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
79513–79536 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 22, 2001
TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING
K010920 · HEL
Medical Cables, Inc.
Obstetrics & Gynecology · 87d
Cleared Jun 22, 2001
THE NIMBLE ROCKET POWERED WHEELCHAIR
K010941 · ITI
Nimble, Inc.
Physical Medicine · 85d
Cleared Jun 22, 2001
AMS SLING FIXATION SYSTEM
K010990 · GAW
American Medical Systems, Inc.
General & Plastic Surgery · 80d
Cleared Jun 22, 2001
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
K011015 · NFK
C.R. Bard, Inc.
Gastroenterology & Urology · 79d
Cleared Jun 22, 2001
TAUT BALLOON CATHETER, MODEL 50640
K011018 · GCA
Taut, Inc.
Gastroenterology & Urology · 79d
Cleared Jun 22, 2001
NEUROGEN NERVE GUIDE
K011168 · JXI
Integra Lifesciences Corp.
Neurology · 66d
Cleared Jun 22, 2001
AUTOMATED CORE BIOPSY DEVICE
K011270 · FCG
Promex, Inc.
Gastroenterology & Urology · 57d
Cleared Jun 22, 2001
LUTE VLC
K011309 · EBF
First Scientific Limited
Dental · 53d
Cleared Jun 22, 2001
JP CAST 50
K011330 · EJT
Jeneric/Pentron, Inc.
Dental · 51d
Cleared Jun 22, 2001
JP CAST 40
K011331 · EJT
Jeneric/Pentron, Inc.
Dental · 51d
Cleared Jun 22, 2001
HMT 21, HMT 2000 URINARY INCONTINENCE SYSTEM
K011435 · KPI
Hmt, Inc.
Gastroenterology & Urology · 43d
Cleared Jun 22, 2001
MEDTRONIC SPINAL CORD STIMULATION AND PERIPHERAL NERVE STIMULATION SYSTEMS...
K011584 · GZB
Medtronic Vascular
Neurology · 30d
Cleared Jun 22, 2001
MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM
K011612 · FQH
Hydrocision, Inc.
General Hospital · 28d
Cleared Jun 22, 2001
THE AUTOTAC SYSTEM
K011675 · DZL
BioHorizons Implant Systems, Inc.
Dental · 23d
Cleared Jun 22, 2001
MEDLITE Q-SWITCHED ND:YAG LASER REPLACED BY THE MEDLITE C3 Q-SWTICHED ND:YAG...
K011677 · GEX
Continuum Electro-Optics, Inc.
General & Plastic Surgery · 23d
Cleared Jun 22, 2001
BIOTECH MANUAL WHEELCHAIR C650 SERIES TOUR LIGHT WHEELCHAIR
K011701 · IOR
Taiwan Armada Enterprise Co., Ltd.
Physical Medicine · 21d
Cleared Jun 22, 2001
STRYKER T4 HYTREL (R) TOGAS
K011755 · LYU
Stryker Corp.
General Hospital · 16d
Cleared Jun 22, 2001
DORNIER LITHOTRIPTER 140(DOLI 140)
K011773 · LNS
Dornier
Gastroenterology & Urology · 15d
Cleared Jun 22, 2001
PROCEDURE MASKS: PM4-301 AND PM4-304
K011789 · FXX
Primeline Medical Products, Inc.
General Hospital · 14d
Cleared Jun 21, 2001
DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100, DADE PFA...
K002885 · JOZ
Dade Behring, Inc.
Hematology · 279d
Cleared Jun 21, 2001
EMBOGOLD MICROSPHERE
K010026 · HCG
Biosphere Medical, Inc.
Neurology · 169d
Cleared Jun 21, 2001
FOX PTA CATHETER, 3.0, 4.0, 5.0, 6.0, 7.0, AND 8.0 X 40 MM, MODELS A14003,...
K010838 · DQY
Jomed AG
Cardiovascular · 93d
Cleared Jun 21, 2001
6F MACH 1, MODEL 34356-XXX
K010874 · DQY
Boston Scientific Corp
Cardiovascular · 90d
Cleared Jun 21, 2001
HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL)
K011389 · JCM
Canterbury Health Laboratories
Hematology · 45d