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."
1–24 of 157
Search insights Median review: 15d Cleared: 100% Top manufacturer: Ge Medical Systems, Inc. Lead specialty: Radiology
Cleared Apr 12, 2013
PROUSOUND ALPHA 7 VER. 6.0 DIAGNOSTIC ULTRASOUND SYSTEM MODEL: PROSOUND ALPHA...
K122537 · IYN
Hitachi Aloka Medical,Ltd. (Hitachi...
Radiology · 235d
Cleared Sep 26, 2012
PROSOUND F37 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL: PROSOUND F37
K122341 · IYN
Hitachi Aloka Medical, Ltd.
Radiology · 55d
Cleared Aug 02, 2012
SONOTOUCH SERIES DIAGNOSTIC ULTRASOUND SYSTEMS
K121867 · IYN
Chison Medical Imaging Co., Ltd.
Radiology · 37d
Cleared Feb 10, 2012
KINGYIELD WRIST BLOOD PRESSURE MONITOR
K112042 · DXN
Shenzhen Kingyield Technology Co., Ltd.
Cardiovascular · 207d
Cleared Aug 08, 2011
CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES
K111047 · OWN
Mauna Kea Technologies, Inc.
General & Plastic Surgery · 115d
Cleared May 13, 2011
ALOKA SSD-3500 DIAGNOSTIC ULTRASOUND SYSTEM
K111227 · IYN
Aloka Co., Ltd.
Radiology · 11d
Cleared Apr 05, 2011
INTEGRITY SPINAL CARE SYSTEM
K103248 · ITH
Integra Life Sciences
Physical Medicine · 153d
Cleared Feb 17, 2011
ALOKA PROUSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM
K110207 · IYN
Aloka Co., Ltd.
Radiology · 23d
Cleared Jul 21, 2010
SUPRA SCAN DELIVERY SYSTEM
K100678 · GEX
Quantel Medical
General & Plastic Surgery · 133d
Cleared Jul 01, 2010
IP-SET
K101685 · DRX
Integral Process Sas
Cardiovascular · 15d
Cleared May 06, 2010
STRYKER SWITCHPOINT INFINITY 3 CONTROL SYSTEM, MODEL: 067-8001-000
K100852 · OCS
Stryker Communications
Gastroenterology & Urology · 41d
Cleared Dec 02, 2009
SYNERGY
K093313 · NFJ
Topcon Medical Systems, Inc.
Radiology · 41d
Cleared Nov 20, 2009
ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEM
K093488 · IYO
Aloka Co., Ltd.
Radiology · 10d
Cleared Sep 22, 2009
NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM
K092742 · JAK
Neusoft Medical Systems Co., Ltd.
Radiology · 14d
Cleared Sep 09, 2009
NSM-S15 SYSTEM
K092237 · LNH
Neusoft Medical Systems Co., Ltd.
Radiology · 48d
Cleared Aug 06, 2009
BEYONDIMAGE WORKSTATION
K092235 · LLZ
Neusoft Medical Systems Co., Ltd.
Radiology · 14d
Cleared Jun 30, 2009
RETINA CAMERA TRC-NW7SF MARK II
K090115 · HKI
Topcon Corp.
Ophthalmic · 160d
Cleared Jun 16, 2009
SUPRA 577.Y LASER
K091581 · HQF
Quantel Medical
Ophthalmic · 14d
Cleared Apr 02, 2009
ATMOS S041 WOUND
K090130 · OMP
Atmos, Inc.
General & Plastic Surgery · 71d
Cleared Feb 27, 2009
ATMOS C361/C451 SUCTION PUMP
K090445 · BTA
Atmos, Inc.
General & Plastic Surgery · 7d
Cleared Feb 05, 2009
NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM
K090173 · JAK
Neusoft Medical Systems Co., Ltd.
Radiology · 13d
Cleared Jan 13, 2009
FLYING DIAGNOSTIC ULTRASOUND SYSTEM
K083877 · ITX
Neusoft Medical Systems Co., Ltd.
Radiology · 15d
Cleared Dec 19, 2008
ALOKA PROUSOUND 2 DIAGNOSTIC ULTRASOUND SYSTEM
K083254 · IYN
Aloka Co., Ltd.
Radiology · 45d
Cleared Nov 21, 2008
16CH AI BREAST COILS 1.5 T AND 3 T
K083255 · MOS
Rapid Biomedical GmbH
Radiology · 17d