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

335 results for "Intertek Testing Services"
73–96 of 335
Search insights Median review: 15d Cleared: 100% Top manufacturer: Aloka Co., Ltd. Lead specialty: Radiology
Cleared Jul 17, 2009
OPTIMA MR450W
K091536 · LNH
Ge Medical Systems, LLC
Radiology · 52d
Cleared Jul 07, 2009
MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER
K090670 · FLE
Midmark Corp.
General Hospital · 116d
Cleared May 18, 2009
VS-100 ILLUMINATION AND IMAGING SYSTEM
K090800 · FET
Schoelly Imaging, Inc.
Gastroenterology & Urology · 55d
Cleared May 08, 2009
MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEM
K091257 · FCG
Medi-Globe Corporation
Gastroenterology & Urology · 9d
Cleared Apr 08, 2009
ELECTRONIC HOUSE CALL
K090801 · DRG
Express MD Solutions, LLC
Cardiovascular · 15d
Cleared Mar 31, 2009
SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM
K090722 · BTY
Shape Medical Systems, Inc.
Anesthesiology · 12d
Cleared Mar 16, 2009
UROCARE
K090552 · LLZ
Neusoft Medical Systems Co., Ltd.
Radiology · 14d
Cleared Feb 19, 2009
ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332,...
K090296 · KPT
Biodex Medical Systems, Inc.
Radiology · 13d
Cleared Feb 05, 2009
TENS-EMS-14
K083030 · GZJ
Emsi
Neurology · 118d
Cleared Feb 04, 2009
SPYSCOPE ACCESS AND DELIVERY CATHETER
K090170 · ODF
Boston Scientific Corp
Gastroenterology & Urology · 12d
Cleared Jan 22, 2009
RAYAUTOPLAN 1.0
K083264 · MUJ
Raysearch Laboratories AB
Radiology · 78d
Cleared Dec 11, 2008
EXPANDED SPECTRUM PHOTO THERAPY DEVICE, MODEL ESPT-3X
K083560 · ILY
Lighthouse Technical Innovations, Inc.
Physical Medicine · 9d
Cleared Nov 07, 2008
ONCENTRA RT VIEWER 1.0
K082642 · MUJ
Nucletron Corporation
Radiology · 57d
Cleared Nov 04, 2008
DISCOVERY MR450
K083147 · LNH
Ge Medical Systems, LLC
Radiology · 11d
Cleared Oct 22, 2008
RAYDOSE
K082221 · MUJ
Raysearch Laboratories AB
Radiology · 77d
Cleared Oct 17, 2008
GE XTREME INJECTOR OPTION
K082960 · JAK
Ge Medical Systems, LLC
Radiology · 14d
Cleared Oct 16, 2008
CRYSTALSERT CRYSTALENS DELIVERY SYSTEM
K082944 · MSS
Bausch & Lomb, Inc.
Ophthalmic · 14d
Cleared Oct 16, 2008
STRAIGHT FIRE HOLMIUM LASER FIBER
K082928 · GEX
Boston Scientific Corp
General & Plastic Surgery · 15d
Cleared Oct 15, 2008
CURATIVE980 DIODE LASER
K082445 · GEX
Oroscience, Inc.
General & Plastic Surgery · 51d
Cleared Oct 10, 2008
PATIENT MONITORING CABLES FOR ECG, EKG, SPO2 AND BLOOD PRESSURE MONITORS
K082959 · DSA
Unimed Medical Supplies, Inc.
Cardiovascular · 7d
Cleared Oct 10, 2008
TEMPUSIC PATIENT MONITOR
K082718 · DXH
Remote Diagnostic Technologies , Ltd.
Cardiovascular · 23d
Cleared Oct 08, 2008
GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM
K082816 · JAK
Ge Medical Systems, LLC
Radiology · 13d
Cleared Oct 08, 2008
WELL LEAD SILICONE AND LATEX FOLEY CATHETERS
K082815 · EZL
Well Lead Medical Instruments
Gastroenterology & Urology · 13d
Cleared Oct 08, 2008
GE LIGHTSPEED 7.2 CT SCANNER SYSTEM
K082761 · JAK
Ge Medical Systems, LLC
Radiology · 16d