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"
265–288 of 335
Search insights Median review: 15d Cleared: 100% Top manufacturer: Aloka Co., Ltd. Lead specialty: Radiology
Cleared Jul 01, 2005
GF-UE160-AL5 ULTRASOUND ENDOSCOPE
K051541 · FDF
Olympus America, Inc.
Radiology · 21d
Cleared Jun 29, 2005
SUPER VIEW DISPOSABLE BIOM LENS SET
K051630 · HJK
Insight Instruments, Inc.
Ophthalmic · 12d
Cleared Jun 29, 2005
STAR 50 MONITORING SYSTEM
K051608 · MWI
Larsen & Toubro Limited
Cardiovascular · 12d
Cleared Jun 28, 2005
SMALL INTESTINAL VIDEOSCOPE SYSTEM
K051551 · KNT
Olympus Medical Systems Corporation
Gastroenterology & Urology · 15d
Cleared Jun 16, 2005
SPYSCOPE ACCESS AND DELIVERY CATHETER
K051504 · FED
Boston Scientific Corp
Gastroenterology & Urology · 9d
Cleared May 25, 2005
BLUELEX
K051203 · EBZ
Monitex Industrial Co., Ltd.
Dental · 14d
Cleared May 19, 2005
INOVEL HEALTH CARE MODEL N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS
K051182 · MSH
Inovel, LLC
General Hospital · 10d
Cleared May 12, 2005
ESSENPACS
K051081 · LLZ
Cymed Engineering, Inc.
Radiology · 15d
Cleared May 10, 2005
PAINACEA MODEL XR8 INFRARED HEAT LAMP
K051046 · ILY
Atlantis Luminescent Products, LLC
Physical Medicine · 15d
Cleared May 03, 2005
E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101
K051077 · EGS
Aseptico, Inc.
Dental · 6d
Cleared May 02, 2005
REMREST HEATED HUMIDIFIER
K050990 · BTT
Medical Industries America, Inc.
Anesthesiology · 13d
Cleared Apr 13, 2005
REHABILICARE IF 3 WAVE INTERFERENTIAL STIMULATOR SYSTEM, MODEL 7110S
K050046 · IPF
Compex Technologies, Inc.
Physical Medicine · 93d
Cleared Mar 11, 2005
INNOVA 2100
K050489 · OWB
Ge Medical Systems, LLC
Radiology · 14d
Cleared Mar 04, 2005
SPYGLASS DIRECT VISULATION PROBE
K050403 · ODF
Boston Scientific Corp
Gastroenterology & Urology · 15d
Cleared Feb 22, 2005
PSD-60/ENDOPLASMA
K042274 · GEI
Olympus Shirakawa Co., Ltd.
General & Plastic Surgery · 183d
Cleared Feb 07, 2005
PALM PRO PREMIUM, MODEL 6PF1 & PALM PRO, MODEL 6PF2, LATEX EXAM GLOVE
K050152 · LYY
Dipped Products (Thailand), Ltd.
General Hospital · 14d
Cleared Jan 27, 2005
LAPAROCISION SCOPE CONTROLLER SYSTEM
K050027 · GCJ
Gmp/Companies, Inc.
General & Plastic Surgery · 21d
Cleared Dec 21, 2004
THE RELIANCE PI PROCESS INDICATOR, MODEL D5116
K043482 · JOJ
STERIS Corporation
General Hospital · 4d
Cleared Dec 17, 2004
CLAREON AND SOLARUS PULSED LIGHT DEVICES AND ACCESSORIES
K043319 · GEX
Novalis Medical, LLC
General & Plastic Surgery · 15d
Cleared Nov 30, 2004
ALOKA SSD-ALPHA 10 ULTRASOUND SYSTEM
K043196 · IYN
Aloka Co., Ltd.
Radiology · 12d
Cleared Nov 24, 2004
NX STAGE WATER PURIFICATION SYSTEM
K042089 · FIP
Nxstage Medical, Inc.
Gastroenterology & Urology · 113d
Cleared Nov 18, 2004
ADVANCED LUNG ANALYSIS II
K042694 · OEB
GE Medical Systems
Radiology · 49d
Cleared Oct 22, 2004
DIGITAL DETECTOR, MODEL GR17
K042821 · MQB
Anrad Corp.
Radiology · 10d
Cleared Oct 06, 2004
BALANCEBACK VNG SYSTEM
K042529 · GWN
Fall Prevention Technologies, LLC
Neurology · 19d