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"
985–1008 of 1,198
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jun 06, 2008
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A, VERSION 2.2
K081065 · IYN
Toshiba America Medical Systems, In.C
Radiology · 52d
Cleared Jun 03, 2008
ULTIGUARD HOME INSULIN PEN NEEDLE DISPENSER AND SHARPS CONTAINER
K081449 · MMK
Ultimed, Inc.
General Hospital · 11d
Cleared May 30, 2008
COLUMBIA 600 ELECTRODE, COLUMBIA 06 LEADWIRE
K080386 · GXY
Columbia Scientific Development, LLC
Neurology · 107d
Cleared May 02, 2008
CONTURA MLB SOURCE APPLICATOR FOR BRACHYTHERAPY
K081079 · JAQ
Senorx, Inc.
Radiology · 16d
Cleared May 01, 2008
3-D IMAGING WORKSTATION
K081093 · LLZ
Eigen, LLC
Radiology · 14d
Cleared Apr 30, 2008
CONTURA MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRACHYTHERAPY, MODELS...
K080791 · JAQ
Senorx, Inc.
Radiology · 41d
Cleared Apr 24, 2008
MEDDORNA WIRELESS PRN SPIROMETER 100
K072722 · BZG
Meddorna, LLC
Anesthesiology · 211d
Cleared Apr 17, 2008
TRAXCESS 0.014 HYDROPHILIC GUIDEWIRE
K080863 · DQX
MicroVention, Inc.
Cardiovascular · 20d
Cleared Apr 11, 2008
QHRV 1 - HEALTH ASSESSMENT SYSTEM
K080884 · DPS
Medtechs, LLC
Cardiovascular · 11d
Cleared Apr 07, 2008
ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEM
K080800 · IYN
Medison Co., Ltd.
Radiology · 17d
Cleared Apr 03, 2008
MODEL D DISC FORCE
K073132 · ITH
North American Medical Corp (Nam)
Physical Medicine · 148d
Cleared Apr 02, 2008
TEM 3002G- HN DUAL TUNE HEAD COIL
K080820 · MOS
Mr Instruments, Inc.
Radiology · 9d
Cleared Mar 27, 2008
HD7 DIAGNOSTIC ULTRASOUND SYSTEM
K080548 · IYN
Phillips Medical Systems
Radiology · 28d
Cleared Mar 27, 2008
AIRISTAR AIR PURIFICATION SYSTEM, MODEL 500 & 1000
K072185 · FRF
Airistar Technologies, LLC
General Hospital · 234d
Cleared Mar 24, 2008
MODELS TENS 7000, EMS 7500 AND TWIN STIM
K080661 · IPF
Koalaty Products, Inc.
Physical Medicine · 14d
Cleared Mar 24, 2008
MODEL TW SB, SCALP VEIN SET
K073705 · FMI
Shandong Qiaopai Group Co., Ltd.
General Hospital · 84d
Cleared Mar 19, 2008
LED.L, LED.M, LED.G, LED.B
K080025 · EBZ
Guilin Woodpecker Medical Instrument...
Dental · 75d
Cleared Mar 14, 2008
MODEL TSX-101A/H/I AQUILION 32/64 SP CT SYSTEM
K080211 · JAK
Toshiba America Medical Systems, In.C
Radiology · 45d
Cleared Mar 11, 2008
ATRICURE COOLRAIL LINEAR PEN
K073605 · OCL
AtriCure, Inc.
Cardiovascular · 81d
Cleared Feb 29, 2008
HEART SYNC, MODELS C-100 AND T-100
K080421 · MKJ
Heart Sync, LLC
Cardiovascular · 14d
Cleared Feb 28, 2008
Q-PLUS T
K073549 · GEX
Quanta System Spa
General & Plastic Surgery · 72d
Cleared Feb 20, 2008
VITREA 4DCT
K072821 · LLZ
Vital Images, Inc.
Radiology · 141d
Cleared Feb 14, 2008
TERASON ECHO T/3000 ULTRASOUND SYSTEM WITH STRESS ECHO
K080234 · IYO
Teratech Corp.
Radiology · 15d
Cleared Feb 08, 2008
APLIO ARTIDA, MODEL SSH-880CV DIAGNOSTIC ULTRASOUND SYSTEM
K080160 · IYN
Toshiba America Medical Systems, In.C
Radiology · 16d