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"
1–24 of 335
Search insights Median review: 15d Cleared: 100% Top manufacturer: Ge Medical Systems, LLC Lead specialty: Radiology
Cleared May 19, 2021
TENS & EMS Device
K202866 · NUH
Shenzhen Jian Feng Electronic...
Physical Medicine · 233d
Cleared Sep 27, 2012
TYPE 1077 ACCUSCREEN
K122067 · GWJ
Gn Otometrics
Neurology · 73d
Cleared Aug 31, 2012
PINTLER PATIENT WARMING SYSTEM
K113705 · DWJ
Pintler Medical
Cardiovascular · 259d
Cleared Jul 31, 2012
HQS INTRODUCER
K113849 · DYB
Alseal
Cardiovascular · 215d
Cleared Jun 13, 2012
SONIXGPS NEEDLE SENSOR
K111818 · IYO
Ultrasonix Medical Corporation
Radiology · 351d
Cleared May 23, 2012
AERODR X70
K121109 · KPR
Konica Minolta Medical & Graphic, Inc.
Radiology · 41d
Cleared May 02, 2012
CAIRE COMPANION 5 OXYGEN CONCENTRATOR
K121167 · CAW
Caire, Inc.
Anesthesiology · 15d
Cleared Apr 17, 2012
COPRESSION SYSTEMS (MODELS CMP-001 AND CMP-002)
K121001 · JOW
Novitas Medical, LLC
Cardiovascular · 15d
Cleared Apr 09, 2012
SONIXGPS VASCULAR ACCESS NEEDLE KIT
K120349 · DRE
Ultrasonix Medical Corpation
Cardiovascular · 63d
Cleared Mar 29, 2012
MCOMPASS ANORECTAL MANOMETRY SYSTEM
K120088 · KLA
Medspira, LLC
Gastroenterology & Urology · 78d
Cleared Mar 19, 2012
FILTEK BULK FILL FLOWABLE RESTORATIVE
K120453 · EBF
3M Espe Dental Products
Dental · 34d
Cleared Mar 15, 2012
CHOCOLATE PTA BALLON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014)
K120677 · LIT
Trireme Medical, Inc.
Cardiovascular · 9d
Cleared Mar 15, 2012
ENDOSCOPIC APPLICATOR
K120608 · GCJ
Micromedics, Inc.
General & Plastic Surgery · 15d
Cleared Feb 17, 2012
CLOSER TO NATURE ELECTRIC BREAST PUMP
K113664 · HGX
Mayborn Group Limited
Obstetrics & Gynecology · 66d
Cleared Feb 16, 2012
I-PORT ADVANCE INJECTION PORT
K120337 · FOZ
Unomedical A/S
General Hospital · 13d
Cleared Feb 07, 2012
SAFE SECURE STERILIZATION POUNCH WITH STEAM AND ETHYLENE OXIDE PROCESS...
K112591 · FRG
Safe Secure Packaging Co., Ltd.
General Hospital · 153d
Cleared Jan 19, 2012
CABLE/ LEAD-WIRE (ECG, EKG, SPO2 AND INVASIVE BLOOD PRESSURE)
K120010 · DSA
Shenzhen Med-Link Electronics Tech...
Cardiovascular · 16d
Cleared Jan 17, 2012
HYPERION
K113497 · MUH
Cefla S.C. Cefla Dental Group
Radiology · 53d
Cleared Jan 05, 2012
ORTHOSCAN MOBILE DI MINI C-ARM
K113708 · OXO
Orthoscan, Inc.
Radiology · 20d
Cleared Dec 20, 2011
POWER-LOAD COT FASTENER SYSTEM
K113598 · FPO
Stryker Medical
General Hospital · 15d
Cleared Dec 15, 2011
TEMPUSIC PATIENT MONITOR
K113105 · MWI
Remote Diagnostic Technologies , Ltd.
Cardiovascular · 56d
Cleared Dec 14, 2011
CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014 AND 0.018)
K111738 · DQY
Trireme Medical, Inc.
Cardiovascular · 176d
Cleared Dec 02, 2011
IMMULISA SCI-70 ANTIBODY ELISA
K113143 · LLL
Immco Diagnostics, Inc.
Immunology · 38d
Cleared Sep 22, 2011
RADIFORCE LARGE MONITOR SYSTEM
K112645 · DXJ
Eizo GmbH
Cardiovascular · 10d