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

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176,076 results
65905–65928 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 19, 2005
ADAPTER CABLE
K050884 · DTA
Remington Medical, Inc.
Cardiovascular · 42d
Cleared May 19, 2005
FUJINON G5 BRONCHOSCOPES, MODELS EB-470S, EB-250S, AND EB-270P
K050907 · EOQ
Fujinon, Inc.
Ear, Nose, Throat · 38d
Cleared May 19, 2005
FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICE
K051000 · MQP
Spinal Concepts, Inc.
Orthopedic · 29d
Cleared May 19, 2005
HOSPIRA GEMSTAR INFUSION PUMP SYSTEM WITH HOSPIRA GEMSTAR SPRING ASSIST...
K051079 · MRZ
Hospicare, Inc.
General Hospital · 22d
Cleared May 19, 2005
CARDIOSCOPE SONOPLUS 3000
K051126 · DPS
Pulsonic Ag, Medical Technology
Cardiovascular · 16d
Cleared May 19, 2005
INOVEL HEALTH CARE MODEL N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS
K051182 · MSH
Inovel, LLC
General Hospital · 10d
Cleared May 18, 2005
BIOPRO TARA FEMORAL RESURFACING COMPONENT
K043542 · KXA
Biopro, Inc.
Orthopedic · 146d
Cleared May 18, 2005
LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER
K050168 · DQO
Vascular Solutions, Inc.
Cardiovascular · 112d
Cleared May 18, 2005
SYNTHES CARNIOFACIAL PLATE AND SCREW SYSTEM
K050608 · JEY
Synthes (Usa)
Dental · 69d
Cleared May 18, 2005
STRYKER DISCMONITOR
K050753 · FMF
Stryker Instruments
General Hospital · 56d
Cleared May 18, 2005
PRECIMED CANNULATED SCREW SYSTEM
K050754 · HWC
Precimed, Inc.
Orthopedic · 56d
Cleared May 18, 2005
ANS SCS ACCESSORY KIT
K050922 · GZB
Advanced Neuromodulation Systems
Neurology · 35d
Cleared May 18, 2005
LIGHTWAVE INTEGRATED ELECTRODE ABLATOR AND LIGHT WAVE INTEGRATED ELECTRODE...
K050923 · JOS
Conmed Linvatec
General & Plastic Surgery · 35d
Cleared May 18, 2005
PUREVISION MULTI-FOCAL (BALAFILCON A) VISIBILITY TINTED CONTACT LENS
K050948 · LPL
Bausch & Lomb, Inc.
Ophthalmic · 33d
Cleared May 18, 2005
EUTROCHAR
K050957 · MDM
Special Devices, Inc.
General & Plastic Surgery · 33d
Cleared May 18, 2005
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
K051153 · LYZ
Hebei Manful Import & Export Co., Ltd.
General Hospital · 14d
Cleared May 17, 2005
EPI-MAX
K041059 · FRO
Dermagenics, Inc.
General & Plastic Surgery · 389d
Cleared May 17, 2005
IPLAN! DIGITAL TEMPLATING
K042543 · HAW
Brainlab AG
Neurology · 239d
Cleared May 17, 2005
DERMACYN WOUND IRRIGATION
K042729 · FRO
Oculus Innovative Sciences, Inc.
General & Plastic Surgery · 228d
Cleared May 17, 2005
INTERX5000
K042912 · GZJ
Neuro Resource Group, Inc.
Neurology · 208d
Cleared May 17, 2005
THEKEN REVEAL VBR SYSTEM
K050058 · MQP
Theken Surgical,Llc
Orthopedic · 126d
Cleared May 17, 2005
NEXGEN COMPLETE KNEE SOLUTION DISTAL FEMORAL SPACERS
K050105 · JDI
Zimmer, Inc.
Orthopedic · 119d
Cleared May 17, 2005
CELLERATION MIST THERAPY SYSTEM 5.1
K050129 · NRB
Celleration, Inc.
General & Plastic Surgery · 118d
Cleared May 17, 2005
RANDOX BENZODIAZEPINE CLASS ASSAY
K050179 · JXM
Randox Laboratories, Ltd.
Toxicology · 111d