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"
241–264 of 335
Search insights Median review: 15d Cleared: 100% Top manufacturer: Ge Medical Systems, LLC Lead specialty: Radiology
Cleared Jan 20, 2006
STELLAR 404T
K060058 · MWI
Larsen & Toubro Limited
Cardiovascular · 11d
Cleared Jan 13, 2006
ALOKA SD-3500 ULTRASOUND SYSTEM
K060059 · IYN
Aloka Co., Ltd.
Radiology · 4d
Cleared Jan 09, 2006
PRECISION OPTICS CORPORATION VIDEO OPHTHALMOSCOPE, MODEL 2500-VOS
K053425 · HLJ
Precision Optics Corp.
Ophthalmic · 32d
Cleared Jan 06, 2006
ALIGNRT
K052682 · IYE
Vision RT Limited
Radiology · 100d
Cleared Dec 20, 2005
MYNEB NEBULIZER, MODEL RDD100
K053203 · CAF
Respironics New Jersey, Inc.
Anesthesiology · 34d
Cleared Dec 01, 2005
SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL
K053248 · BYI
Electromed, Inc.
Anesthesiology · 10d
Cleared Nov 28, 2005
ESTEEM STRETCHY VINYL GLOVE WITH COATING
K052568 · LYZ
Cardinalhealth
General Hospital · 70d
Cleared Nov 17, 2005
CR-PRO
K052938 · MQB
Eradlink, Inc.
Radiology · 28d
Cleared Nov 10, 2005
JOSTRA HLM TUBING SET
K053025 · DWE
Maquet Cardiopulmonary, AG
Cardiovascular · 14d
Cleared Nov 08, 2005
ILUMA ORTHOCAT/DENTALCAT
K053046 · JAK
Imtec Corp.
Radiology · 11d
Cleared Nov 08, 2005
ADVANTAGE WORKSTATION 4.3.
K052995 · LLZ
Ge Healthcare
Radiology · 14d
Cleared Nov 01, 2005
BIS EEG MONITOR, MODEL BISX4
K052981 · OLW
Aspect Medical Systems, Inc.
Neurology · 8d
Cleared Oct 31, 2005
1125 XSB XENON FIBER-OPTIC LIGHT SOURCE
K052979 · HBI
Isolux, LLC
General & Plastic Surgery · 7d
Cleared Oct 31, 2005
ACCUVIX XQ DIAGNOSTIC ULTRASOUND SYSTEM
K052911 · IYN
Medison Co., Ltd.
Radiology · 14d
Cleared Oct 27, 2005
VIRTUAL MEDICAL SYSTEMS MODEL VT3000
K052904 · JXE
Scientific Imaging, Inc.
Neurology · 13d
Cleared Oct 12, 2005
SELECTFLOW - INTRAVASCULAR ADMINISTRATION SET
K052658 · FPA
Renascence Medical, Inc.
General Hospital · 15d
Cleared Oct 11, 2005
SPECTRAQUATTRO PULSED LIGHT SYSTEM
K052336 · GEX
Amjet Distribution, LLC
General & Plastic Surgery · 46d
Cleared Sep 27, 2005
ACTIHEART
K052489 · GWK
Respironics, Inc.
Neurology · 15d
Cleared Sep 21, 2005
SYNERAD IMPACT 60, SYNERAD IMPACT 72 AND ANALOGIC AMS1600
K052447 · JAK
Analogic Corp.
Radiology · 14d
Cleared Sep 16, 2005
INNOVA 2100-IQ, INNOVA 3100, INNOVA 3100-IQ, INNOVA 4100, AND INNOVA 4100-IQ
K052412 · OWB
Ge Healthcare
Radiology · 14d
Cleared Sep 14, 2005
ADVANTAGE SIM MD
K052345 · KPQ
Ge Healthcare
Radiology · 19d
Cleared Sep 09, 2005
BIS EEG MONITOR, MODEL A-3000
K052362 · OLW
Aspect Medical Systems, Inc.
Neurology · 11d
Cleared Aug 24, 2005
SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR
K052194 · ODF
Boston Scientific Corp
Gastroenterology & Urology · 13d
Cleared Jul 14, 2005
CERETOM, MODEL NL3000
K051765 · JAK
Neurologica Corporation
Radiology · 14d