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

Filters: Cleared only ×
175,820 results
32497–32520 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 24, 2016
Exceed Tx
K150702 · DYW
Great Lakes Orthodontics, Ltd.
Dental · 372d
Cleared Mar 24, 2016
Arthrex SwiveLock Anchors
K151342 · MAI
Arthrex, Inc.
Orthopedic · 310d
Cleared Mar 24, 2016
Hybernite RT
K151461 · BZE
Plastiflex Group NV
Anesthesiology · 297d
Cleared Mar 24, 2016
Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with...
K151778 · KGO
Cardinal Health 200, Inc.
General Hospital · 267d
Cleared Mar 24, 2016
X-Fix Line Additions
K151881 · KTT
Vilex IN Tennessee, Inc.
Orthopedic · 259d
Cleared Mar 24, 2016
Biomet Microfixation RibFix Blu Thoracic Fixation System
K152253 · HRS
Biomet Microfixation
Orthopedic · 227d
Cleared Mar 24, 2016
EV Insite System
K152716 · LLZ
Psp Corporation
Radiology · 185d
Cleared Mar 24, 2016
iMESH Tacker
K153202 · GDW
Thd Lap
General & Plastic Surgery · 141d
Cleared Mar 24, 2016
Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit
K153226 · NCX
Zoll Circulation, Inc.
Neurology · 139d
Cleared Mar 24, 2016
STERIZONE VP4 Sterilizer
K153392 · PJJ
Ts03, Inc.
General Hospital · 121d
Cleared Mar 24, 2016
TRUESPAN Meniscal Repair System
K153667 · MBI
Medos International SARL
Orthopedic · 94d
Cleared Mar 24, 2016
NuVasive® Lumbar Interbody Implants
K153782 · MAX
Nu Vasive, Incorporated
Orthopedic · 84d
Cleared Mar 24, 2016
Cascadia Interbody System
K160547 · MAX
K2m
Orthopedic · 27d
Cleared Mar 23, 2016
Reprocessed Steerable Introducer
K152090 · PNE
Sterilmed, Inc.
Cardiovascular · 240d
Cleared Mar 23, 2016
RejuvatoneMD
K152199 · NFO
Trophy Skin, Inc.
Neurology · 230d
Cleared Mar 23, 2016
MPO Total Knee Systems MR Labeling
K152631 · HRY
Microport Orthopedics, Inc.
Orthopedic · 190d
Cleared Mar 23, 2016
Vesalius
K152933 · GEI
Telea Electronic Engineering Srl
General & Plastic Surgery · 170d
Cleared Mar 23, 2016
VDT985US Vicks SmartTemp Thermometer
K152975 · FLL
Kaz USA, Inc., A Helen of Troy Company
General Hospital · 167d
Cleared Mar 23, 2016
Straumann Bone Level Tapered Implants
K153758 · DZE
Institut Straumann AG
Dental · 84d
Cleared CT Mar 23, 2016
ZELTIQ CoolSculpting System
K160259 · OOK
Zeltiq Aesthetics, Inc.
General & Plastic Surgery · 51d
Cleared Mar 23, 2016
Response 5.5 Spine System
K160466 · NKB
OrthoPediatrics Corp.
Orthopedic · 33d
Cleared Mar 23, 2016
PointerShell Universal, PointerShell LS
K160479 · PGW
Fiagon GmbH
Ear, Nose, Throat · 30d
Cleared Mar 22, 2016
QbCheck
K143468 · LQD
Qbtech AB
Neurology · 474d
Cleared Mar 22, 2016
Glide-On Vinyl Examination Gloves
K151754 · LYZ
Medline Industries, Inc.
General Hospital · 267d