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
43777–43800 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared CT Jul 19, 2012
CORPATH 200 SYSTEM
K120834 · DXX
Corindus, Inc.
Cardiovascular · 122d
Cleared Jul 19, 2012
RSCRIBE ELECTROCARDIOGRAPH
K120865 · DPS
Mortara Instrument, Inc.
Cardiovascular · 119d
Cleared Jul 19, 2012
NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, COLORED (BLUE)
K120970 · LZA
Tangshan Zhonghong Pulin Plastic Co.,Ltd
General Hospital · 111d
Cleared Jul 19, 2012
BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM
K121270 · KZE
Bioject Medical Technologies, Inc.
General Hospital · 84d
Cleared Jul 19, 2012
CONTINUOUS SINGLE CULTURE COMPLETE
K121572 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 51d
Cleared Jul 19, 2012
MYOSURE LITE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE LITE TISSUE REMOVAL...
K121868 · HIH
Hologic, Inc.
Obstetrics & Gynecology · 23d
Cleared Jul 18, 2012
CONNECTED CARE MOBILE APPLICATION
K120325 · DRG
Watermark Medical
Cardiovascular · 167d
Cleared Jul 18, 2012
INTELLIVUE PATIENT MONITOR
K120366 · MHX
Philips Medizinsysteme Boeblingen...
Cardiovascular · 163d
Cleared Jul 18, 2012
INSUFLOW SYNERGY PORT
K120640 · HIF
Lexion Medical, LLC
Obstetrics & Gynecology · 138d
Cleared Jul 18, 2012
3.9MM REELX STT SUTURE ANCHOR SYSTEM
K120824 · MBI
Stryker Corp.
Orthopedic · 121d
Cleared Jul 18, 2012
M.U.S.T PEDICLE SCREW SYSTEM
K121115 · KWP
Medacta International
Orthopedic · 97d
Cleared Jul 18, 2012
POLARIS Q-SWITCH RUBY SYSTEM
K121162 · GEX
Sandstone Medical Technologies, LLC
General & Plastic Surgery · 92d
Cleared Jul 18, 2012
ZIO PATCH
K121319 · DSH
iRhythm Technologies, Inc.
Cardiovascular · 77d
Cleared Jul 18, 2012
MEDICREA INTERNATIONAL ANTERIOR LUMBAR PLATE
K121323 · KWQ
Medicrea International
Orthopedic · 77d
Cleared Jul 18, 2012
IO FIX, IO FIX PLUS, CARPALFIX, EXTREMITY MEDICAL SCREW AND WASHER
K121349 · HWC
Extremity Medical, LLC
Orthopedic · 75d
Cleared Jul 18, 2012
WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
K121355 · DXN
Sejoy Electronics & Instruments Co.,...
Cardiovascular · 75d
Cleared Jul 18, 2012
XMCP, HALLUX, TARSX, EXTREMITY MEDICAL SCREW SYSTEM
K121417 · HWC
Extremity Medical, LLC
Orthopedic · 68d
Cleared Jul 18, 2012
ST80I STRESS TEST SYSTEM
K121638 · DQK
Philips Health Care
Cardiovascular · 44d
Cleared Jul 18, 2012
PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM
K121671 · NKB
Zimmer Spine, Inc.
Orthopedic · 42d
Cleared Jul 18, 2012
U2 ACETABULAR CUP, PLASMA SPRAY
K121777 · LPH
United Orthopedic Corp.
Orthopedic · 30d
Cleared Jul 17, 2012
ACCU-CHECK COMBO SYSTEM
K111353 · LZG
Roche Diagnostics
General Hospital · 428d
Cleared Jul 17, 2012
FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS
K112101 · JHI
Polymed Therapeutics, Inc.
Chemistry · 361d
Cleared Jul 17, 2012
TIO2MESH TM
K113311 · FTL
Biocer Entwicklungs GmbH
General & Plastic Surgery · 251d
Cleared Jul 17, 2012
PERFORMAX PEDIATRIC EE TOTAL FACE MASK
K120562 · BZD
Respironics, Inc.
Anesthesiology · 144d