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"
49–72 of 335
Search insights Median review: 15d Cleared: 100% Top manufacturer: Ge Medical Systems, LLC Lead specialty: Radiology
Cleared Nov 03, 2010
OBS DISPOSABLE ELECTROSURGICAL PADS, MONOPOLAR, BIOPOLAR, MODELS GBS-DM, GBS-DB
K102372 · GEI
Jiangmen City Xinhui Baisheng Medical...
General & Plastic Surgery · 75d
Cleared Sep 24, 2010
ISOLED AC-POWERED LED HEADLIGHT SYSTEM
K102266 · FST
Isolux, LLC
General & Plastic Surgery · 45d
Cleared Sep 21, 2010
CRITICAL CARE ASSESSMENT
K101983 · JOM
Critical Patient Care, Inc.
Cardiovascular · 69d
Cleared Sep 13, 2010
MOLDEX-METRIC HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL...
K102173 · MSH
Moldex/Metric, Inc.
General Hospital · 42d
Cleared Aug 27, 2010
DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE
K101889 · ITH
Pivotal Health Solutions
Physical Medicine · 51d
Cleared Aug 20, 2010
DENTAL HANDPIECES, MODELS: KARAM STD/MINI
K101717 · EFB
Aerobine, Inc.
Dental · 63d
Cleared Aug 17, 2010
STELLARIS PC VISION ENHANCEMENT SYSTEM
K101325 · HQC
Bausch & Lomb, Inc.
Ophthalmic · 97d
Cleared Aug 13, 2010
GAUNYING INFRARED LAMP
K102149 · ILY
Foshan Gaunying Electronics Co., Ltd.
Physical Medicine · 14d
Cleared Aug 11, 2010
VITABLOCS
K102128 · EIH
Vita Zahnfabrik H.Rauter GmbH & Co.
Dental · 13d
Cleared Jul 22, 2010
SOLARIS REUSABLE AND DISPOSABLE BLOOD PRESSURE CUFFS
K101972 · DXQ
Solaris Medical Technology, Inc.
Cardiovascular · 9d
Cleared Jul 09, 2010
FIL 1520
K101629 · CAH
Glenn Medical Systems, Inc.
General Hospital · 29d
Cleared Jun 08, 2010
VITAL SIGNS MONITOR-VSM 6000 SERIES
K101445 · MWI
Welch Allyn, Inc.
Cardiovascular · 15d
Cleared May 12, 2010
BWF-5 MEDICAL LASER SERIES
K093087 · GEX
Litecure, LLC
General & Plastic Surgery · 223d
Cleared Apr 14, 2010
WELCH ALLYN NON INVASIVE BLOOD PRESSURE (NIBP) DEVICE
K093907 · DXN
Welch Allyn, Inc.
Cardiovascular · 113d
Cleared Mar 30, 2010
RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
K100712 · FCG
Boston Scientific Corporation
Gastroenterology & Urology · 18d
Cleared Feb 12, 2010
MODIFIED STRAIGHT FIRE LASER FIBER
K100078 · GEX
Boston Scientific Corp
General & Plastic Surgery · 31d
Cleared Dec 15, 2009
ENDO SMARTCAP
K093665 · FAJ
Byrne Medical, Inc.
Gastroenterology & Urology · 20d
Cleared Dec 11, 2009
ACCUMAX
K093691 · GEX
Boston Scientific Corp
General & Plastic Surgery · 11d
Cleared Nov 30, 2009
ERBELIFT HAND PUMP AND FLEXIBLE PROBE
K092090 · FBK
Byrne Medical, Inc.
Gastroenterology & Urology · 139d
Cleared Oct 30, 2009
INTEGRATED REGISTRATION
K093234 · LLZ
GE Medical Systems SCS
Radiology · 15d
Cleared Oct 21, 2009
NEUROCALM MODEL 1 AND 2
K090866 · GZJ
Neuromed Devices, Inc.
Neurology · 204d
Cleared Aug 17, 2009
AEM DISPOSABLE ELECTRODES,MODEL ESO300 SERIES
K091074 · GEI
Encision, Inc.
General & Plastic Surgery · 125d
Cleared Aug 11, 2009
PROTEUS 235 PROTON THERAPY SYSTEM
K091629 · LHN
Ion Beam Applications S.A.
Radiology · 69d
Cleared Jul 28, 2009
SHARP CHUTE
K091690 · MMK
Heathrow Scientific, LLC
General Hospital · 48d