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."
49–72 of 130
Search insights Median review: 15d Cleared: 100% Top manufacturer: Clinical Data, Inc. Lead specialty: Radiology
Cleared Jul 13, 2004
RAPIDIACOLON
K041761 · LLZ
Infinitt Co., Ltd.
Radiology · 13d
Cleared Jul 06, 2004
BIS PEDIATRIC SENSOR
K041670 · GXY
Aspect Medical Systems, Inc.
Neurology · 15d
Cleared Jun 30, 2004
HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
K041550 · FRN
Abbott Laboratories
General Hospital · 21d
Cleared Jun 25, 2004
SPSMEDICAL AIRVIEW BOWIE DICK TEST PACK
K041017 · JOJ
Spsmedical Supply Corp.
General Hospital · 66d
Cleared Jun 21, 2004
STARPACS ORTHOPEDICS SYSTEM
K041500 · LLZ
Infinitt Co., Ltd.
Radiology · 14d
Cleared Jun 16, 2004
DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL C5I
K040443 · LLZ
Dome Imaging Systems, Inc.
Radiology · 117d
Cleared Jun 10, 2004
AIRLIFE MISTY FINITY LARGE VOLUME CONTINUOUS NEBULIZER
K041418 · CAF
Cardinalhealth
Anesthesiology · 14d
Cleared Jun 08, 2004
IPACS ORTHO
K041366 · LLZ
Realtimeimage, Inc.
Radiology · 15d
Cleared Jun 08, 2004
NON STERILE SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES
K041041 · LYZ
Shanghai Foremost Plastic Industrial...
General Hospital · 47d
Cleared May 28, 2004
TRANSNEB COMPRESSOR W/NEBULIZER, MODEL 5000
K032170 · CAF
Medical Industries America, Inc.
Anesthesiology · 317d
Cleared May 21, 2004
VITALAB IRON REAGENT
K033983 · JIY
Clinical Data, Inc.
Chemistry · 150d
Cleared May 17, 2004
SIEMENS ENHANCED IMAGING SYSTEM
K041166 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 13d
Cleared May 03, 2004
FIBREX CATHETER PATENCY DEVICE
K040427 · FOZ
Medical Device Technologies, Inc.
General Hospital · 74d
Cleared Apr 19, 2004
BRONCHOVIDEOSCOPE OLYMPUS XBF-D160HM
K040940 · EOQ
Olympus Corporation
Ear, Nose, Throat · 7d
Cleared Apr 09, 2004
PELVIS BELLYBOARD PLUS PATIENT POSITIONING SYSTEM
K040773 · IYE
Bionix Development Corp.
Radiology · 14d
Cleared Apr 07, 2004
PROTAB ECG TABB ELECTRODE
K040784 · DRX
Bio Protech, Inc.
Cardiovascular · 9d
Cleared Mar 18, 2004
VITALAB DIRECT BILIRUBIN REAGENT
K040631 · CIG
Clinical Data, Inc.
Chemistry · 8d
Cleared Mar 18, 2004
ALICE 5
K040595 · OLZ
Respironics, Inc.
Neurology · 10d
Cleared Mar 15, 2004
ETHOX SURGI-CUF ADULT DISPOSABLE BLOOD PRESSURE CUFFS
K040286 · DXQ
Ethox Corp.
Cardiovascular · 38d
Cleared Mar 11, 2004
VITALAB AMYLASE REAGENT
K040534 · JFJ
Clinical Data, Inc.
Chemistry · 9d
Cleared Mar 10, 2004
VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR
K034000 · CDT
Clinical Data, Inc.
Chemistry · 77d
Cleared Mar 08, 2004
VITALAB MAGNESIUM REAGENT
K040508 · JGJ
Clinical Data, Inc.
Chemistry · 10d
Cleared Mar 08, 2004
VITALAB URIC ACID REAGENT
K040467 · KNK
Clinical Data, Inc.
Chemistry · 13d
Cleared Feb 25, 2004
BISX
K040183 · OLW
Aspect Medical Systems, Inc.
Neurology · 29d