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
32641–32664 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 08, 2016
Ventix Knotless Anchors
K152262 · MBI
Biomet Manufacturing Corp
Orthopedic · 210d
Cleared Mar 08, 2016
CharmFlex
K152766 · ELW
Dentkist, Inc.
Dental · 166d
Cleared Mar 08, 2016
Mailuokang Self-adhesive Electrode
K152815 · GXY
Shenzhen Mailuokang Technology Co., Ltd.
Neurology · 162d
Cleared Mar 08, 2016
Propeller System
K152882 · CAF
Reciprocal Labs
Anesthesiology · 160d
Cleared Mar 08, 2016
TruGuard Custom Tongue and Jaw Positioner
K153270 · IYE
Bionix Development Corp.
Radiology · 117d
Cleared Mar 08, 2016
Erisma-LP Spinal Fixation System
K153326 · NKB
Clariance, Sas
Orthopedic · 110d
Cleared Mar 08, 2016
Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical...
K160085 · KWS
Zimmer GmbH
Orthopedic · 53d
Cleared Mar 07, 2016
Medline Epidural Catheter
K150731 · BSO
Medline Industries, Inc.
Anesthesiology · 353d
Cleared Mar 07, 2016
Bead Block
K150876 · KRD
Biocompatibles UK , Ltd.
Neurology · 341d
Cleared Mar 07, 2016
Xpert Carba-R
K152614 · PMY
Cepheid
Microbiology · 175d
Cleared Mar 07, 2016
MEDT PEN NEEDLE
K152824 · FMI
Shandong Caremed Medical Products...
General Hospital · 160d
Cleared Mar 07, 2016
URITEK TC-201 URINE CHEMISTRY TEST SYSTEM
K152835 · JFY
Teco Diagnostics, Inc.
Chemistry · 160d
Cleared Mar 07, 2016
Cios Fusion
K153244 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 119d
Cleared Mar 07, 2016
ProLift Expandable System
K153400 · MAX
Life Spine, Inc.
Orthopedic · 104d
Cleared Mar 07, 2016
Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select
K153430 · DYB
Cook Incorporated
Cardiovascular · 103d
Cleared Mar 07, 2016
iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate...
K160025 · JWH
Conformis, Inc.
Orthopedic · 61d
Cleared Mar 07, 2016
Cobbra RF Tissue Dissector
K160041 · GEI
Elliquence, LLC
General & Plastic Surgery · 59d
Cleared Mar 07, 2016
PERIMETER Interbody Fusion Device
K160418 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 20d
Cleared Mar 06, 2016
VisuCon-F Low Fibrinogen Control Plasma
K150144 · GGN
Affinity Biologicals, Inc.
Hematology · 409d
Cleared Mar 04, 2016
HARMONIC HOOK
K151136 · LFL
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 310d
Cleared Mar 04, 2016
Straumann RN Gold Abutment for Bridge
K151590 · NHA
Straumann USA, LLC
Dental · 266d
Cleared Mar 04, 2016
Family of Steam Sterilizers B 28 series
K151597 · FLE
Cefla S.C.
General Hospital · 266d
Cleared Mar 04, 2016
LOCATOR F-Tx Attachment System
K151789 · NHA
Zest Anchors, LLC
Dental · 247d
Cleared Mar 04, 2016
SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens
K151847 · LPL
Smart Performer Corp. , Ltd.
Ophthalmic · 241d