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
61921–61944 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 18, 2006
CORONIS 2MP AND MDCG 2121 - CB
K061926 · LLZ
Barcoview
Radiology · 42d
Cleared Aug 18, 2006
HHF1 ECHELON MULTI-PURPOSE COIL
K061950 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 39d
Cleared Aug 18, 2006
7F ACUMEN CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS-7-67
K062084 · DQY
Acumen Medical, Inc.
Cardiovascular · 28d
Cleared Aug 18, 2006
SECURVIEW DX DIAGNOSTIC WORKSTATION, MODELS SV-0001, SV-0002 AND SV-0003
K062107 · LLZ
Hologic, Inc.
Radiology · 25d
Cleared Aug 18, 2006
DELTA CTA REVERSE SHOULDER SYSTEM HUMERAL HEADS
K062116 · PHX
DePuy Orthopaedics, Inc.
Orthopedic · 24d
Cleared Aug 18, 2006
CONTRAST DELIVERY SYSTEM - DUAL SHOT ALPHA
K062168 · DXT
Nemoto Kyorindo Co., Ltd.
Cardiovascular · 18d
Cleared Aug 18, 2006
HD11 DIAGNOSTIC ULTRASOUND SYSTEM
K062247 · IYN
Philips Ultrasound, Inc.
Radiology · 15d
Cleared Aug 18, 2006
REFLEX HYBRID ACP SYSTEM
K062310 · KWQ
Stryker Spine
Orthopedic · 10d
Cleared Aug 17, 2006
ZOLL R SERIES DEFIBRILLATOR
K060559 · MKJ
ZOLL Medical Corporation
Cardiovascular · 168d
Cleared Aug 17, 2006
TIGRIS DTS GEN-PROBE APTIMA COMBO 2 ASSAY
K060652 · LSL
Gen-Probe, Inc.
Microbiology · 157d
Cleared Aug 17, 2006
MICROSELECTRON V3, MODEL 106.990
K061354 · JAQ
Nucletron Corporation
Radiology · 94d
Cleared Aug 17, 2006
SYDNEY IVF SPERM CRYOPRESERVATION BUFFER
K061371 · MQL
Cook Urological, Inc.
Obstetrics & Gynecology · 92d
Cleared Aug 17, 2006
BONART ART-P3II & P4 PIEZO ELECTRIC ULTRASONIC SCALER UNITS WITH ACCESSORIES
K061448 · ELC
Bonart Co., Ltd.
Dental · 87d
Cleared Aug 17, 2006
XAMINER
K061595 · KPR
Imaging Dynamics Company , Ltd.
Radiology · 70d
Cleared Aug 17, 2006
PEDI-SPIDER STRAP
K061721 · NZD
Emergency Products and Research
General Hospital · 59d
Cleared Aug 17, 2006
DARCO LOCKING BONE PLATE SYSTEM
K061808 · HRS
Darco International, Inc.
Orthopedic · 51d
Cleared Aug 17, 2006
SIEMENS ACUSON X500 ULTRASOUND SYSTEM
K061980 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 35d
Cleared Aug 17, 2006
RESPCARE HYBRID NE FACE MASK, MODEL TBD,
K062019 · CBK
Innomed Technologies, Inc./Respcare,...
Anesthesiology · 31d
Cleared Aug 17, 2006
CXDI-40EC
K062221 · MQB
Canon, Inc.
Radiology · 15d
Cleared Aug 17, 2006
RESPCARE HYBRID AV MASK
K062224 · BZD
Respcare, Inc.
Anesthesiology · 15d
Cleared Aug 17, 2006
AZURYT MODEL CTL 1401, CO2 SURGICAL LASER SYSTEM
K062248 · GEX
North American Clinical Lasers, Ltd.
General & Plastic Surgery · 14d
Cleared Aug 16, 2006
ACUBAND ACUPRESSURE WRIST BAND DEVICE
K053509 · MVV
Acuband, Inc.
Neurology · 243d
Cleared Aug 16, 2006
ABX PENTRA BILIRUBIN, DIRECT CP, ABX PENTRA BILIRUBIN, TOTAL CP, ABX PENTRA...
K060325 · CIG
Horiba Abx
Chemistry · 188d
Cleared Aug 16, 2006
INTRALASE FS LASER, INTRALASE FS30 LASER, MODELS 1, 2, 3
K060372 · GEX
Intra Lase Corp.
General & Plastic Surgery · 184d