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"
817–840 of 1,198
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 16, 2010
THE SONOACE R3 DIAGNOSTIC ULTRASOUND SYSTEM
K101829 · ITX
Medison Co., Ltd.
Radiology · 15d
Cleared Jul 01, 2010
CERULEAU ELECTROSURGICAL PROBE
K101711 · GEI
Nuortho Surgical, Inc.
General & Plastic Surgery · 13d
Cleared Jul 01, 2010
NEV'S INK AUTOCLAVE TAPES
K101580 · JOJ
Nev'S Ink, Inc.
General Hospital · 24d
Cleared Jun 17, 2010
CIRCUFLOW 5200 SEQUENTIAL COMPRESSION DEVICE
K101523 · JOW
Devon Medical, Inc.
Cardiovascular · 15d
Cleared Jun 03, 2010
BD INTIMA II CLOSED IV CATHETER
K100775 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 77d
Cleared Jun 03, 2010
HOTDOG MULTI FUNCTION CONTROLLER
K094056 · DWJ
Augustine Biomedical & Design, LLC
Cardiovascular · 154d
Cleared May 14, 2010
MRI PATIENT POSITIONING DEVICES
K093738 · LNH
Medtec, Inc.
Radiology · 161d
Cleared May 06, 2010
A.B. KORKOR MEDICAL SKINNYSAFE INTRODUCER SHEATH
K092097 · DYB
A.B. Korkor Medical, Inc.
Cardiovascular · 296d
Cleared Apr 28, 2010
ROLL-X GUIDEWIRE
K100710 · DQX
St Jude Medical
Cardiovascular · 47d
Cleared Mar 24, 2010
MYSONO U5 DIAGNOSTIC ULTRASOUND SYSTEM
K100186 · IYN
Medison Co., Ltd.
Radiology · 61d
Cleared Mar 17, 2010
MODEL VISULAS 532S LASER WITH THE VITE OPTION
K100035 · GEX
Carl Zeiss Meditec, AG
General & Plastic Surgery · 70d
Cleared Mar 05, 2010
CIRCUFLOW 5100 SEQUENTIAL COMPRESSION DEVICE
K100446 · JOW
Devon Medical, Inc.
Cardiovascular · 16d
Cleared Mar 05, 2010
CUATTRO UNOMD
K093480 · LLZ
Cuattro, LLC
Radiology · 116d
Cleared Mar 03, 2010
ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM
K093812 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 82d
Cleared Feb 26, 2010
TRAILRUNNER GUIDEWIRES
K092965 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 154d
Cleared Feb 25, 2010
ENSITE VELOCITY SYSTEM V1.3
K093942 · DQK
St Jude Medical
Cardiovascular · 65d
Cleared Feb 01, 2010
IU22 ULTRASOUND SYSTEM AND TRANSDUCERS
K093563 · IYN
Philips Ultrasound, Inc.
Radiology · 75d
Cleared Jan 28, 2010
MODEL VIAMO SSA-640A, VERSION 2.0 ULTRASOUND SYSTEM
K100067 · ITX
Toshiba America Medical Systems, In.C
Radiology · 17d
Cleared Jan 28, 2010
DOCKING STATION,TEIRSTEIN EDGE,ANGIOASSIST COMBINATION DEVICE, ANGIOASSIST...
K093822 · DQX
Shepherd Scientific, Inc.
Cardiovascular · 45d
Cleared Jan 19, 2010
ACCUVIX V10 DIAGNOSTIC ULTRASOUND SYSTEM
K093849 · IYN
Medison Co., Ltd.
Radiology · 34d
Cleared Dec 23, 2009
VASCUVIEW TAP ULTRASOUND SYSTEM
K093613 · IYN
Escalon Medical Corp.
Radiology · 30d
Cleared Dec 18, 2009
SMARTWAND-DTX
K093557 · LWH
Clearcount Medical Solutions
General & Plastic Surgery · 32d
Cleared Dec 17, 2009
ARP RX100
K093259 · IPF
Arp Manufacturing, Inc.
Physical Medicine · 59d
Cleared Dec 15, 2009
EP -NURSEMATE, EP -NURSEMATE WITH PHYSIO MODULE
K093583 · DQK
St Jude Medical
Cardiovascular · 26d