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
47089–47112 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 01, 2011
MERIT MARQUIS FLOW SWITCH
K110643 · DQO
Merit Medical Systems, Inc.
Cardiovascular · 119d
Cleared Jul 01, 2011
STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS
K110682 · KCT
Case Medical, Inc.
General Hospital · 113d
Cleared Jul 01, 2011
CORTEX CO2 / ER:YAG LASER SYSTEM
K110897 · GEX
Sandstone Medical Technologies, LLC
General & Plastic Surgery · 93d
Cleared Jul 01, 2011
ZIMMER SEGMENT SYSTEM TRABECULAR METAL PROXIMAL TIBIAL COMPONENT, TRABECULAR...
K110940 · KRO
Zimmer, Inc.
Orthopedic · 88d
Cleared Jul 01, 2011
TRIGEN LOW PROFILE BONE SCREW
K111025 · HSB
Smith & Nephew, Inc.
Orthopedic · 79d
Cleared Jul 01, 2011
FORA POCT MANAGMENT SYSTEM
K111029 · NBW
Taidoc Technology Corporation
Chemistry · 79d
Cleared Jul 01, 2011
AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE...
K111118 · OTP
American Medical Systems
Obstetrics & Gynecology · 71d
Cleared Jul 01, 2011
ENCORE TONGUE SUSPENSION SYSTEM (MONOFILAMENT #1 SUSPENSION SUTURE), ENCORE...
K111179 · ORY
Siesta Medical, Inc.
Dental · 65d
Cleared Jul 01, 2011
ENDOSCOUT TRACKING SYSTEM
K111226 · LNH
Robin Medical, Inc.
Radiology · 60d
Cleared Jul 01, 2011
U2 HIP SYSTEM
K111546 · LPH
United Orthopedic Corp.
Orthopedic · 28d
Cleared Jun 30, 2011
SENSICARE POWDER-FREE POLYMER COATED POLYSOPRENE SURGICAL GLOVES, STERILE
K102177 · KGO
Medline Industries, Inc.
General Hospital · 332d
Cleared Jun 30, 2011
PROVU (TM) DENTAL X-RAY SYSTEM
K102573 · EAP
Advanced Image Science, Inc.
Radiology · 294d
Cleared Jun 30, 2011
EZONO 3000
K102813 · IYN
Life-Tech, Inc.
Radiology · 275d
Cleared Jun 30, 2011
SIROCCO THERMAL REGULATING SYSTEM
K102856 · DWJ
Galmaz Biotech S.L.
Cardiovascular · 274d
Cleared Jun 30, 2011
GC AADVA BO AC ABUTMENTS
K103234 · NHA
GC America, Inc.
Dental · 240d
Cleared Jun 30, 2011
OCTANE-C INTERBODY FUSION DEVICE SYSTEM
K103655 · ODP
Exactech, Inc.
Orthopedic · 197d
Cleared Jun 30, 2011
ZYSTON ARC INTERBODY SPACER
K110650 · MAX
Biomet Spine (Aka Ebi, LLC)
Orthopedic · 118d
Cleared Jun 30, 2011
SCANORA 3D
K110839 · OAS
Soredex Palodex Group OY
Radiology · 97d
Cleared Jun 30, 2011
CLIO/CLIOSOFT
K110886 · LLZ
Sota Precision Optics, Inc.
Radiology · 92d
Cleared Jun 30, 2011
ENTERPRISE ELECTROPHYSIOLOGY SYSTEM
K110967 · OMC
Neuralynx, Inc.
Neurology · 85d
Cleared Jun 30, 2011
SUPER PORCELAIN EX-3 UNIVERSAL OPAQUE
K111107 · EIH
Noritake Co., Inc.
Dental · 71d
Cleared Jun 30, 2011
CANNON II PLUS CHRONIC HEMODIALYSIS CATHETER, EDGE CHRONIC HEMODIALYSIS...
K111117 · MSD
Teleflexmedical, Inc.
Gastroenterology & Urology · 70d
Cleared Jun 30, 2011
S8 ASPEN WITH H4I PLUS
K111148 · BZD
ResMed Corp
Anesthesiology · 69d
Cleared Jun 30, 2011
GMD UNIVERSAL URINARY INCONTINENCE SLING
K111219 · OTN
Generic Medical Device, Inc.
Gastroenterology & Urology · 59d