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"
313–335 of 335
Search insights Median review: 15d Cleared: 100% Top manufacturer: Aloka Co., Ltd. Lead specialty: Radiology
Cleared May 05, 2003
CDR PANX, MODEL 4792
K031291 · MUH
Schick Technologies, Inc.
Radiology · 12d
Cleared Mar 24, 2003
XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT
K030194 · KNS
The Olympus Optical Co.
Gastroenterology & Urology · 62d
Cleared Feb 26, 2003
SENORX ES-300
K030473 · GEI
Senorx, Inc.
General & Plastic Surgery · 14d
Cleared Dec 20, 2002
XTJF-160AF DUODENOVIDEOSCOPE
K024033 · FDT
Olympus Optical Co., Ltd.
Gastroenterology & Urology · 14d
Cleared Dec 18, 2002
ALOKA SSD-3500 ULTRASOUND SYSTEM
K023996 · IYN
Aloka Co., Ltd.
Radiology · 15d
Cleared Oct 21, 2002
NXSTAGE PREMIXED DIALYSATE
K022913 · KPO
Nxstage Medical, Inc.
Gastroenterology & Urology · 48d
Cleared May 10, 2002
GERM TERMINATOR GT 100 TOOTHBRUSH SANITIZER
K021258 · MCF
Germ Terminator Corporation
Dental · 21d
Cleared May 01, 2002
OLYMPUS BF TYPE UM40
K021204 · PSV
Olympus Optical Co., Ltd.
Radiology · 15d
Cleared Dec 07, 2001
DAYLITE XENON LIGHT SOURCES
K013880 · GCT
Designs For Vision, Inc.
Gastroenterology & Urology · 14d
Cleared Oct 11, 2001
CANDELA CLEARBEAM PULSED DYE LASER
K013043 · GEX
Candela Corp.
General & Plastic Surgery · 31d
Cleared Sep 04, 2001
ES-2000 SHAPE SELECT ELECTROSURGICAL SCALPEL
K012799 · GEI
Senorx, Inc.
General & Plastic Surgery · 14d
Cleared Aug 16, 2001
ABN ANEROID SPHYGMOMANOMETER
K012444 · DXQ
Pt. Sugih Instrumendo Abadi
Cardiovascular · 15d
Cleared Aug 13, 2001
GULLIVER AND CLASSE A
K012213 · EIA
American Dental Technologies, Inc.
Dental · 28d
Cleared Jun 01, 2001
SENTINEL ENTERAL FEEDING PUMP, LH2001 ENTERAL FEEDING PUMP
K011587 · LZH
Entracon Corp.
General Hospital · 9d
Cleared May 23, 2001
ALOKA SSD-5500 WITH KI AND A-SMA
K011457 · IYN
Aloka Co., Ltd.
Radiology · 12d
Cleared May 15, 2001
SSD 5500 WITH OLYMPUS GF TYPE UC140P-AL5
K011315 · IYN
Aloka Co., Ltd.
Radiology · 15d
Cleared May 15, 2001
OLYMPUS GF UC140P-AL5 ULTRASONIC ENDOSCOPE WITH ALOKA SSD-5500 ULTRASOUND SYSTEM
K011314 · ITX
Aloka Co., Ltd.
Radiology · 15d
Cleared Dec 27, 2000
ALOKA SSD-4000
K003739 · IYN
Aloka Co., Ltd.
Radiology · 23d
Cleared Oct 18, 2000
MIDMARK PROCENTER INSTRUMENT DELIVERY SYSTEM
K003090 · EIA
Midmark Corp.
Dental · 15d
Cleared Sep 20, 2000
ALOKA UST-5280-5
K002784 · ITX
Aloka Co., Ltd.
Radiology · 14d
Cleared May 16, 2000
OPTIVU HDVD SYSTEM
K001169 · GCJ
Optimize, Inc.
General & Plastic Surgery · 35d
Cleared Aug 24, 1999
ALOKA SSD-5500 DIAGNOSTIC ULTRASOUND SYSTEM
K992663 · IYN
Aloka Co., Ltd.
Radiology · 15d
Cleared Jun 11, 1999
BMT ANSCORE HEALTH MANAGEMENT SYSTEM, MODEL 1.1
K991831 · DPS
Boston Medical Technologies, Inc.
Cardiovascular · 14d