FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
84673–84696 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 02, 1999
SAGE CONTRAST MANAGEMENT SYSTEM
K991112 · FPA
Sage Laboratories, Inc.
General Hospital · 154d
Cleared Sep 02, 1999
ASTOTHERM PLUS, ASTOTUBES, ASTOLINE
K991160 · BSB
Stihler Electronic GmbH
Hematology · 148d
Cleared Sep 02, 1999
MAGNESIUM PRODUCT NO'S, 112-01, 112-02
K991761 · JGJ
A.P. Total Care, Inc.
Chemistry · 101d
Cleared Sep 02, 1999
ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02
K991762 · CJE
A.P. Total Care, Inc.
Chemistry · 101d
Cleared Sep 02, 1999
SOOTHE-N-SEAL CANKER SORE RELIEF
K991923 · MZW
Closure Medical Corp.
Dental · 87d
Cleared Sep 02, 1999
DR. B'S MOUTHPIECE, MODEL 32129-10002
K991948 · LRK
Snore - Ezzer
Dental · 85d
Cleared Sep 02, 1999
LYPHOCHEK TUMOR MARKER CONTROL, MODEL 580
K992172 · JJY
Bio-Rad
Chemistry · 66d
Cleared Sep 02, 1999
DRUGCHECK X MULTIDRUG SCREENING DEVICE
K992748 · DIO
Syntron Bioresearch, Inc.
Toxicology · 17d
Cleared Sep 01, 1999
PDM3 DISINFECTION SYSTEM FOR PERITONEAL DIALYSIS EXCHANGES, PATIENT TRANSFER...
K974387 · KDJ
Microwave Medical Systems, Inc.
Gastroenterology & Urology · 649d
Cleared Sep 01, 1999
NIBP AND CO2 OPTIONS FOR THE PHYSIO-CONTROL LIFEPAK 12 DEFIBRILLATOR/MONITOR...
K990338 · DXN
Physio-Control Corp.
Cardiovascular · 210d
Cleared Sep 01, 1999
CUFF-ABLE PLUS
K990412 · DXQ
Vital Signs, Inc.
Cardiovascular · 203d
Cleared Sep 01, 1999
INTRASTENT II
K990592 · FGE
Intratherapeutics, Inc.
Gastroenterology & Urology · 189d
Cleared Sep 01, 1999
DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE
K990873 · JMT
Ameritek, Inc.
Chemistry · 169d
Cleared Sep 01, 1999
NIHON KOHDEN MEB-2200A NEUROPACK EVOKED POTENTIAL & EMG MEASURING SYSTEM WITH...
K991899 · GWF
Nihon Kohden America, Inc.
Neurology · 89d
Cleared Sep 01, 1999
COROMETRICS MODEL 171 AND 172 FETAL MONITOR
K991905 · HGM
General Electric Medical Systems...
Obstetrics & Gynecology · 89d
Cleared Sep 01, 1999
DIGITAL IMAGING SYSTEM (BSR)
K991922 · IZI
Siemens Medical Solutions USA, Inc.
Radiology · 86d
Cleared Sep 01, 1999
PATTON SPECULUM
K991963 · HIB
Patton Medical Corp.
Obstetrics & Gynecology · 83d
Cleared Sep 01, 1999
VANTAGE EXSPECT II
K992078 · KPS
Adac Laboratories
Radiology · 75d
Cleared Sep 01, 1999
C-QUEST
K992103 · OWB
Wuestec Medical, Inc.
Radiology · 71d
Cleared Sep 01, 1999
CORE POUCH
K992190 · GCJ
Core Dynamics, Inc.
General & Plastic Surgery · 64d
Cleared Sep 01, 1999
REUNITE SCREWS
K992301 · HWC
Biomet Manufacturing, Inc.
Orthopedic · 55d
Cleared Sep 01, 1999
ENDIUS SUCTION/IRRIGATION INSTRUMENT
K992535 · OCX
Endius, Inc.
Gastroenterology & Urology · 34d
Cleared Sep 01, 1999
TM-300 TRACTION SYSTEM
K992545 · ITH
Ito Co., Ltd.
Physical Medicine · 33d
Cleared Sep 01, 1999
UNITRAX C-TAPER NECK ADJUSTMENT SLEEVE
K992570 · KWL
Howmedica Osteonics Corp.
Orthopedic · 30d