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
36721–36744 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 05, 2014
LARVAL DEBRIDEMENT THERAPY PRODUCTS - LARVAE 100/200/300 AND BIOBAG...
K142020 · NQK
Biomonde
General & Plastic Surgery · 103d
Cleared Nov 05, 2014
E-Shield Multi-paried Subdermal Needle Electrodes
K142470 · GXZ
Neuroinvent, Inc.
Neurology · 63d
Cleared Nov 05, 2014
Acrobat Calibrated Tip Wire Guide
K142950 · OCY
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 26d
Cleared Nov 04, 2014
DUREX EMBRACE PERSONAL LUBRICANT
K140193 · NUC
Reckitt Benckiser, LLC
Obstetrics & Gynecology · 281d
Cleared Nov 04, 2014
PASS LP SPINAL SYSTEM
K140738 · MNI
Medicrea International
Orthopedic · 224d
Cleared Nov 04, 2014
LIAT STREP A ASSAY
K141338 · PGX
Iquum, Inc.
Microbiology · 167d
Cleared Nov 04, 2014
RENOVIS SURGICAL POROUS ACETABULAR CUP SYSTEM
K141676 · LPH
Renovis Surgical Technologies, Inc.
Orthopedic · 134d
Cleared Nov 04, 2014
Unimed Disposable ECG lead wires
K142489 · DSA
Unimed Medical Supplies, Inc.
Cardiovascular · 61d
Cleared Nov 03, 2014
STERILUCENT SELF-CONTAINED BIOLOGICAL INDICATOR
K141238 · FRC
Sterilucent, Inc.
General Hospital · 174d
Cleared Oct 31, 2014
VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM
K140008 · GEI
Terumo Cardiovascular Systems...
General & Plastic Surgery · 302d
Cleared Oct 31, 2014
TOUAREG NP CLOSEFIT DENTAL IMPLANTS SYSTEM
K140293 · DZE
Adin Dental Implants Systems , Ltd.
Dental · 268d
Cleared Oct 31, 2014
STERILUCENT PSD-85 HYDROGEN PEROXIDE STERILIZER
K140464 · MLR
Sterilucent, Inc.
General Hospital · 249d
Cleared Oct 31, 2014
UNIEVER DISPOSABLE SPINAL ANESTHESIA NEEDLE
K141126 · BSP
Unisis Corp.
Anesthesiology · 183d
Cleared Oct 31, 2014
NOVABONE BIOACTIVE STRIP
K141207 · MQV
Novabone Products, LLC
Orthopedic · 175d
Cleared Oct 31, 2014
STERILUCENT PROCESS CHALLENGE DEVICE
K141312 · FRC
Sterilucent, Inc.
General Hospital · 164d
Cleared Oct 31, 2014
IMPLANT STUDIO
K141570 · LLZ
3Shape Medical A/S
Radiology · 141d
Cleared Oct 31, 2014
NAWALUTION SKIN AND WOUND CLEANSER
K141660 · FRO
Nawa Heilmittel GmbH
General & Plastic Surgery · 133d
Cleared Oct 31, 2014
PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
K141700 · MUH
Genoray Co., Ltd.
Radiology · 129d
Cleared Oct 31, 2014
IQQA-BODYIMAGING SOFTWARE
K141745 · LLZ
Edda Technology
Radiology · 123d
Cleared Oct 31, 2014
T:SLIM INSULIN DELIVERY SYSTEM
K141758 · LZG
Tandem Diabetes Care, Inc.
General Hospital · 123d
Cleared Oct 31, 2014
RAPIDRESULTS
K141881 · LLZ
Ramsoft, Inc.
Radiology · 112d
Cleared Oct 31, 2014
SPINEMASK TRACKER, SPINEMAP 3D 3.0-SOFTWARE,SPINEMAP 3D 3.0-UPGREADE,...
K141941 · OLO
Stryker Corporate
Orthopedic · 106d
Cleared Oct 31, 2014
DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR SWBPM22 SERIES
K142088 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 91d
Cleared Oct 31, 2014
NS3000 Holmium Laser System
K142286 · GEX
New Star Lasers, Inc.
General & Plastic Surgery · 74d