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"
25–48 of 335
Search insights Median review: 15d Cleared: 100% Top manufacturer: Aloka Co., Ltd. Lead specialty: Radiology
Cleared Sep 19, 2011
PROCEDURAL STRECHER WITH INTELLIDRIVE P8000
K112502 · INK
Hill-Rom Co.
Physical Medicine · 20d
Cleared Aug 30, 2011
MONICA IF24
K112163 · OSP
Monica Healthcare
Obstetrics & Gynecology · 34d
Cleared Aug 17, 2011
GLIDERXTREME PTA BALLON CATHETER (OVER THE WIRE) 0.018 GUIDE WIRE 6100-XXXXX,...
K112281 · DQY
Trireme Medical, Inc.
Cardiovascular · 8d
Cleared Jul 14, 2011
SOFT GRIP CONTACT LENS CASE, DELUXE CONTACT LENS CASE, ECONO-MATE CONTACT...
K111856 · LRX
Apothecary Products, Inc.
Ophthalmic · 15d
Cleared Jul 08, 2011
RHA2020
K111531 · HLI
Annidis Health Systems Corp.
Ophthalmic · 36d
Cleared Jun 21, 2011
ANASCIENT BREATH MONITOR
K110810 · BZL
Invoy Technologies, LLC
Anesthesiology · 90d
Cleared May 13, 2011
CLICK-IT
K111234 · NJM
Tp Orthodontics, Inc.
Dental · 11d
Cleared May 05, 2011
RELYX LUTING PLUS AUTOMIX
K111185 · EMA
3M Espe Dental Products
Dental · 8d
Cleared Apr 28, 2011
GN OTOMETRICS TYPE 1053 FREEFIT
K110286 · ETW
Gn Otometrics A/S
Ear, Nose, Throat · 87d
Cleared Mar 31, 2011
SIMPLICLEAR RECTANGULAR ORTHODONTIC WIRE
K110796 · DYW
Biomers Products, LLC
Dental · 9d
Cleared Mar 30, 2011
GAUNYING INFRARED LAMP
K110721 · ILY
Foshan Gaunying Electronics Co., Ltd.
Physical Medicine · 15d
Cleared Mar 24, 2011
CLEARCANVAS RIS / PACS
K110332 · LLZ
Clearcanvas, Inc.
Radiology · 49d
Cleared Mar 24, 2011
BODYTOM NL 4000
K102677 · JAK
Neurologica Corporation
Radiology · 190d
Cleared Mar 14, 2011
UBM PLUS
K103471 · IYN
Accutome, Inc.
Radiology · 110d
Cleared Mar 11, 2011
TOMMEE TIPPEE CLOSER TO NATURE ELECTRIC BREAST PUMP
K110343 · HGX
Mayborn Baby and Child / Jackel...
Obstetrics & Gynecology · 35d
Cleared Feb 10, 2011
SPPHINE PLUS STM 3W DIODE LASER
K110079 · GEX
Den-Mat Holdings, LLC
General & Plastic Surgery · 30d
Cleared Feb 08, 2011
DEFIBRILLATOR ANALYZER - DA-2006P
K110192 · DRL
Bc Group International, Inc.
Cardiovascular · 15d
Cleared Jan 21, 2011
LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC / E4D, LAVA ULTIMATE IMPLANT...
K110131 · EBF
3M Espe Dental Products
Dental · 3d
Cleared Jan 12, 2011
EXPECT ENDOSCOPIC ASPIRATION NEEDLE
K110030 · ODG
Boston Scientific Corp
Gastroenterology & Urology · 7d
Cleared Dec 30, 2010
BNX FINE NEEDLE ASPIRATION SYSTEM
K103668 · FCG
Boston Endoscopic Engineering
Gastroenterology & Urology · 14d
Cleared Dec 16, 2010
IBED WIRELESS WITH IBED AWARENESS
K103536 · FNL
Stryker Corporation
General Hospital · 15d
Cleared Dec 10, 2010
VASCUCOMP
K103247 · JOW
Thermotek, Inc.
Cardiovascular · 37d
Cleared Dec 09, 2010
IMMULISA DSDNA ANTIBODY ELISA
K101319 · LRM
Immco Diagnostics, Inc.
Immunology · 212d
Cleared Nov 24, 2010
CONMED ALTRUS THERMAL TISSUE FUSION SYSTEM
K101534 · GEI
Conmedcorp
General & Plastic Surgery · 174d