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
43009–43032 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 17, 2012
ENDOWRIST STAPLER SYSTEM
K113706 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 306d
Cleared Oct 17, 2012
GLOBAL MEDI PRODUCTS RETRACTABLE SAFETY SYRINGE
K120641 · MEG
Global Medi Products
General Hospital · 229d
Cleared Oct 17, 2012
THS INSTRUMENT TRAY
K120947 · KCT
Hologic, Inc.
General Hospital · 202d
Cleared Oct 17, 2012
NU SLEEP
K121344 · LRK
Rh Associates, LLC
Dental · 166d
Cleared Oct 17, 2012
BOX PEEK VBR SYSTEM,
K121581 · MAX
Innovasis, Inc.
Orthopedic · 140d
Cleared Oct 17, 2012
STINGRAY CERVICAL CAGE
K122085 · ODP
Omni Surgical, LP Dba Spine360
Orthopedic · 93d
Cleared Oct 17, 2012
POWDER FREE NITRILE EXAMINATION GLOVE-BLUE (CHEMOTHERAPY)
K122131 · LZA
Matang Mfg. Sdn. Bhd.
General Hospital · 91d
Cleared Oct 17, 2012
QBTES
K122149 · LQD
Qbtech AB
Neurology · 90d
Cleared Oct 17, 2012
LIQUICKEK IMMUNOASSAY PLUS CONTROL, LEVEL 1 MODEL 267, LIQUICHEK IMMUNOASSAY...
K122838 · JJY
Bio-Rad Laboratories
Chemistry · 30d
Cleared Oct 17, 2012
INSPIRE 8F DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND...
K122844 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 30d
Cleared Oct 17, 2012
CHARTER GUIDEWIRE
K122856 · DQX
Brivant, Ltd.
Cardiovascular · 29d
Cleared Oct 16, 2012
ME AGAIN(R) LONG LASTING VAGINAL MOISTURIZER, VH ESSENTIALS (R) LONG LASTING...
K112217 · NUC
Polichem S.A
Obstetrics & Gynecology · 441d
Cleared Oct 16, 2012
DISPOSABLE SURGICAL GOWNS
K120192 · FYA
Weihai Hongyu Nonwoven Fabric...
General Hospital · 267d
Cleared Oct 16, 2012
ENDOSCOPIC ULTRASOUND CENTER EU-Y0006
K121564 · IYN
Olympus Medical Systems Corp.
Radiology · 140d
Cleared Oct 16, 2012
AMS LARGE PORE POLYPROPHLENE MESH
K121805 · OTO
American Medical Systems
Obstetrics & Gynecology · 119d
Cleared Oct 16, 2012
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLOR
K121992 · LZA
Xinwei (Shandong) Plastic and Rubber...
General Hospital · 102d
Cleared Oct 16, 2012
SMITH & NEPHEW R3 CONSTRAINED LINERS
K122139 · KWZ
Smith & Nephew, Inc.
Orthopedic · 89d
Cleared Oct 16, 2012
TOWERLOX PEDICLE SCREW SYSTEM
K122332 · MNI
Captiva Spine
Orthopedic · 75d
Cleared Oct 16, 2012
MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, PINK
K122465 · LZA
Industrial Clothings, Ltd.
General Hospital · 64d
Cleared Oct 16, 2012
ACCUMESH DEPLOYMENT SYSTEM
K123066 · ORQ
Covidien, LLC
General & Plastic Surgery · 15d
Cleared Oct 15, 2012
TYVEK SELF-SEAL POUCHES ,TYVEK HEAT-SEAL ROLLS
K112087 · KCT
Advanced Sterilization Products
General Hospital · 452d
Cleared Oct 15, 2012
AESKUSLIDES ANA HEP-2
K120889 · DHN
Aesku Diagnostics
Immunology · 206d
Cleared Oct 15, 2012
PROTECH DENT
K121272 · OBR
Akervall Technologies, Inc.
Dental · 171d
Cleared Oct 15, 2012
REUSABLE CUTANEOUS ELECTRODE
K121483 · GXY
Ampcare, LLC
Neurology · 150d