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"
769–792 of 1,198
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Apr 08, 2011
NICOLET WIRELESS EEG
K103140 · GWL
Carefusion 209, Inc.
Neurology · 165d
Cleared Apr 05, 2011
SHARPS CONTAINER
K110262 · MMK
Noble Marketing
General Hospital · 67d
Cleared Apr 05, 2011
REVERSE MEDICAL REFLEX GUIDE CATHETER
K110055 · DQY
Reverse Medical Corporation
Cardiovascular · 85d
Cleared Apr 04, 2011
SOUND SURGICAL TECHNOLOGIES LLC POWERX LIPO SYSTEM
K110255 · QPB
Sound Surgical Technologies, LLC
General & Plastic Surgery · 66d
Cleared Mar 29, 2011
MC 1504G-16R, 1.5T, 16-CHANNEL, MC 3004G-16R, 3.0T, 16-CHANNEL HEAD COIL
K110591 · MOS
Mr Instruments, Inc.
Radiology · 27d
Cleared Mar 17, 2011
ENCOMPASS HF100- EAGLE PANORAMIC/CEPHALOMETRIC X-RAY
K110371 · MUH
Panoramic Corp.
Radiology · 37d
Cleared Mar 16, 2011
PLUMEPEN INTEGRATED SMOKE EVACUATION PENCIL
K103375 · GEI
Medtek Devices, Inc.
General & Plastic Surgery · 120d
Cleared Mar 11, 2011
E4D COMPASS
K110511 · LLZ
D4D Technologies
Radiology · 16d
Cleared Mar 10, 2011
AIRSTRIP REMOTE PATIENT MONITORING (RPM)
K110503 · MWI
Airstrip Technologies, LP
Cardiovascular · 16d
Cleared Feb 25, 2011
ACCUVIX XG DIAGNOSTIC ULTRASOUND SYSTEM
K103397 · IYN
Medison Co., Ltd.
Radiology · 98d
Cleared Feb 25, 2011
TOSHIBA 1.5T EXTRA LARGE KNEE COIL
K103185 · MOS
Quality Electrodynamics
Radiology · 120d
Cleared Feb 24, 2011
BILLY BOY MALE LATEX CONDOM
K103119 · HIS
Sheila Pickering PHD
Obstetrics & Gynecology · 125d
Cleared Feb 08, 2011
FUJIFILM DIAGNOSTIC ULTRASOUND SYSTEM FAZONE CB
K110202 · ITX
Fujifilm Medical System U.S.A., Inc.
Radiology · 15d
Cleared Feb 02, 2011
FINESS ENDOSCOPE STERILIZATION TRAY
K103213 · KCT
Entellus Medical, Inc.
General Hospital · 93d
Cleared Jan 26, 2011
VANTAGE VIEW SYSTEM
K110085 · DXJ
St Jude Medical
Cardiovascular · 15d
Cleared Jan 25, 2011
Q-STATION
K103815 · LLZ
Philips Ultrasound, Inc.
Radiology · 27d
Cleared Jan 20, 2011
QUANTA SYSTEM DUOLITE
K103539 · GEX
Quanta System Spa
General & Plastic Surgery · 49d
Cleared Jan 05, 2011
THE SONOACE R5 DIAGNOSTIC ULTRASOUND SYSTEM
K103722 · ITX
Medison Co., Ltd.
Radiology · 15d
Cleared Jan 05, 2011
TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM
K103618 · MCW
Ev3, Inc.
Cardiovascular · 26d
Cleared Jan 05, 2011
GLIDERXTREME PTA BALLOON CATHETER (CB) (OVER THE WIRE) 0.014 / 0.018 GUIDE WIRE
K103534 · DQY
Trireme Medical, Inc.
Cardiovascular · 35d
Cleared Jan 04, 2011
YOBOSHI DENTAL UNIT
K103550 · EIA
Fosham Yoboshi Medical Equipment Co.,...
Dental · 32d
Cleared Jan 03, 2011
DX-D 100
K103597 · IZL
Agfa Healthcare N.V.
Radiology · 26d
Cleared Jan 03, 2011
TANDA MAX
K103415 · ONE
Pharos Life Corporation
General & Plastic Surgery · 42d
Cleared Dec 29, 2010
SAPPHIRE ST PORTABLE DIODE LASER
K103667 · GEX
Den-Mat Holdings, LLC
General & Plastic Surgery · 14d