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"
289–312 of 335
Search insights Median review: 15d Cleared: 100% Top manufacturer: Aloka Co., Ltd. Lead specialty: Radiology
Cleared Sep 17, 2004
SCEPTREP3 PET/CT
K042428 · KPS
Hitachi Medical Systems America, Inc.
Radiology · 9d
Cleared Sep 10, 2004
VARILITE LASER SYSTEM
K041930 · GEX
Iridex Corporation
General & Plastic Surgery · 53d
Cleared Aug 26, 2004
11000 RAPTURE PHASED ARRAY PERIPHERAL VASCULAR COIL
K042207 · MOS
Usa Instruments, Inc.
Radiology · 10d
Cleared Aug 26, 2004
SPECTRUM AND SPECTRUM WITH MASTER DRUG LIBRARY
K042121 · FRN
Sigma Intl.
General Hospital · 20d
Cleared Aug 18, 2004
OLYMPUS BF TYPE UC160-OL8
K042140 · ODG
Olympus Corporation
Radiology · 9d
Cleared Jul 30, 2004
ALOKA SSD-ALPHA 5 ULTRASOUND SYSTEM
K041916 · IYN
Aloka Co. Ltd USA
Radiology · 14d
Cleared Jul 23, 2004
NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT)
K040913 · MXK
Bausch & Lomb
Ophthalmic · 106d
Cleared Jun 22, 2004
COMPACS, VERSION 1.0
K041581 · LLZ
Intelligent Images Srl
Radiology · 8d
Cleared May 18, 2004
S-SCORT...JR QUICKDRAW, MODEL 2400
K041154 · BTA
Sscor
General & Plastic Surgery · 15d
Cleared May 14, 2004
TORSO ARRAY COIL, MODEL 558GE-64
K041185 · MOS
Igc-Medical Advances, Inc.
Radiology · 8d
Cleared Apr 21, 2004
HITACHI PRESTO
K040902 · JAK
Hitachi Medical Systems America, Inc.
Radiology · 14d
Cleared Mar 26, 2004
ALOKA MODEL SSD-4000 DIAGNOSTIC ULTRASOUND SYSTEM W/OPTIONAL SONOREAL 3D...
K040719 · IYO
Aloka Co., Ltd.
Radiology · 7d
Cleared Mar 23, 2004
INTRA ORAL CAMERA SYSTEM & ACCESSORIES, MODEL WIN-100D
K040691 · EIA
Win-Us Technology Co., Ltd.
Dental · 6d
Cleared Mar 22, 2004
MODEL 475 - 8 CHANNEL T/R PHASED ARRAY LOWER EXTREMITY COIL
K040640 · MOS
Igc-Medical Advances, Inc.
Radiology · 12d
Cleared Mar 17, 2004
DERMAWAVE 5000 COMBI MAX SYSTEM
K040121 · IMG
Dermawave, LLC
Physical Medicine · 57d
Cleared Oct 29, 2003
ALOKA SSD-5000 V5.0 ULTRASOUND SYSTEM
K033311 · IYN
Aloka Co., Ltd.
Radiology · 15d
Cleared Oct 20, 2003
HITACHI CB MERCURAY DENTAL CONE-BEAM X-RAY SYSTEM
K033248 · MUH
Hitachi Medical Systems America, Inc.
Radiology · 13d
Cleared Oct 16, 2003
DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION
K033244 · OWB
Ge Medical Systems, Inc.
Radiology · 9d
Cleared Sep 30, 2003
ALOKA MODEL SSD-5500 V6.0 ULTRASOUND SYSTEM
K032875 · IYO
Aloka Co. Ltd USA
Radiology · 15d
Cleared Aug 25, 2003
INTRA ORAL CAMERA SYSTEM AND ACCESSORIES, MODEL CLARIS I310
K032341 · EIA
Sota Precision Optics, Inc.
Dental · 27d
Cleared Aug 19, 2003
SIROTORQUE L
K031584 · EBW
Sirona Dental Systems GmbH
Dental · 90d
Cleared Jul 16, 2003
OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE
K032092 · FCL
Olympus Optical Co., Ltd.
Gastroenterology & Urology · 9d
Cleared Jul 07, 2003
NXSTAGE SYSTEM ONE
K030470 · FII
Nxstage Medical, Inc.
Gastroenterology & Urology · 145d
Cleared Jun 30, 2003
INTERFERENTIAL STIMULATOR, MODEL NETWAVE
K031884 · IPF
Ryan Telemedicine
Physical Medicine · 12d