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

157 results for "Tuv Rheinland of North America, Inc."
25–48 of 157
Search insights Median review: 15d Cleared: 100% Top manufacturer: Ge Medical Systems, Inc. Lead specialty: Radiology
Cleared Oct 31, 2008
MODIFICATION TO CHILLBUSTER PORTABLE ELECTRIC BLANKET , MODEL 8002
K083135 · DWJ
Thermogear, Inc.
Cardiovascular · 8d
Cleared Oct 27, 2008
KING`YIELD WRIST BLOOD PRESSURE MONITOR, MODEL BP201
K083043 · DXN
Shenzhen Kingyield Technology Co., Ltd.
Cardiovascular · 13d
Cleared Sep 30, 2008
IMAGENET PROFESSIONAL PC SOFTWARE SYSTEM OR IMAGENET PROFESSIONAL, OR...
K082364 · NFJ
Topcon Corp.
Ophthalmic · 43d
Cleared Sep 09, 2008
MODIFICATION TO SUPEROPEN 0.23T MRI SYSTEM, MODEL NAM-P023A
K082485 · LNH
Neusoft Medical Systems Co., Ltd.
Radiology · 12d
Cleared Aug 21, 2008
ANYRAY PORTABLE X-RAY SYSTEM
K081899 · EHD
E-Woo Technology Co., Ltd.
Radiology · 49d
Cleared Aug 21, 2008
PICASSO MASTER, ECT AND MASTER 3D
K081847 · JAK
E-Woo Technology
Radiology · 52d
Cleared Jul 15, 2008
ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1
K081843 · LLZ
Aloka Co., Ltd.
Radiology · 15d
Cleared Mar 13, 2008
NEUSOFT SPIRAL CT SCANNER SYSTEM, MODEL NEUVIZ VERSION 2.0
K080540 · JAK
Neusoft Medical Systems Co., Ltd.
Radiology · 15d
Cleared Feb 29, 2008
ALOKA PROSOUND 6 DIAGNOSTIC ULTRASOUND SYSTEM
K080176 · IYN
Aloka Co., Ltd.
Radiology · 36d
Cleared Feb 21, 2008
PRIMEVUE 21 3MP COLOR DISPLAY, MODEL AC-QX21-A9300
K080320 · LLZ
Nds Surgical Imaging
Radiology · 15d
Cleared Jan 04, 2008
BRAINSTAT SOFTWARE OPTION FOR GE SIGNA MR SCANNER
K073167 · LNH
Ge Medical Systems, LLC
Radiology · 56d
Cleared Nov 09, 2007
CHILLBUSTER PORTABLE ELECTRIC BLANKET, MODEL 8002
K071918 · DWJ
Thermogear, Inc.
Cardiovascular · 120d
Cleared Nov 01, 2007
IDEAL SOFTWARE OPTION FOR GE MR SCANNERS
K072998 · LNH
Ge Medical Systems, LLC
Radiology · 8d
Cleared Oct 16, 2007
NEUVIZ SPIRAL CT SCANNER SYSTEM
K072841 · JAK
Neusoft Medical Systems Co., Ltd.
Radiology · 12d
Cleared Aug 30, 2007
ALOKA SSD-ALPHA 7 ULTRASOUND SYSTEM
K072285 · ITX
Aloka Co., Ltd.
Radiology · 14d
Cleared Aug 24, 2007
CHISON, MODEL 8300
K072210 · IYO
Chison Medical Imaging Co., Ltd.
Radiology · 15d
Cleared Aug 14, 2007
NEOGUIDE ENDOSCOPY SYSTEM
K070622 · FDF
Neoguide Systems, Inc.
Gastroenterology & Urology · 161d
Cleared Jul 05, 2007
GE OEC ALTITUDE
K071717 · IZI
Shimadzu Corp.
Radiology · 13d
Cleared Jun 29, 2007
CERADRILL
K071352 · EJL
Gebr. Brasseler GmbH & Co. KG
Dental · 45d
Cleared Jun 26, 2007
MASSAGE MATTRESS VM9100RM
K070672 · JFB
Metek GmbH
Physical Medicine · 106d
Cleared May 10, 2007
SUPERSTAR 0.35T MRI SYSTEM
K071154 · LNH
Neusoft Medical Systems Co., Ltd.
Radiology · 15d
Cleared Mar 23, 2007
BP 101 DIGITAL BLOOD PRESSURE MONITOR
K062033 · DXN
Kingyield Hongkong Limited
Cardiovascular · 248d
Cleared Oct 06, 2006
RTVUE
K062552 · OBO
Optovue, Inc.
Ophthalmic · 37d
Cleared Oct 04, 2006
SMARTSUCTION SOLO DEVICE
K062801 · BTA
Haemonetics Corp.
General & Plastic Surgery · 15d