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
64201–64224 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 05, 2005
POWDER FREE LATEX STERILE PATIENT EXAMINATION GLOVES
K052728 · LYY
M/S. Kanam Latex Industries Pvt. , Ltd.
General Hospital · 67d
Cleared Dec 05, 2005
MEDIQ VERSION 1.0
K052963 · LLZ
Clario Medical Imaging, Inc.
Radiology · 45d
Cleared Dec 05, 2005
SKYLARK URO PROBE
K053007 · KPI
Skylark Device & Systems Co., Ltd.
Gastroenterology & Urology · 40d
Cleared Dec 05, 2005
SYNGO DYNAMICS, VERSION 5.0
K053133 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 27d
Cleared Dec 05, 2005
MODEL 418 SERIES WALKERS
K053192 · NXE
Mjm International Corporation
Physical Medicine · 20d
Cleared Dec 02, 2005
FOX PULSE OXIMETER
K051736 · DQA
Shunsuke Nakanishi
Anesthesiology · 157d
Cleared Dec 02, 2005
IN VISION GOLD WITH SPIN VISION, MODEL 891 SV
K052348 · IYO
Volcano Corporation
Radiology · 95d
Cleared Dec 02, 2005
SYSTEM 12 X3 ACETABULAR INSERTS
K052748 · JDI
Howmedica Osteonics Corp.
Orthopedic · 63d
Cleared Dec 02, 2005
SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP
K053105 · HSB
Synthes (Usa)
Orthopedic · 28d
Cleared Dec 02, 2005
BIOHORIZONS SINGLE-STAGE IMPLANT
K053152 · DZE
BioHorizons Implant Systems, Inc.
Dental · 22d
Cleared Dec 01, 2005
ACUMATCH M-SERIES LPB 12/14 FEMORAL STEM
K051858 · LZO
Exactech, Inc.
Orthopedic · 146d
Cleared Dec 01, 2005
POWERNEB
K051964 · NHJ
Comedica , Inc.
Anesthesiology · 134d
Cleared Dec 01, 2005
GIVEN DIAGNOSTIC SYSTEM
K052184 · NSI
Given Imaging , Ltd.
Gastroenterology & Urology · 112d
Cleared Dec 01, 2005
SERIM PERACETIC ACID CHEMICAL INDICATOR
K052388 · JOJ
Serim Research Corp.
General Hospital · 92d
Cleared Dec 01, 2005
STERILE EQUIPMENT COVERS
K052395 · KKX
Volcano Corporation
General Hospital · 92d
Cleared Dec 01, 2005
GRAFTCAGE ACX
K053080 · MQP
Osteotech, Inc.
Orthopedic · 29d
Cleared Dec 01, 2005
VITEK 2 GRAM POSITIVE TELITHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE
K053186 · LON
bioMerieux, Inc.
Microbiology · 17d
Cleared Dec 01, 2005
SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL
K053248 · BYI
Electromed, Inc.
Anesthesiology · 10d
Cleared Nov 30, 2005
GRAFTON PLUS DBM PASTE
K042707 · NUN
Osteotech, Inc.
Dental · 426d
Cleared Nov 30, 2005
MEDCOMP SPLIT CATH II
K051280 · MSD
Medcomp
Gastroenterology & Urology · 197d
Cleared Nov 30, 2005
ON-Q CATHETER, ON-ANTIMICROBIAL CATHETER, SOAKER CATHETER, I-FLOW CATHETER
K051401 · BSO
I-Flow Corp.
Anesthesiology · 183d
Cleared Nov 30, 2005
ASAHI PTCA GUIDE WIRE
K052339 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 96d
Cleared Nov 30, 2005
DAMON 3 MODIFIED
K052477 · DYW
Ormco Corp.
Dental · 82d
Cleared Nov 30, 2005
IMAGE STAR II
K052610 · JAA
Lakeshore Technologies, Inc.
Radiology · 69d