FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

130 results for "Entela, Inc."
73–96 of 130
Search insights Median review: 15d Cleared: 100% Top manufacturer: Clinical Data, Inc. Lead specialty: Radiology
Cleared Feb 13, 2004
LEVIA PHOTOTHERAPY SYSTEM
K040062 · FTC
Lerner Medical Devices, Inc.
General & Plastic Surgery · 31d
Cleared Jan 27, 2004
HEEL SNUGGLER, MODEL 99047
K040044 · MPO
Respironics, Inc.
Physical Medicine · 15d
Cleared Dec 23, 2003
IRRIGATION CHANNEL TUBING, MODEL 100135
K033695 · OCX
Byrne Medical, Inc.
Gastroenterology & Urology · 28d
Cleared Dec 19, 2003
PLASMACURE BXE
K033795 · EBZ
Eele Laboratories, LLC
Dental · 14d
Cleared Dec 18, 2003
UB 140
K033827 · ITI
Rivertrail Mobility
Physical Medicine · 8d
Cleared Nov 28, 2003
CWAS 1000
K033452 · IKN
Fasstech
Neurology · 29d
Cleared Nov 10, 2003
PLANET MONITORING SYSTEM
K032871 · MWI
Larsen & Toubro Limited
Cardiovascular · 56d
Cleared Nov 10, 2003
STAR (LUNAR SERIES) MONITORING SYSTEM
K032867 · MWI
Larsen & Toubro Limited
Cardiovascular · 56d
Cleared Nov 07, 2003
DGH 55 HANDHELD PACHYMETER (PACHMATE)
K033385 · IYO
Dgh Technology, Inc.
Radiology · 15d
Cleared Oct 31, 2003
K-TECH 2 POWER TILT SEATING SYSTEM, MODEL K2PT
K033263 · ITI
Track Corporation
Physical Medicine · 22d
Cleared Oct 16, 2003
EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND...
K033225 · EOQ
Olympus Optical Co., Ltd.
Ear, Nose, Throat · 10d
Cleared Oct 10, 2003
POWDER FREE VINYL EXAMINATION GLOVE
K032071 · LYZ
Shanghai Foremost Plastic Industrial...
General Hospital · 99d
Cleared Oct 08, 2003
WIDE 2MP TFT LCD MONITOR SYSTEM IF 1902A
K032960 · LLZ
Wide Corporation
Radiology · 15d
Cleared Oct 08, 2003
METAPASTE CALCIUM HYDROXIDE WITH BARIUM SULFATE TEMPORARY ROOT CANAL FILLING
K032605 · KIF
Meta Biomed Co., Ltd.
Dental · 44d
Cleared Oct 07, 2003
METAPEX CALCIUM HYDROXIDE WITH LODOFORM TEMPORARY ROOT CANAL FILLING
K032603 · KIF
Meta Biomed Co., Ltd.
Dental · 43d
Cleared Sep 26, 2003
IRRIGATION SETS
K032832 · HRX
Vital Concepts, Inc.
Orthopedic · 15d
Cleared Sep 12, 2003
QUANTUM WARP 10 LIGHT DELIVERY SYSTEM
K032229 · ILY
Quantum Devices, Inc.
Physical Medicine · 53d
Cleared Sep 11, 2003
DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM MODEL, C3 COLOR AND C3 GRAY
K032638 · LLZ
Planar Systems, Inc.
Radiology · 15d
Cleared Aug 25, 2003
STARBOND DENTAL BONDING ALLOYS
K032106 · EJT
Star Refining Precious Metals South...
Dental · 48d
Cleared Aug 01, 2003
DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODELS C2 AND C5I
K032202 · LLZ
Planar Systems, Inc.
Radiology · 14d
Cleared Jul 28, 2003
AIRBRUSH LIPOSCULPTOR SYSTEM
K031881 · QPB
Biosculpture Technology, Inc.
General & Plastic Surgery · 40d
Cleared Jul 24, 2003
WIDE 3MP GRAYSCALE TFT LCD MONITOR IF2103A
K032174 · LLZ
Wide Corporation
Radiology · 8d
Cleared Jul 08, 2003
5MP TFT LCD MONITOR SYSTEM IF2105A BY WIDE CORPORATION
K031929 · LLZ
Wide Corporation
Radiology · 15d
Cleared Jul 03, 2003
PHILIPS PAGE WRITER TRIM SERIES CARDIOGRAPH INCLUDING I, II, III, MODELS...
K031422 · DPS
Philips Medical Systems
Cardiovascular · 58d