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
35089–35112 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 11, 2015
Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission...
K142543 · KQO
ACON Laboratories, Inc.
Chemistry · 243d
Cleared May 11, 2015
Renovis Surgical Hip Replacement System
K143647 · OQG
Renovis Surgical Technologies, Inc.
Orthopedic · 140d
Cleared May 11, 2015
Elite Nitinol Fixation System
K150125 · JDR
Biomedical Enterprises, Inc.
Orthopedic · 111d
Cleared May 11, 2015
Life Spine Cannulated Screws
K150126 · HWC
Life Spine, Inc.
Orthopedic · 111d
Cleared May 11, 2015
The Octane Straight Intervertebral Fusion Device, Ti Coated
K150152 · MAX
Exactech, Inc.
Orthopedic · 108d
Cleared May 11, 2015
Magic3 Go Intermittent Urinary Catheter
K150345 · EZD
C.R. Bard, Inc.
Gastroenterology & Urology · 89d
Cleared May 09, 2015
Terason uSmart3200T Ultrasound System
K150533 · IYN
Teratech Corp.
Radiology · 68d
Cleared May 08, 2015
DERMAFINE
K140905 · FRO
Invado Pharmaceuticals
General & Plastic Surgery · 394d
Cleared May 08, 2015
CUFF PILOT, SURE SEAL
K142103 · BSK
Teleflexmedical, Inc.
Anesthesiology · 280d
Cleared May 08, 2015
Stryker Footed Attachments and Cutting Accessories
K143399 · HBE
Stryker Corp.
Neurology · 161d
Cleared May 08, 2015
AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze...
K143462 · QSY
Benq Materials Corporation
General & Plastic Surgery · 155d
Cleared May 08, 2015
Rapid Therapy System
K143531 · OBP
Magstim Company Limited
Neurology · 147d
Cleared May 08, 2015
MultiBand SENSE
K143606 · LNH
Philips Medical Systems Nethrlands BV
Radiology · 140d
Cleared May 08, 2015
Aspen Laser Systems Therapy Laser System
K150138 · PDZ
Aspen Laser Systems, LLC
General & Plastic Surgery · 106d
Cleared May 08, 2015
Subtalar Spacer System (STS)
K150213 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 98d
Cleared May 08, 2015
ORTHOPHOS SL
K150217 · OAS
Sirona Dental Systems GmbH
Radiology · 98d
Cleared May 08, 2015
MedSource Sharps Dart
K150333 · MMK
Medsource International, LLC
General Hospital · 87d
Cleared May 08, 2015
Touch Ultrasound
K150342 · IYO
Carestream Health, Inc.
Radiology · 86d
Cleared May 08, 2015
Level Sensor, Level Sensor Tape
K150530 · DTW
Medtronic, Inc.
Cardiovascular · 67d
Cleared May 08, 2015
740 SELECT
K150620 · MWI
Cas Medical Systems, Inc.
Cardiovascular · 59d
Cleared May 08, 2015
VariSeed 9.0
K150636 · KXK
Varian Medical Systems, Inc.
Radiology · 58d
Cleared May 08, 2015
VitalBeam
K150706 · IYE
Varian Medical Systems, Inc.
Radiology · 51d
Cleared May 08, 2015
Snap-Off Self-Compressive Screw
K150772 · HWC
Neosteo
Orthopedic · 45d
Cleared May 08, 2015
Jumong Series
K150816 · KPR
Sg Healthcare Co, Ltd.
Radiology · 42d