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"
625–648 of 1,198
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 24, 2013
PERCUNAV SYSTEM
K132087 · JAK
Philips Health Care
Radiology · 19d
Cleared Jul 23, 2013
ESIE APPS SUITE
K132062 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 20d
Cleared Jul 23, 2013
ULTRAEXTEND USWS-900A V2.1 AND V3.1
K131822 · LLZ
Toshiba America Medical Systems, In.C
Radiology · 33d
Cleared Jul 12, 2013
MIPLATFORM MEDICAL IMAGING SUITE
K131424 · LLZ
Hinacom Software and Technology, Ltd.
Radiology · 56d
Cleared Jul 03, 2013
AIRSTRIP REMOTE PATIENT MONITORING PHILIPS ADAPTER
K131786 · MWI
Airstrip Technologies, LP
Cardiovascular · 15d
Cleared Jul 02, 2013
BLOWFISH TRANSBRONCHIAL MICRO-INFUSION CATHETER
K131401 · EOQ
Mercator Medsystems, Inc.
Ear, Nose, Throat · 48d
Cleared Jul 01, 2013
CIRONA DVT FOOT GARMENT
K131743 · JOW
Devon Medical, Inc.
Cardiovascular · 18d
Cleared Jun 25, 2013
TRACTUS TISSUEMAPPER IMAGE RECORDING SYSTEM APPLICATION
K131489 · IYO
Tractus Corporation
Radiology · 33d
Cleared Jun 25, 2013
DDRCRUZE (DIGITAL MOBILE DIAGNOSTIC X-RAY SYSTEM)
K131314 · MQB
Swissray Medical AG
Radiology · 49d
Cleared Jun 25, 2013
PRIMI AND SECONDI SUPPORT CATHETERS
K130850 · DQY
Thermopeutix, Inc.
Cardiovascular · 90d
Cleared Jun 21, 2013
OAK RIDGE PRODUCTS SHARP CONTAINER
K130281 · MMK
Oak Ridge Products, LLC
General Hospital · 136d
Cleared Jun 18, 2013
EVENFLO ADVANCED DOUBLE ELECTRIC BREAST PUMP
K131153 · HGX
Evenflo Feeding Incorporated
Obstetrics & Gynecology · 55d
Cleared Jun 11, 2013
NON-PYROGENIC ULTRASOUND TRANSDUCER COVER
K131528 · ITX
CIVCO Medical Instruments Co., Inc.
Radiology · 14d
Cleared Jun 05, 2013
TEMPUS PRO PATIENT MONITOR
K130773 · MWI
Remote Diagnostic Technologies , Ltd.
Cardiovascular · 77d
Cleared May 30, 2013
ULTRAVERSE RX PTA BALLOON DILATATION CATHETER
K131199 · LIT
Bard Peripheral Vascular, Inc.
Cardiovascular · 34d
Cleared May 29, 2013
ETIAM PACS COMPONENTS
K131392 · LLZ
Etiam S.A.S.U.
Radiology · 15d
Cleared May 24, 2013
TERASON USMART3200T ULTRASOUND SYSTEM
K131209 · IYN
Teratech Corp.
Radiology · 25d
Cleared May 24, 2013
RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER
K130911 · LIT
Ev3, Inc.
Cardiovascular · 52d
Cleared May 17, 2013
THE VAULT SYSTEM
K124051 · LLZ
Somersault Orthopedics, Inc.
Radiology · 137d
Cleared May 13, 2013
REMINGTON MEDICAL CENTREFIRE 22 BIOPSY INSTRUMENT
K130282 · KNW
Remington Medical, Inc.
Gastroenterology & Urology · 97d
Cleared May 07, 2013
CONI
K130624 · LLZ
Globalmed
Radiology · 60d
Cleared May 07, 2013
UNITRON TINNITUS MASKER FEATURE
K130494 · KLW
Unitron Hearing
Ear, Nose, Throat · 70d
Cleared Apr 22, 2013
STAYHEALTHY HEALTH KIOSK, STAYHEALTHY HEALTHCENTER KIOSK
K123539 · DXN
Stayhealthy, Inc.
Cardiovascular · 157d
Cleared Apr 18, 2013
SEDECAL DIGITAL RADIOGRAPHIC UPGRADE MODEL SDRU-T
K130883 · MQB
Sedecal., Sa.
Radiology · 20d