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"
937–960 of 1,198
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 12, 2008
AARDVARK NASAL IRRIGATION AND ASPIRATION DEVICE
K082762 · JCX
Aardvark Medical
General & Plastic Surgery · 51d
Cleared Nov 07, 2008
1.5T ATLAS SPEEDER HEAD-NECK COIL
K083160 · MOS
Quality Electrodynamics
Radiology · 11d
Cleared Nov 06, 2008
AGILIS NXT STEERABLE INTRODUCER
K083083 · DYB
St Jude Medical
Cardiovascular · 21d
Cleared Oct 31, 2008
SONIXTOUCH ULTRASOUND SYSTEM
K083095 · IYN
Ultrasonix Medical Corporation
Radiology · 14d
Cleared Oct 24, 2008
TWINLOTUS AND SHIELDS NATURAL RUBBER LATEX CONDOM
K081413 · HIS
Dailian Latex Company, Ltd.
Obstetrics & Gynecology · 157d
Cleared Oct 17, 2008
ATLAS SPEEDER HEAD/CERVICAL COIL, MODEL MJAH-137A
K083014 · MOS
Toshiba America Medical Systems, In.C
Radiology · 8d
Cleared Oct 17, 2008
P3T ABDOMEN
K082458 · JAK
Medrad, Inc.
Radiology · 52d
Cleared Oct 14, 2008
4D VIEWER RADIOLOGY, MODEL USWP-100A
K082684 · LLZ
Toshiba America Medical Systems, In.C
Radiology · 29d
Cleared Oct 10, 2008
INFX-8000H, INFINIX-I
K082830 · JAA
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Oct 08, 2008
ZONARE ULTRA ULTRASOUND SYSTEM
K082326 · IYN
Zonare Medical Systems, Inc.
Radiology · 55d
Cleared Oct 07, 2008
JUMAO MANUAL WHEELCHAIR
K082784 · IOR
Danyang Jumao Healthcare Equipment...
Physical Medicine · 14d
Cleared Sep 26, 2008
FINECROSS MG CORONARY MICRO-GUIDE CATHETER
K082519 · KRA
Terumo Medical Corp.
Cardiovascular · 24d
Cleared Sep 25, 2008
TXRX 15CH KNEE COIL (1.5T AND 3T), TXRX CP EXTREMITY COIL 3T
K082636 · MOS
Quality Electrodynamics
Radiology · 15d
Cleared Sep 25, 2008
MODEL 6150 (MYLAB70) AND MODEL 6100 (MYLAB90)
K081386 · IYN
Esaote, S.P.A.
Radiology · 129d
Cleared Sep 24, 2008
RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER
K082736 · DQO
Terumo Medical Corp.
Cardiovascular · 6d
Cleared Sep 23, 2008
ULTRAEXTEND USWS-900A
K082596 · LLZ
Toshiba America Medical Systems, In.C
Radiology · 15d
Cleared Sep 18, 2008
GLIDESHEATH
K082644 · DYB
Terumo Medical Corp.
Cardiovascular · 7d
Cleared Sep 18, 2008
ENTELLUS MEDICAL FLEXIBLE ENDOSCOPE AND EYEPIECE
K082569 · EOB
Entellus Medical, Inc.
Ear, Nose, Throat · 13d
Cleared Sep 17, 2008
ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE MODEL HBPK-A
K082542 · DXQ
Cardicare Company, Ltd.
Cardiovascular · 14d
Cleared Sep 17, 2008
SURSHIELD SAFETY I.V. CATHETER
K082362 · FOZ
Terumo Medical Corp.
General Hospital · 30d
Cleared Sep 12, 2008
DRAD3000E/RADREX-I
K082494 · MQB
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Sep 12, 2008
QUANTRA
K082483 · LLZ
Hologic, Inc.
Radiology · 15d
Cleared Sep 12, 2008
CONTURA LUMEN MARKER
K082264 · JAQ
Senorx, Inc.
Radiology · 32d
Cleared Sep 11, 2008
ENSITE FUSION DYNAMIC REGISTRATION TOOL
K082467 · DQK
St Jude Medical
Cardiovascular · 15d