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"
193–216 of 335
Search insights Median review: 15d Cleared: 100% Top manufacturer: Aloka Co., Ltd. Lead specialty: Radiology
Cleared Oct 24, 2006
INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS
K062665 · MSH
Inovel, LLC
General Hospital · 47d
Cleared Oct 11, 2006
MOLDEX HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS
K062663 · MSH
Moldex/Metric, Inc.
General Hospital · 34d
Cleared Oct 06, 2006
FLEXITOUCH SYSTEM
K062818 · JOW
Tactile Systems Technology, Inc.
Cardiovascular · 16d
Cleared Sep 29, 2006
MAXIFLEX-SEMI FLEX SCOPE
K062725 · FGB
Technology Delivery Systems, Inc.
Gastroenterology & Urology · 16d
Cleared Sep 22, 2006
ACTICAL
K060919 · GWK
Respironics, Inc.
Neurology · 171d
Cleared Sep 08, 2006
MINI POWER CHAIR, MODEL MN 5000
K062483 · ITI
Line Ind.(Shanghai) Co., Ltd.
Physical Medicine · 14d
Cleared Aug 28, 2006
LC SPRINT STAR
K062158 · CAF
Pari Innovative Manufacturers, Inc.
Anesthesiology · 31d
Cleared Aug 22, 2006
NANOTHERM, VASCUTHERM AND PROTHERMO THERAPY WRAPS
K061866 · JOW
Thermotek, Inc.
Cardiovascular · 50d
Cleared Aug 21, 2006
Z-BLOCK, MODELS 20/19, 40/19, 55/19
K062389 · EIH
Foundation Milling Centre
Dental · 5d
Cleared Aug 18, 2006
COMFORT FLO HUMIDIFICATION SYSTEM AND NASAL CANNULA
K061736 · BTT
Teleflex Medical
Anesthesiology · 59d
Cleared Aug 08, 2006
POROUS MEDIA HUMIDIFLOW HUMIDIFIER FOR UNIVERSAL HUMIDIFICATION
K062091 · BTT
Porous Media Corp.
Anesthesiology · 15d
Cleared Aug 01, 2006
MODEL MULTI-FLO IC-1545-KT/-F INTERMITTENT CIRCULATOR
K061857 · JOW
Bio Compression Systems, Inc.
Cardiovascular · 32d
Cleared Jul 25, 2006
SURGI-CUF REUSABLE, RS SERIES
K061962 · DXQ
Ethox International
Cardiovascular · 13d
Cleared Jul 21, 2006
PELEX-04 WIRELESS ELECTROCARDIOGRAPH WITH SOFTWARE ACCESSORIES
K061977 · DXH
Pinmed, Inc.
Cardiovascular · 8d
Cleared Jul 12, 2006
INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS & SURGICAL MASKS
K061859 · MSH
Inovel, LLC
General Hospital · 12d
Cleared Jul 12, 2006
LIGHTSPEED 7.1 CT SCANNER SYSTEM
K061817 · JAK
Ge Medical Systems, LLC
Radiology · 14d
Cleared Jul 12, 2006
GALAXY
K061816 · MWI
Larsen & Toubro Limited
Cardiovascular · 14d
Cleared Jul 12, 2006
ACP OMNIPAD LIGHT THERAPY SYSTEM & ACP OMNIPAD 500 CONTROL UNIT
K060191 · ILY
Accelerated Care Plus Corp.
Physical Medicine · 168d
Cleared Jul 11, 2006
FOCUS VNG/ENG TYPE 1068
K061791 · GWN
Gn Otometrics A/S
Neurology · 15d
Cleared Jun 27, 2006
MEDI-GLOBE ROTA-CUT SPHINCTEROTOME
K061684 · KNS
Medi-Globe Corporation
Gastroenterology & Urology · 12d
Cleared Jun 26, 2006
AUTOBONE2
K061625 · JAK
Ge Healthcare
Radiology · 14d
Cleared Jun 26, 2006
OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH FLUIDIC SEAL WITH/WITHOUT HEPARIN
K061159 · DQE
Hospira, Inc.
Cardiovascular · 61d
Cleared Jun 23, 2006
FULLCARD ANALYSIS
K061587 · KPS
Ge Healthcare
Radiology · 15d
Cleared Jun 21, 2006
SMDIE DEVICE INTERFACING SYSTEM
K061590 · MWI
Siemens Medical Solutions Health...
Cardiovascular · 13d