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."
1–24 of 130
Search insights Median review: 15d Cleared: 100% Top manufacturer: Clinical Data, Inc. Lead specialty: Radiology
Cleared May 31, 2005
STRYKER RF COAXIAL BIPOLAR ELECTRODES & CANNULAE
K043442 · GXI
Stryker Instruments
Neurology · 168d
Cleared Apr 20, 2005
SURPASSON P5 NEWTRON
K050895 · ELC
Satelec
Dental · 12d
Cleared Apr 13, 2005
TELEREHAD 2004
K050778 · DRG
Scottcare
Cardiovascular · 16d
Cleared Apr 11, 2005
PLIX
K050414 · BYJ
Respironics, Inc.
Anesthesiology · 52d
Cleared Apr 01, 2005
THIGH AND FOOT POSITIONER, SUPRONE PLUS, MODEL RT-6010
K050701 · IYE
Bionix Development Corp.
Radiology · 14d
Cleared Mar 04, 2005
AMPLIEF WRIST BLOOD PRESSURE MONITOR, MODEL M600
K050413 · DXN
Amplife Corporation
Cardiovascular · 14d
Cleared Feb 24, 2005
BIS SRS (SEMI-RESUABLE SENSOR)
K050313 · GWY
Aspect Medical Systems, Inc.
Neurology · 15d
Cleared Feb 18, 2005
AQUINOX
K050314 · BTT
Smiths Medical Asd, Inc.
Anesthesiology · 9d
Cleared Feb 16, 2005
TURBO TEMP TRIO
K050230 · FLL
Cardinal Health, Alaris Products
General Hospital · 15d
Cleared Feb 15, 2005
PLANET 50 MONITORING SYSTEM
K043370 · MWI
Larsen & Toubro Limited
Cardiovascular · 69d
Cleared Feb 10, 2005
EVIS EXERA BRONCHOVIDEOSCOPE, OLYMPUS XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2AC
K050220 · EOQ
Olympus Medical Systems Corporation
Ear, Nose, Throat · 10d
Cleared Feb 01, 2005
OMNIPRO SYSTEM
K050143 · OLV
Mays and Associates, Inc.
Neurology · 11d
Cleared Feb 01, 2005
MODEL SC-3008 SEQUENTIAL CIRCULATOR
K043423 · JOW
Bio Compression Systems, Inc.
Cardiovascular · 50d
Cleared Jan 28, 2005
EVIS EXERA COLONOVIDEOSCOPE MODEL XCF-Q160W1L/1
K043487 · FDF
Aizu Olympus Co., Ltd.
Gastroenterology & Urology · 42d
Cleared Jan 27, 2005
AMPLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL M100
K043550 · DXN
Amplife Corporation
Cardiovascular · 35d
Cleared Jan 24, 2005
INTEGRITY, MODEL V500
K043396 · GWJ
Vivosonic, Inc.
Neurology · 45d
Cleared Jan 04, 2005
HORIZON MEDICAL IMAGING
K043146 · LLZ
Mckesson Medical Imaging Company
Radiology · 50d
Cleared Dec 22, 2004
NEEDLE INCAPACITATOR (NEEDLE GUARD)
K042907 · FMI
Pdmp, Inc.
General Hospital · 62d
Cleared Dec 21, 2004
SA8000 SE DIAGNOSTIC ULTRASOUND SYSTEM
K043455 · IYN
Medison Co., Ltd.
Radiology · 6d
Cleared Dec 21, 2004
OLYMPUS ENDOARM
K043128 · GWG
Olympus Corporation
Neurology · 39d
Cleared Dec 09, 2004
OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER
K043275 · IYO
Olympus Medical Systems Corporation
Radiology · 13d
Cleared Dec 08, 2004
ESTEEM BLUE POLYISOPRENE SURGICAL GLOVES WITH COATING (CONTAINING CHITOSAN,...
K042574 · KGO
Cardinalhealth
General Hospital · 77d
Cleared Nov 24, 2004
ADSEAL ROOT CANAL SEALER
K042769 · KIF
Meta Biomed Co., Ltd.
Dental · 50d
Cleared Nov 22, 2004
PET-DOSE
K042746 · KPT
Comecer S.R.L.
Radiology · 49d