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
38569–38592 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 03, 2014
MEDSOURCE IV ADMINISTRATION SET 72 MEDSOURCE IV ADMINISTRATION SET,...
K140402 · LHI
Medsource International, LLC
General Hospital · 44d
Cleared Apr 03, 2014
MACH LED 2SC
K140460 · FSY
Dr. Mach GmbH & Co. KG
General & Plastic Surgery · 38d
Cleared Apr 03, 2014
MACH LED 2MC
K140461 · FSY
Dr. Mach GmbH & Co. KG
General & Plastic Surgery · 38d
Cleared Apr 02, 2014
AHP 300, EMERGENCY PORTABLE VENTILATOR
K132021 · BTL
Allied Healthcare Products, Inc.
Anesthesiology · 274d
Cleared Apr 02, 2014
INNESIS PEEK CERVICAL CAGE
K132483 · ODP
Bk Meditech, Co., Ltd.
Orthopedic · 237d
Cleared Apr 02, 2014
INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER
K133933 · KNS
Boston Scientific Corporation
Gastroenterology & Urology · 100d
Cleared Apr 02, 2014
SIGNATURE PLANNER, SIGNATURE GUIDES
K140257 · MBH
Materialise NV
Orthopedic · 58d
Cleared Apr 01, 2014
OMNYX IDP FOR HER2 MANUAL APPLICATION
K131140 · OEO
Omnyx, LLC
Pathology · 344d
Cleared Apr 01, 2014
N8TIVE ACL ANATOMIC RECONSTRUCTION SYSTEM, N8TIVE ACL FEMORAL IMPLANT, N8TIVE...
K133606 · MBI
ArthroCare Corporation
Orthopedic · 127d
Cleared Apr 01, 2014
MODIFIED DISTAL RADIUS PLATING SYSTEM
K133939 · HRS
Biomet
Orthopedic · 99d
Cleared Apr 01, 2014
VUPAD
K140199 · IYO
Sonomed, Inc.
Radiology · 64d
Cleared Apr 01, 2014
VARIAX CLAVICLE HOOK PLATE
K140259 · HRS
Stryker Trauma AG
Orthopedic · 57d
Cleared Apr 01, 2014
TABLET VIEWER SOFTWARE FOR IMAGE SUITE
K140271 · LLZ
Carestream Health, Inc.
Radiology · 57d
Cleared Apr 01, 2014
IMBIBE NEEDLE
K140414 · LXH
Orthovita, Inc.
Orthopedic · 42d
Cleared Apr 01, 2014
VADO STEERABLE SHEATH
K140420 · DYB
Kalila Medical, Inc.
Cardiovascular · 42d
Cleared Apr 01, 2014
IMMULITE 2000: C-PEPTIDE CALIBRATION VERIFICATION MATERIAL, SHBG CALIBRATION...
K140541 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 28d
Cleared Mar 31, 2014
VASHE WOUND SOLUTION (4.0 OZ), (8.5 OZ & (16.0 OZ)
K131848 · FRO
Puricore, Inc.
General & Plastic Surgery · 283d
Cleared Mar 31, 2014
SYNTHES SYNSONIC ULNA NAIL
K131984 · HSB
Synthes (Usa)
Orthopedic · 276d
Cleared Mar 31, 2014
BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST...
K132850 · GXQ
Rti Surgical, Inc.
Neurology · 201d
Cleared Mar 31, 2014
INFILL 41-TLIF CONVEX OBLIQUE DEVICE, INFILL 43-TLIF CONTOUR OBLIQUE, INFILL...
K133721 · MAX
Pinnacle Spine Group, LLC
Orthopedic · 116d
Cleared Mar 31, 2014
MIROMATRIX BIOLOGICAL MESH
K134033 · FTM
Miromatrix Medical, Inc.
General & Plastic Surgery · 90d
Cleared Mar 31, 2014
EP-TRACER SYSTEM, EP-TRACER SYSTEM, EP-TRACER SYSTEM
K134044 · DQK
Cardio Tek, BV
Cardiovascular · 90d
Cleared Mar 31, 2014
ADVIA CENTAUR VITAMIN B12 MASTER CURVE MATERIAL, TOTAL HCG MASTER CURVE...
K140505 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 32d
Cleared Mar 31, 2014
ICEROD CX CRYOABLATION NEEDLE
K140584 · GEH
Galil Medical , Ltd.
General & Plastic Surgery · 24d