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

1,198 results for "regulatory technology services, llc"
1105–1128 of 1,198
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jun 22, 2006
NEMIO XG, SAA-580A
K061605 · IYN
Toshiba America Medical Systems, In.C
Radiology · 13d
Cleared Jun 21, 2006
DEFIBRILLATOR CABLE TESTER, MODEL DT2200
K061606 · DRG
Medical Devices/Padpro, Inc.
Cardiovascular · 12d
Cleared May 31, 2006
INSPIRSTAR GLOVE ELECTRODE
K061343 · GXY
Inspirstar, Inc.
Neurology · 16d
Cleared May 30, 2006
QLAB QUANTIFICATION SOFTWARE
K061396 · LLZ
Philips Ultrasound, Inc.
Radiology · 11d
Cleared May 16, 2006
SONOACE PICO DIAGNOSTIC ULTRASOUND SYSTEM
K061213 · IYN
Medison Co., Ltd.
Radiology · 14d
Cleared May 12, 2006
TSX-201A, AQUILION LB CT SCANNER WITH RESPIRATORY GATING
K061187 · JAK
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared May 10, 2006
MUCHECK V7.0
K061152 · LHN
Oncology Data Systems, Inc.
Radiology · 14d
Cleared May 04, 2006
BABYBEAT CORDLESS
K061091 · KNG
The Newman Group, LLC
Radiology · 15d
Cleared Apr 28, 2006
SYNGO US WORKPLACE
K060992 · LLZ
Siemens Medical Solutions
Radiology · 17d
Cleared Apr 07, 2006
SEEKER/SPARK ULTRASOUND SYSTEM
K060800 · IYO
Ardent Sound, Inc.
Radiology · 14d
Cleared Apr 04, 2006
XPERCT
K060749 · IZI
Philips Medical Systems North America...
Radiology · 15d
Cleared Mar 31, 2006
ONE STICK Y EXTENSION SET AND VOLUMETER
K060672 · FPA
One Stick, LLC
General Hospital · 17d
Cleared Mar 14, 2006
INSPIRSTAR IS02 MICROCURRENT STIMULATOR
K060368 · GZJ
Inspirstar, Inc.
Neurology · 29d
Cleared Mar 09, 2006
AZE VIRTUALPLACE
K060453 · LLZ
Aze, Ltd.
Radiology · 15d
Cleared Mar 09, 2006
VITREA2 VERSION 3.8.1
K060378 · LLZ
Vital Images, Inc.
Radiology · 23d
Cleared Mar 03, 2006
BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM
K060277 · JCX
Boehringer Laboratories
General & Plastic Surgery · 29d
Cleared Jan 24, 2006
ACCUVIX V7 DIAGNOSTIC ULTRASOUND SYSTEM
K060087 · IYN
Medison Co., Ltd.
Radiology · 12d
Cleared Jan 18, 2006
EXCELART VANTAGE ZGV
K060003 · LNH
Toshibamedical Systems Corporation
Radiology · 15d
Cleared Jan 03, 2006
SONOACE X4 DIAGNOSTIC ULTRASOUND SYSTEM
K053530 · IYN
Medison Co., Ltd.
Radiology · 15d
Cleared Dec 30, 2005
COMMANDER III NON-INVASIVE BLOOD PRESSURE SYSTEM
K053304 · DXN
Cardiocom, LLC
Cardiovascular · 32d
Cleared Dec 30, 2005
CARDIOCOM COMMANDER III
K053303 · DXN
Cardiocom, LLC
Cardiovascular · 32d
Cleared Dec 28, 2005
VAX-D GENESIS SYSTEM (THERAPEUTIC TABLE)
K053503 · ITH
Vax-D Medical Technologies USA, L.C.
Physical Medicine · 12d
Cleared Dec 20, 2005
THERAKNIT GARMENT ELECTRODE
K053214 · GXY
Neurotron Medical
Neurology · 33d
Cleared Dec 16, 2005
WARMING LIQUID PERSONAL LUBRICANT
K052974 · NUC
Pharmapac, LLC
Obstetrics & Gynecology · 53d