 2014
GSP NEONATAL TOTAL GALACTOSE KIT
K133652 · JIA
Wallac Oy, A Subsidiary of...
Chemistry · 152d
Cleared Apr 28, 2014
ANATOMIC PEEK PTC CERVICAL FUSION SYSTEM
K133653 · ODP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 152d
Cleared Apr 28, 2014
EMPRINT ABLATION SYSTEM
K133821 · NEY
Covidien, LLC
General & Plastic Surgery · 133d
Cleared Apr 28, 2014
BRELLA-SPEC(TM) VAGINAL SPECULUM
K133857 · HIB
Proa Medical, Inc.
Obstetrics & Gynecology · 130d
Cleared Apr 28, 2014
SUCTION PUMP
K140031 · JCX
Ding Hwa Co., Ltd.
General & Plastic Surgery · 112d
Cleared Apr 28, 2014
XENMATRIX SURGICAL GRAFT
K140501 · FTM
C. R. Bard
General & Plastic Surgery · 60d
Cleared Apr 28, 2014
SURGISEAL TOPICAL SKIN ADHESIVE/SURGISEAL STYLUS TOPICAL SKIN ADHESIVE
K140517 · MPN
Adhezion Biomedical, LLC
General & Plastic Surgery · 59d
Cleared Apr 28, 2014
CONSTELLATION MULTIPLE ELECTRODE RECORDING & PACING CATHETER
K140733 · MTD
Boston Scientific Corporation
Cardiovascular · 35d
Cleared Apr 28, 2014
CAIMAN SEAL AND CUT TECHNOLOGY
K140839 · GEI
Aesculap, Inc.
General & Plastic Surgery · 26d
Cleared Apr 25, 2014
OCTANE ELEVATE SPINAL IMPLANT SYSTEM
K123607 · MAX
Exactech, Inc.
Orthopedic · 520d
Cleared Apr 25, 2014
ENTAX ULTRASOUND VIDEO BRONCHOSCOPE EB-1970UK + HI VISIN PREIRUS
K131946 · EOQ
Pentax Medical Company
Ear, Nose, Throat · 302d
Cleared Apr 25, 2014
THE MOSES ELITE APPLIANCE
K132933 · LRK
Allen J. Moses, Dds, Ltd.
Dental · 219d
Cleared Apr 25, 2014
GEL-BEAD EMBOLIZATION SPHERES
K133237 · KRD
Vascular Solutions, Inc.
Cardiovascular · 186d
Cleared Apr 25, 2014
FORA CARE BLOOD PRESSURE MONITORING SYSTEM
K133588 · DXN
Foracare, Inc.
Cardiovascular · 155d
Cleared Apr 25, 2014
SMARTTOUCH
K133951 · CAF
Nexus6, Ltd.
Anesthesiology · 123d
Cleared Apr 25, 2014
2300 SERIES MGO PORTABLE OXYGEN
K134023 · CAW
Ultra Electronics Limited Precision...
Anesthesiology · 116d