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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
62185–62208 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 21, 2006
NOMOSSTAT, VERSION 1.0
K060895 · IYE
Nomos Corp.
Radiology · 109d
Cleared Jul 21, 2006
QMS TOBRAMYCIN
K060998 · LCR
Seradyn, Inc.
Chemistry · 101d
Cleared Jul 21, 2006
VERESURE BELL
K061387 · HIF
Veresure, Inc.
Obstetrics & Gynecology · 64d
Cleared Jul 21, 2006
QUANTIVA
K061418 · LLZ
Tomographix IP , Ltd.
Radiology · 60d
Cleared Jul 21, 2006
5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MDL2116A (ME551I2)
K061447 · LLZ
Totoku Electric Co., Ltd.
Radiology · 57d
Cleared Jul 21, 2006
MD-TEMP
K061530 · EBG
Meta Biomed Co., Ltd.
Dental · 49d
Cleared Jul 21, 2006
AMEDICA DRUG SCREEN THC, COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,
K061556 · LDJ
Amedica Biotech, Inc.
Toxicology · 46d
Cleared Jul 21, 2006
COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632
K061574 · GKZ
Beckman Coulter, Inc.
Hematology · 44d
Cleared Jul 21, 2006
VITROS CHEMISTRY PRODUCTS HCY REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR...
K061588 · LPS
Ortho-Clinical Diagnostics, Inc.
Chemistry · 43d
Cleared Jul 21, 2006
TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM
K061683 · DDR
Roche Diagnostics Corp.
Chemistry · 36d
Cleared Jul 21, 2006
MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS
K061687 · JWY
Dade Behring, Inc.
Microbiology · 36d
Cleared Jul 21, 2006
MAGIS1
K061713 · IYE
Direx Systems Corp.
Radiology · 32d
Cleared Jul 21, 2006
VENOUS HARDSHELL CARDIOTOMY RESERVOIR W/SAFELINE COATING, MODEL BSQ-VHK 2000
K061743 · DTN
Maquet Cardiopulmonary, AG
Cardiovascular · 30d
Cleared Jul 21, 2006
ADMIRA PROTECT/ADMIRA PROTECT SINGLE DOSE
K061823 · EBC
Voco GmbH
Dental · 23d
Cleared Jul 21, 2006
ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM
K061946 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 11d
Cleared Jul 21, 2006
PREFORMANCE POSTS AND TEMPORARY CYLINDERS
K061969 · NHA
Implant Innovations, Inc.
Dental · 9d
Cleared Jul 21, 2006
PELEX-04 WIRELESS ELECTROCARDIOGRAPH WITH SOFTWARE ACCESSORIES
K061977 · DXH
Pinmed, Inc.
Cardiovascular · 8d
Cleared Jul 20, 2006
TCS UNBREAKABLE
K053060 · EBI
Thermoplastic Comfort Systems, Inc.
Dental · 262d
Cleared Jul 20, 2006
M-COR HIP REPLACEMENT SYSTEM
K053417 · LPH
Portland Orthopaedics Pty. , Ltd.
Orthopedic · 224d
Cleared Jul 20, 2006
RANDOX LIQUID PROTEIN CALIBRATOR
K061056 · JIX
Randox Laboratories, Ltd.
Immunology · 94d
Cleared Jul 20, 2006
PRESTIGE CPAP FLOW GENERATOR WITH PRESTIGE HUMIDIFIER
K061200 · BZD
Resmed, Ltd.
Anesthesiology · 80d
Cleared Jul 20, 2006
REVERE STABILIZATION SYSTEM
K061202 · NKB
Globus Medical, Inc.
Orthopedic · 80d
Cleared Jul 20, 2006
EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3
K061376 · MOB
Theratest Laboratories, Inc.
Immunology · 64d
Cleared Jul 20, 2006
AEQUALIS REVERSED PROSTHESIS
K061439 · PHX
Tornier
Orthopedic · 57d