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"
121–144 of 335
Search insights Median review: 15d Cleared: 100% Top manufacturer: Aloka Co., Ltd. Lead specialty: Radiology
Cleared May 13, 2008
MODIFICATION TO AESKULISA DS DNA G
K081251 · LSW
Aesku Diagnostics
Immunology · 11d
Cleared May 09, 2008
GE LIGHTSPEED CT750 HD (LIGHTSPEED 8.0)
K081105 · JAK
Ge Healthcare
Radiology · 21d
Cleared May 02, 2008
BIOMERS TRANSLUCENT ORTHODONTIC WIRE
K081143 · DYW
Biomers Product, LLC
Dental · 10d
Cleared May 02, 2008
AESKULISA ANA HEP-2, REF 30-7115US
K081104 · LKJ
Aesku Diagnostics
Immunology · 14d
Cleared Apr 29, 2008
TRANSPOSAL ULTRA SYSTEMS
K081047 · JCX
Dornoch Medical Systems, Inc.
General & Plastic Surgery · 15d
Cleared Apr 25, 2008
SIGNA 3.0T MR750 SYSTEM
K081028 · LNH
Ge Medical Systems, LLC
Radiology · 14d
Cleared Apr 16, 2008
ONCENTRA GYN
K080929 · MUJ
Nucletron Corporation
Radiology · 15d
Cleared Apr 09, 2008
IROOT SP
K080917 · KIF
Innovative Bioceramix, Inc.
Dental · 8d
Cleared Mar 18, 2008
DRIVE SOLSTICE OXYGEN CONCENTRATOR
K080391 · CAW
Medical Depot
Anesthesiology · 34d
Cleared Feb 26, 2008
CARDIQ FUNCTION XPRESS
K073153 · JAK
GE Medical Systems SCS
Radiology · 110d
Cleared Feb 22, 2008
XVIEWNET
K080290 · LLZ
American Radiologist Network, Inc.
Radiology · 18d
Cleared Feb 21, 2008
EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR
K070259 · CCJ
Bedfont Scientific, Ltd.
Anesthesiology · 391d
Cleared Feb 07, 2008
CHALLENGER/CLASSIC PUSH BUTTON HANDPIECE
K080240 · EFB
Promident, LLC
Dental · 7d
Cleared Feb 07, 2008
RK EPIDURAL NEEDLE
K072005 · BSP
Epimed International
Anesthesiology · 199d
Cleared Jan 28, 2008
DANE TECHNOLOGIES WHEELCHAIR MOVER, MODEL WM 2000
K073701 · ITI
Dane Technologies
Physical Medicine · 28d
Cleared Jan 10, 2008
INTUITION, MODEL 0170
K073632 · KPR
Arcoma AB
Radiology · 15d
Cleared Dec 27, 2007
SELF SEAL STERILIZATION POUCH
K071886 · FRG
Shanghai Jianzhong Medical Packaging...
General Hospital · 171d
Cleared Dec 19, 2007
SCANORA 3D
K073350 · MUH
Soredex Palodex Group OY
Radiology · 20d
Cleared Dec 13, 2007
MODIFICATION TO: EFLOW ELECTRONIC INHALER/NEBULIZER
K072670 · CAF
Pari Innovative Manufacturers, Inc.
Anesthesiology · 83d
Cleared Dec 11, 2007
EQUAL DOSE 1.0
K073273 · IYE
Nucletron Corporation
Radiology · 20d
Cleared Dec 11, 2007
PVMED DDR 2520 DIGITAL IMAGING SYSTEM
K072766 · IXK
Portavision Medical
Radiology · 74d
Cleared Dec 07, 2007
ONEPORT SURGICAL TROCAR SYSTEM
K073009 · GCJ
Conmed Corporation
General & Plastic Surgery · 43d
Cleared Dec 04, 2007
MILESMAN PREMIUM
K073300 · GEX
Milesman S.L.
General & Plastic Surgery · 11d
Cleared Nov 30, 2007
NEOCOIL 3.0T 32-CHANNEL TORSO ARRAY COIL FOR GE
K073236 · MOS
Neocoil
Radiology · 14d