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"
97–120 of 335
Search insights Median review: 15d Cleared: 100% Top manufacturer: Aloka Co., Ltd. Lead specialty: Radiology
Cleared Oct 08, 2008
RTX RESPIRATOR
K082657 · BYT
Medivent Limited
Anesthesiology · 26d
Cleared Oct 01, 2008
MEDX LPT 200 TETHERED LASER & MEDX LPS 200 (ORALASE) PORTABLE LASER
K082707 · ILY
Medx Electronics, Inc.
Physical Medicine · 15d
Cleared Sep 25, 2008
AW SERVER
K081985 · LLZ
Ge Medical Systems, LLC
Radiology · 73d
Cleared Sep 10, 2008
BEAMER ARGON PROBE
K081644 · GEI
Conmed Corporation
General & Plastic Surgery · 90d
Cleared Sep 08, 2008
COMPUMEDICS NEUVO
K081151 · GWQ
Compumedics USA, Ltd.
Neurology · 138d
Cleared Sep 02, 2008
GE LIGHTSPEED RT16 / LIGHTSPEED XTRA V2 CT SYSTEM (AKA GE LIGHTSPEED RT16 /...
K082104 · JAK
Ge Medical Systems, Inc.
Radiology · 39d
Cleared Aug 26, 2008
VOLUMINA
K081215 · LLZ
Kjaya Medical, LLC
Radiology · 118d
Cleared Aug 22, 2008
WESTAR SERIES DENTAL UNITS
K082294 · EIA
Westar Medical Products, Inc.
Dental · 10d
Cleared Aug 20, 2008
BIOGENICS BIOQUAD 4-WELL IVF CULTURE DISH
K081896 · MQK
Biogenics, Inc.
Obstetrics & Gynecology · 48d
Cleared Aug 06, 2008
ALLTECH ECHOSTAR 1.5 T MR SYSTEM
K082100 · LNH
Alltech Medical Systems America, Inc.
Radiology · 12d
Cleared Jul 22, 2008
GE SIGNA MR ONCOLOGY PACKAGE
K081916 · LNH
Ge Medical Systems, LLC
Radiology · 15d
Cleared Jul 16, 2008
AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER
K081841 · ETY
Amplivox, Ltd.
Ear, Nose, Throat · 16d
Cleared Jul 15, 2008
ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP
K081905 · MEB
Westmed, Inc.
General Hospital · 12d
Cleared Jul 11, 2008
ICI P AND S SERIES IR CAMERAS
K073581 · LHQ
Texas Infrared
Radiology · 204d
Cleared Jun 25, 2008
CONMED GOLDVAC INTEGRATED SMOKE EVACUATION PENCIL
K081634 · GEI
Conmed Corporation
General & Plastic Surgery · 14d
Cleared Jun 23, 2008
SHARPS TRANSPORT TUBE, MODEL 50035
K073577 · MMK
Sharps Compliance, Inc.
General Hospital · 186d
Cleared Jun 19, 2008
BEAMER ARGON SNARE PROBE
K081580 · GEI
Conmed Corporation
General & Plastic Surgery · 14d
Cleared Jun 12, 2008
OPTIMA PET/CT 560
K081496 · KPS
Ge Medical Systems, LLC
Radiology · 14d
Cleared Jun 03, 2008
SOFIA AUTOMATED TOMOGRAPHIC ULTRASOUND (ATUS)
K080555 · ITX
Ivu Imaging Corporation
Radiology · 96d
Cleared May 28, 2008
ILUMA VISION
K081347 · LLZ
Imtec Corp.
Radiology · 14d
Cleared May 20, 2008
OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY)
K081281 · MUJ
Nucletron Corporation
Radiology · 14d
Cleared May 20, 2008
CONMED AXCESS PAPILLOTOME MODELS AX4535, AX4535FX
K080946 · KNS
Conmed Endoscopic Technologies, Inc.
Gastroenterology & Urology · 47d
Cleared May 15, 2008
ZIRDENT CAD/CAM BLOCKS
K081253 · EIH
C5 Medical Werks, Inc.
Dental · 13d
Cleared May 14, 2008
REINFORCED CATHETER INTRODUCER SYSTEM (RCIS)
K081341 · DYB
Thomas Medical Products, Inc.
Cardiovascular · 1d