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
50521–50544 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 04, 2010
KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES
K100306 · JOW
Covidien
Cardiovascular · 90d
Cleared May 04, 2010
PERI-LOC LOCKING HOLE INSERTS AND CABLE ACCESSORIES
K100325 · HWC
Smith & Nephew, Inc.
Orthopedic · 89d
Cleared May 04, 2010
SPERMCHECK FERTILITY
K100341 · POV
Princeton BioMeditech Corp.
Hematology · 88d
Cleared May 04, 2010
DERMABOND NX ADHESIVE MODEL: DNX6, DNX12
K100423 · MPN
Ethicon, Inc.
General & Plastic Surgery · 77d
Cleared May 04, 2010
ADULT CEREBRAL-SOMATIC OXIMETRY SENSOR, PEDIATRIC CEREBRAL-SOMATIC OXIMETRY...
K100523 · NMD
Hygia Health Services, Inc.
Cardiovascular · 69d
Cleared May 04, 2010
HALLMARK ANTERIOR CERVCIAL PLATE SYSTEM, HALLMARK FIVE-LEVEL CERVICAL PLATES
K100614 · KWQ
Blackstone Medical, Inc.
Orthopedic · 61d
Cleared May 03, 2010
ENGSTROM CARESTATION, ENGSTROM PRO
K093886 · CBK
Datex-Ohmeda Inc., A Division of...
Anesthesiology · 136d
Cleared Apr 30, 2010
TSRH SPINAL SYSTEM
K091797 · NKB
Medtronic Sofamor Danek
Orthopedic · 317d
Cleared Apr 30, 2010
BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM
K091958 · OQY
Glenveigh Surgical, LLC
Obstetrics & Gynecology · 303d
Cleared Apr 30, 2010
VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR
K092033 · FFK
Elmed USA
Gastroenterology & Urology · 298d
Cleared Apr 30, 2010
BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTES
K092554 · MQH
Sunlight Medical, Inc.
Obstetrics & Gynecology · 253d
Cleared Apr 30, 2010
H/S CATHETER SET 5 FRENCH, MODEL 61-5005F, H/S CATHETER SET 7 FRENCH, MODEL...
K092969 · LKF
Sterling Medical, Inc.
Obstetrics & Gynecology · 217d
Cleared Apr 30, 2010
RINGLOC + HYBRID ACETABULAR SYSTEM
K093235 · KWA
Biomet, Inc.
Orthopedic · 197d
Cleared Apr 30, 2010
STRETCH VINYL EXAMINATION GLOVE, POWDER FREE, YELLOW/WHITE
K093263 · LYZ
Qingdao Lang Hui Import & Export Co.,...
General Hospital · 193d
Cleared CT Apr 30, 2010
C7 XR IMAGING SYSTEM WITH C7 DRAGONFLY IMAGING CATHETER AND DISPOSABLE...
K093857 · NQQ
Lightlab Imaging, Inc.
General & Plastic Surgery · 135d
Cleared Apr 30, 2010
ILUMA VISION MODEL VERSION 2.2
K094064 · LLZ
3M Imtec
Radiology · 120d
Cleared Apr 30, 2010
GRYPHON T BR DS ANCHOR W/ORTHOCORD, GRYPHON T BR ANCHOR W /ORTHOCORD, GRYPHON...
K100012 · MAI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 116d
Cleared Apr 30, 2010
VSI TORQUE DEVICE
K100093 · DQX
Vascular Solutions, Inc.
Cardiovascular · 107d
Cleared Apr 30, 2010
QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING,...
K100278 · DTZ
Maquet Cardiopulmonary, AG
Cardiovascular · 88d
Cleared Apr 30, 2010
CAAS QVA 3D, CAAS QCA 3D
K100292 · LLZ
Pie Medical Imaging BV
Radiology · 87d
Cleared Apr 30, 2010
OPTIBOND SE
K100347 · KLE
Kerr Corporation
Dental · 77d
Cleared Apr 30, 2010
CLICKFINE PEN NEEDLE
K100436 · FMI
Ypsomed AG
General Hospital · 73d
Cleared Apr 30, 2010
AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 5MM LOCKING INSERTS
K100475 · HRS
Howmedica Osteonics Corp.
Orthopedic · 71d
Cleared Apr 30, 2010
DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CIRCULAR STAPLER MODEL KYGW-25.5,...
K100723 · GDW
Changzhou Kangdi Medical Stapler Co.,...
General & Plastic Surgery · 46d