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
43489–43512 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 22, 2012
HARMONIC ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH + ADAPTIVE TISSUE...
K121550 · LFL
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 89d
Cleared Aug 22, 2012
SYSTEM, X-RAY, STATIONARY
K121854 · KPR
Beijing Sinopharm Hundric Mediline...
Radiology · 58d
Cleared Aug 22, 2012
GENESYS PRESSFT SUTURE ANCHOR
K121890 · MAI
Linvatec Corporation D/B/A Conmed...
Orthopedic · 55d
Cleared Aug 22, 2012
XPRESS MULTI-SINUS DILATION TOOL
K121943 · LRC
Entellus Medical, Inc.
Ear, Nose, Throat · 50d
Cleared Aug 22, 2012
ELITECH CLINICAL SYSTEMS CK NAC SL
K122083 · JHW
Elitechgroup
Chemistry · 37d
Cleared Aug 21, 2012
SUPERA VERITAS(R) INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC...
K111627 · FGE
Idev Technologies, Inc.
Gastroenterology & Urology · 438d
Cleared Aug 21, 2012
VIRTUAL SLIDE SYSTEM, OLYMPUS VS800 SYSTEM
K111914 · OEO
Olympus America Inc. / Scientific...
Pathology · 412d
Cleared Aug 21, 2012
TYSONBIO MD100 BLOOD GLUCSE MONITORING ,TYSONBIO MD100 PRO BLOOD GLUCISE...
K112916 · NBW
Tyson Bioresearch, Inc.
Chemistry · 323d
Cleared Aug 21, 2012
ENDOSERVICE ENDOSCOPIC INSTRUMENTS & ACCESSORIES AND MINIMALLY INVASIVE GI...
K113062 · FBP
Endoservice Optical Instruments GmbH
Gastroenterology & Urology · 312d
Cleared Aug 21, 2012
HY-CHLO(TM)WOUND SCRUB
K113312 · FQH
Patrin Pharma
General Hospital · 286d
Cleared Aug 21, 2012
MTA-FILLAPEX
K113568 · KIF
Paxmed International
Dental · 263d
Cleared CT Aug 21, 2012
CLEVER CHOICE
K120921 · CGA
Simple Diagnostics, Inc.
Chemistry · 147d
Cleared Aug 21, 2012
VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM, VIVID S6 DIAGNOSTIC ULTRASOUND SYSTEM
K121063 · IYN
Ge Medical System Israel , Ltd.
Radiology · 137d
Cleared Aug 21, 2012
GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DRESSING
K121485 · QSY
Hemcon Medical Technologies Europe, Ltd.
General & Plastic Surgery · 95d
Cleared Aug 21, 2012
CD HORIZON SPINAL SYSTEM
K121764 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 67d
Cleared Aug 21, 2012
BONE PLUS BCP EAGLE EYE
K122240 · LYC
Megagen Implant Co., Ltd.
Dental · 25d
Cleared Aug 20, 2012
OPTO HYALUS GREEN LASER
K111460 · HQF
Opto Eletronica S/A
Ophthalmic · 452d
Cleared Aug 20, 2012
AVS AS PEEK SPACER
K120486 · ODP
Stryker Spine
Orthopedic · 185d
Cleared Aug 20, 2012
THE PAIN PILOT (A.K.A PAIN PILOT)
K120500 · NUH
Hollywog, LLC
Neurology · 181d
Cleared Aug 20, 2012
DYNATRON THERMOSTIM PROBE-DONE
K120835 · GXY
Dynatronics Corporation
Neurology · 153d
Cleared Aug 20, 2012
SAMBA SCREW, 9MM DIA., 25MM LONG, SAMBIA SCREW, 9MM DIA., 30MM LONG, SAMBA...
K121148 · HWC
Medical Design, LLC
Orthopedic · 126d
Cleared Aug 20, 2012
ULTRASONIC NEBULIZER
K121154 · CAF
Foshan Gaunying Electronics Co., Ltd.
Anesthesiology · 126d
Cleared Aug 20, 2012
GRIDLOCK PLATING SYSTEM
K121452 · HRS
Trilliant Surgical, Ltd.
Orthopedic · 96d
Cleared Aug 20, 2012
WELKINS EMT/ICU TEMPERATURE MANAGERMENT SYSTEM
K121720 · DWJ
Welkins, LLC
Cardiovascular · 69d