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
62881–62904 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 08, 2006
S. AUREUS PNA FISH
K060099 · NXX
Advandx, Inc.
Microbiology · 115d
Cleared May 08, 2006
CONDYLAFORM II NFC
K060565 · ELM
Ivoclar Vivadent, Inc.
Dental · 66d
Cleared May 08, 2006
SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVE-POWDER FREE
K060786 · LYZ
Ever Light Plastic Products Co., Ltd.
General Hospital · 47d
Cleared May 05, 2006
NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, MODEL NWS05
K051760 · DXX
Stereotaxis, Inc.
Cardiovascular · 310d
Cleared May 05, 2006
ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST
K053035 · DIO
Acro Biotech, LLC
Toxicology · 190d
Cleared May 05, 2006
HOMMED CENTRAL STATION, VERSION 3.5
K053453 · DXN
Honeywell Hommed, LLC
Cardiovascular · 144d
Cleared May 05, 2006
OMI RETRACTABLE SAFETY SYRINGE
K060109 · MEG
Vitalcare Group, Inc.
General Hospital · 112d
Cleared May 05, 2006
NODECREST TRANSCRANICAL DOPPLER ULTRASOUND SYSTEM
K060112 · IYN
Nodecrest, LLC
Radiology · 108d
Cleared May 05, 2006
INFREX
K060246 · GZJ
Johari Digital Healthcare , Ltd.
Neurology · 94d
Cleared May 05, 2006
GLUCOSE
K060383 · CFR
Abbott Laboratories
Chemistry · 80d
Cleared May 05, 2006
INTRODUCER ASSEMBLY WITH ROTATOR LOCK
K060519 · DYB
Teleflex Medical
Cardiovascular · 67d
Cleared May 05, 2006
ASCENSION PYROSPHERE CMC/TMT
K060560 · KWD
Ascension Orthopedics, Inc.
Orthopedic · 64d
Cleared May 05, 2006
OR HEAD COIL 1.5 T
K060758 · MOS
Siemens Medical Solutions USA, Inc.
Radiology · 45d
Cleared May 05, 2006
MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM
K060957 · DZE
Blue Sky Bio, LLC
Dental · 28d
Cleared May 05, 2006
RELIENT NAVIGATION DEVICE
K060974 · KAM
Acclarent, Inc.
General & Plastic Surgery · 25d
Cleared May 04, 2006
DEPILITE EL-8B SERIES DERMO FLASH SYSTEMS
K052371 · GEX
Hair International Systems USA, Inc.
General & Plastic Surgery · 247d
Cleared May 04, 2006
HOT DOG PATIENT WARMING SYSTEM
K052392 · DWJ
Augustine Biomedical & Design, LLC
Cardiovascular · 246d
Cleared May 04, 2006
STA-CEPHASCREEN KIT
K053111 · GFO
Diagnostica Stago, Inc.
Hematology · 181d
Cleared May 04, 2006
REPROCESSED BALOON INFLATION DEVICE
K053188 · NKU
Sterilmed, Inc.
Cardiovascular · 170d
Cleared May 04, 2006
PM-9000 EXPRESS PATIENT MONITOR
K053234 · MWI
Shenzhen Mindray Bio-Medical...
Cardiovascular · 167d
Cleared May 04, 2006
SONICATOR 740, MODEL ME 740
K053546 · IMI
Mettler Electronics Corp.
Physical Medicine · 135d
Cleared May 04, 2006
CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER...
K060065 · DQA
Oridion Capnography, Inc.
Anesthesiology · 115d
Cleared May 04, 2006
IGS VAGINAL SPECULUM
K060129 · HIB
Innovative Gynecological Solutions, LLC
Obstetrics & Gynecology · 106d
Cleared May 04, 2006
SPIRALOK ANCHOR
K060271 · HWC
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 92d