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
73945–73968 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 12, 2002
TMD SAFETY SYRINGE (FA12 SERIES 3ML/FA13 SERIES 5ML)
K022278 · MEG
Taiject Medical Device Co., Ltd.
General Hospital · 59d
Cleared Sep 12, 2002
IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,IMPAX FOR...
K022292 · LLZ
Agfa Corp.
Radiology · 59d
Cleared Sep 12, 2002
G-RINSE, MODEL 10031
K022295 · MQL
Vitrolife Sweden AB
Obstetrics & Gynecology · 58d
Cleared Sep 12, 2002
PORTA OP SOLDER W-2
K022454 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 48d
Cleared Sep 12, 2002
AUROPAL SOLDER M-1
K022459 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 48d
Cleared Sep 12, 2002
SURESTEP BLOOD GLUCOSE MONITORING SYSTEM
K022724 · NBW
Lifescan, Inc.
Chemistry · 27d
Cleared Sep 12, 2002
GE ROAD WARRIOR PET CT IMAGING SYSTEM
K022872 · KPS
General Electric Co.
Radiology · 14d
Cleared Sep 12, 2002
INION CPS 2.5/2.8 SCREW
K022981 · HWC
Inion , Ltd.
Dental · 3d
Cleared Sep 11, 2002
VIDENT HEXTOP, SYNOCTA IN-CERAM BLANK/COPING MANUFACTURED BY VIDENT
K012473 · DZE
Vident
Dental · 405d
Cleared Sep 11, 2002
MADETT
K021044 · BTR
Wolfe Tory Medical, Inc.
Anesthesiology · 163d
Cleared Sep 11, 2002
BIOSOMNIA
K021485 · OMC
Oxford Biosignals Limited
Neurology · 126d
Cleared Sep 11, 2002
RADIONICS POLE NEEDLES
K021942 · GXI
Radionics, A Division of Tyco...
Neurology · 90d
Cleared Sep 11, 2002
CELL ROBOTICS ULTRA-LIGHT PEEL LASER SYSTEM
K021946 · GEX
Cell Robotics, Inc.
General & Plastic Surgery · 90d
Cleared Sep 11, 2002
JOSTRA VENT CATHETERS, MODELS LV & HKV
K022022 · DWF
Jostra AG
Cardiovascular · 83d
Cleared Sep 11, 2002
SOUNDVASER SYSTEM
K022051 · QPB
Sound Surgical Technologies, LLC
General & Plastic Surgery · 79d
Cleared Sep 11, 2002
CONVOY ADVANCED DELIVERY SHEATH
K022067 · DBY
Boston Scientific
Immunology · 78d
Cleared Sep 11, 2002
VERTIS PNT CONTROL UNIT, MODEL CU 100
K022241 · NHI
Vertis Neuroscience, Inc.
Neurology · 62d
Cleared Sep 11, 2002
ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD
K022331 · GKL
Bayer Diagnostics Corp.
Hematology · 55d
Cleared Sep 11, 2002
AUROPAL SOLDER W-2
K022451 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 47d
Cleared Sep 11, 2002
PORTA OP SOLDER M-1
K022452 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 47d
Cleared Sep 11, 2002
IQ PRODUCTS TRIPLE-COLOR FLOW CYTOMETRY REAGENTS, IQ PRODUCTS...
K022528 · GKZ
Iq Corp.
Hematology · 42d
Cleared Sep 11, 2002
MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE
K022677 · DQA
Alaris Medical Systems, Inc.
Anesthesiology · 30d
Cleared Sep 11, 2002
PORTABLE THERAPEUTIC OXYGEN CONCENTRATION SYSTEM (PTOCS)
K022684 · CAW
Essex Cryogenics of Missouri, Inc.
Anesthesiology · 30d
Cleared Sep 11, 2002
NESS SYSTEM
K022776 · IPF
Ness-Neuromuscular Electrical...
Physical Medicine · 21d