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
38545–38568 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 04, 2014
MEDINAUT KYPHOPLASTY SYSTEM
K133669 · NDN
Imedicom
Orthopedic · 126d
Cleared Apr 04, 2014
TORNIER INSITE(TM) FT PEEK KNOTLESS SUTURE ANCHOR
K133777 · MBI
Tornier, Inc.
Orthopedic · 113d
Cleared Apr 04, 2014
TRIBALL INCENTIVE SPIROMETER
K133873 · BWF
Besmed Health Business Corp
Anesthesiology · 105d
Cleared Apr 04, 2014
NORDICBRAINEX
K133910 · LLZ
Nordicneurolab
Radiology · 102d
Cleared Apr 04, 2014
ARTUS C. DIFFICILE QS-RGQ MDX KIT
K133936 · OZN
QIAGEN GmbH
Microbiology · 102d
Cleared Apr 04, 2014
TSP HIP FRACTURE PLATING SYSTEM
K140018 · JDO
Biomet, Inc.
Orthopedic · 91d
Cleared Apr 04, 2014
US ENDOSCOPY DISTAL ATTACHMENT CAP
K140315 · OCX
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 53d
Cleared Apr 04, 2014
8MP COLOR LCD MONITOR, RADIFORCE RX850
K140702 · PGY
Eizo Corporation
Radiology · 15d
Cleared Apr 03, 2014
KOBOLD SECURE LOCK TRANSFER GUIDE TUBE SET
K130757 · JAQ
Spencer Fillmore
Radiology · 379d
Cleared Apr 03, 2014
MEDICALYTE(R) BICARBONATE POWDER (36.83X), MEDICALYTE(R) BICARBONATE POWDER...
K131202 · KPO
Dialysis Medical Solutions, LLC
Gastroenterology & Urology · 339d
Cleared Apr 03, 2014
FLEXIBLE COOAGEN NERVE CUFF
K131541 · JXI
Collagen Matrix, Inc.
Neurology · 309d
Cleared Apr 03, 2014
PERCLOT TOPICAL
K132105 · QSY
Cryolife, Inc.
General & Plastic Surgery · 269d
Cleared Apr 03, 2014
VITALCONNECT PLATFORM BY VITAL CONNECT INC.
K132447 · DRG
Vitalconnect, Inc.
Cardiovascular · 240d
Cleared Apr 03, 2014
ZOLL CODE WRITER
K132488 · DXJ
ZOLL Medical Corporation
Cardiovascular · 238d
Cleared Apr 03, 2014
ACUITY PRO LEAD DELIVERY SYSTEM
K132914 · DQY
Boston Scientific
Cardiovascular · 198d
Cleared Apr 03, 2014
VIZION ULTRA
K133139 · MQB
Viztek, LLC
Radiology · 168d
Cleared Apr 03, 2014
ALEUTIAN IBF SYSTEM
K133614 · MAX
K2m, Inc.
Orthopedic · 129d
Cleared Apr 03, 2014
DEPUY GLOBAL UNITE SHOULDER SYSTEM
K133834 · KWS
Depuy(Ireland)
Orthopedic · 107d
Cleared Apr 03, 2014
VERISUITE 1.8, VERISUITE-PARTICLE 1.8, VERISUITE, VERISUITE-PARTICLE
K133914 · LHN
Medcom GmbH
Radiology · 101d
Cleared Apr 03, 2014
COROENT SMALL INTERBODY SYSTEM
K140003 · ODP
Nuvasive, Inc.
Orthopedic · 91d
Cleared Apr 03, 2014
DYNASTY SHELL, DYNASTY A-CLASS CROSSLINKED POLY LINER, BIOLOX DELTA FEMORAL HEAD
K140043 · LZO
Microport Orthopedics, Inc.
Orthopedic · 85d
Cleared Apr 03, 2014
CRYOTOP(R) SC
K140072 · MQK
Kitazato Biopharma Co;Ltd
Obstetrics & Gynecology · 80d
Cleared Apr 03, 2014
SUB-Q SUBCUTANEOUS TISSUE INFUSION SET
K140131 · FPA
Emed Technologies Corporation
General Hospital · 76d
Cleared Apr 03, 2014
VARIAX 2 SYSTEM
K140376 · HRS
Stryker Trauma AG
Orthopedic · 48d