FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
78721–78744 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 12, 2001
INTERSTRAND 125 & INTERSTRAND 103, MODEL NUMBERS 1251S AND 1031S
K011155 · KXK
Ibt, Inc.
Radiology · 87d
Cleared Jul 12, 2001
TEMPORALSCANNER THERMOMETER, SENSORTOUCH
K011291 · FLL
Exergen Corp.
General Hospital · 76d
Cleared Jul 12, 2001
MEDTRONIC COLVIN-GALLOWAY FUTURE ANNULOPLASTY BAND, MODEL 638B
K011395 · KRH
Medtronic Vascular
Cardiovascular · 66d
Cleared Jul 12, 2001
PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS
K011557 · DXF
NuMED, Inc.
Cardiovascular · 52d
Cleared Jul 12, 2001
TRUBYTE DENTURE BASE RESIN SYSTEM
K011560 · EBI
Dentsply Intl.
Dental · 52d
Cleared Jul 12, 2001
PURESPERM BUFFER
K011606 · MQL
Nidacon International AB
Obstetrics & Gynecology · 49d
Cleared Jul 12, 2001
VACUETTE SAFETY BLOOD COLLECTION SET
K011786 · FMI
Greiner Vacuette North America, Inc.
General Hospital · 34d
Cleared Jul 12, 2001
DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT
K011862 · KPM
Denver Biomedical, Inc.
Gastroenterology & Urology · 28d
Cleared Jul 12, 2001
LIQUID ASSAYED MULTIQUAL CONTROL LEVEL1 #981600
K011867 · JJY
Bio-Rad
Chemistry · 28d
Cleared Jul 12, 2001
HYPODERMIC NEEDLE-PRO NEEDLE WITH NEEDLE PROTECTION DEVICE
K011925 · FMI
Sims Portex, Inc.
General Hospital · 22d
Cleared Jul 12, 2001
VARISEED 7.0
K012017 · MUJ
Varian Medical Systems
Radiology · 14d
Cleared Jul 12, 2001
VOXAR VC, MODEL 1.0
K012072 · LLZ
Voxar Limited
Radiology · 10d
Cleared Jul 12, 2001
VORTEX
K012097 · LLZ
Ultravisual Medical Systems
Radiology · 7d
Cleared Jul 12, 2001
PROTON THERAPY SYSTEM
K983024 · LHN
Ion Beam Applications S.A.
Radiology · 1046d
Cleared Jul 11, 2001
MACROPOREPX PEDIATRIC SYSTEM
K002207 · JEY
Macropore Biosurgery, Inc.
Dental · 355d
Cleared Jul 11, 2001
VENOUS HARDSHELL CARDIOTOMY RESEVOIR, MODEL VHK 4201
K003551 · DTN
Jostra AG
Cardiovascular · 236d
Cleared Jul 11, 2001
SCS DT-02 TRANSVERSE CONNECTOR
K003823 · KWP
Ortho Tec, LLC
Orthopedic · 212d
Cleared Jul 11, 2001
SIGN IM NAIL
K011129 · HSB
Sign, Inc.
Orthopedic · 89d
Cleared Jul 11, 2001
TELEPAX
K011173 · LLZ
Imed Systems & Consulting, LLC
Radiology · 85d
Cleared Jul 11, 2001
DEVILBISS 9000 SERIES CPAP, MODEL 9001
K011229 · BZD
Sunrise Medical Hhg, Inc.
Anesthesiology · 79d
Cleared Jul 11, 2001
RECTOSIGHT RS300-04
K011825 · FER
Sightline Technologies , Ltd.
Gastroenterology & Urology · 30d
Cleared Jul 11, 2001
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS...
K011851 · DQA
Masimo Corp.
Anesthesiology · 28d
Cleared Jul 11, 2001
MODIFIED M-IV MAMMOGRAPHY SYSTEM
K011987 · IZH
Lorad, A Hologic Co.
Radiology · 15d
Cleared Jul 10, 2001
POWDER FREE LATEX EXAMINATION GLOVES
K010546 · LYY
Jb Star Sdn Bhd
General Hospital · 137d