FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

681 results for "regulatory technology services, llc"
529–552 of 681
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 20, 2009
ENCOR BREAST BIOPSY SYSTEM
K093512 · KNW
Senorx, Inc.
Gastroenterology & Urology · 7d
Cleared Nov 06, 2009
TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM
K093301 · MCW
Ev3, Inc.
Cardiovascular · 16d
Cleared Nov 06, 2009
DX-D IMAGING PACKAGE
K092669 · MQB
Agfa Healthcare N.V.
Radiology · 67d
Cleared Oct 09, 2009
APLIO MX SSA-780A, VERSION 1.0
K092948 · IYN
Toshiba America Medical Systems, In.C
Radiology · 15d
Cleared Oct 08, 2009
ENGAGE/ENGAGE TR
K092575 · DYB
St Jude Medical
Cardiovascular · 48d
Cleared Sep 18, 2009
ABVS WORKPLACE
K092067 · LLZ
Siemens AG Medical Solutions
Radiology · 71d
Cleared Aug 19, 2009
CONTURA CAVITY MAINTENANCE CATHETER
K092323 · JAQ
Senorx, Inc.
Radiology · 15d
Cleared Aug 11, 2009
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERS
K092238 · MQB
Agfa Healthcare N.V.
Radiology · 19d
Cleared Aug 07, 2009
TRAILBLAZER SUPPORT CATHETER
K092299 · DQY
Ev3, Inc.
Cardiovascular · 9d
Cleared Jul 29, 2009
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 4.0R001
K092179 · IYN
Toshiba America Medical Systems, In.C
Radiology · 8d
Cleared Jul 17, 2009
CX50 VERSION 2.0 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS
K091804 · ITX
Philips Ultrasound, Inc.
Radiology · 29d
Cleared Jul 09, 2009
LITHO LASER SYSTEM
K091909 · GEX
Quanta System Spa
General & Plastic Surgery · 14d
Cleared Jun 24, 2009
GE LIGHTSPEED ACT FP16
K091673 · JAK
Ge Medical Systems, Inc.
Radiology · 15d
Cleared Jun 19, 2009
CYBER SURGICAL LASER FAMILY INCLUDING: CYBER TM, CYBER GREEN, CYBER GREEN TM
K090962 · GEX
Quanta System Spa
General & Plastic Surgery · 74d
Cleared Jun 05, 2009
VITREA ENDOVASCULAR STENT PLANNING SOFTWARE
K091498 · LLZ
Vital Images, Inc.
Radiology · 16d
Cleared Jun 04, 2009
R2 DIGITALNOW HD(DIGITALNOW HD)
K091368 · LLZ
Hologic, Inc.
Radiology · 27d
Cleared May 18, 2009
MY LABS25 GOLD/MYLAB30 GOLD CARDIOVASCULAR MODEL 7340, MY LAB70/MY...
K091009 · IYN
Esaote, S.P.A.
Radiology · 39d
Cleared May 18, 2009
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS
K090672 · MQB
Agfa Healthcare N.V.
Radiology · 66d
Cleared May 15, 2009
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM MODEL SSA-790A VERSION 4.0
K091295 · ITX
Toshiba America Medical Systems, In.C
Radiology · 11d
Cleared May 15, 2009
SYNGO US WORKPLACE
K091286 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 14d
Cleared Apr 22, 2009
ULTIMUM/ENGAGE/ENGAGE TR
K091137 · DYB
St Jude Medical
Cardiovascular · 2d
Cleared Apr 15, 2009
TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER
K082997 · FOZ
Terumo Medical Corp.
General Hospital · 189d
Cleared Mar 25, 2009
FORUM
K090439 · NFJ
Carl Zeiss Meditec, Inc.
Ophthalmic · 33d
Cleared Mar 05, 2009
CSBP-001A BODY PERFUSION SYSTEM
K090504 · JAK
Toshibamedical Systems Corporation
Radiology · 7d