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"
865–888 of 1,198
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 30, 2009
RECRUIT MICROCATHETER
K091563 · MMX
Reverse Medical Corporation
Cardiovascular · 63d
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 28, 2009
ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEM
K092159 · IYN
Medison Co., Ltd.
Radiology · 12d
Cleared Jul 24, 2009
JUMAO OXYGEN CONCENTRATOR, MODEL JM-07000HI, JM-07000I, JM-07000
K090007 · CAW
Danyang Jumao Healthcare Equipment...
Anesthesiology · 203d
Cleared Jul 20, 2009
PROGENY VANTAGE PANORAMIC X-RAY SYSTEM
K091866 · MUH
Midmark
Radiology · 26d
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 25, 2009
ENDOVIVE LOW PROFILE REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX, 8283, 8284, 8285
K083685 · KNT
Mri Manufacturing and Research, Inc.
Gastroenterology & Urology · 195d
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 18, 2009
MUCHECK V8
K091602 · IYE
Oncology Data Systems, Inc.
Radiology · 15d
Cleared Jun 17, 2009
FLEXICARE MEDICAL ENDOTRACHEAL TUBES
K091591 · BTR
Flexicare Medical, Ltd.
Anesthesiology · 15d
Cleared Jun 17, 2009
STRATAPULSE TS AND STRATAPULSE
K090837 · ONF
Advanced Medical Photonics
General & Plastic Surgery · 82d
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 26, 2009
GE LOGIQ I/E & VIVID E COMPACT ULTRASOUND
K091374 · IYO
Ge Medical Systems China Co., Ltd.
Radiology · 15d
Cleared May 22, 2009
SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A,...
K091417 · OCY
Terumo Corp.
Gastroenterology & Urology · 9d
Cleared May 21, 2009
PRIMUS STEAM STERILIZER, MODELS PSS5-G-1 AND PSS5-M
K082817 · FLE
Primus Sterilizer Company, LLC
General Hospital · 238d
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 May 08, 2009
NEUROPET
K091269 · KPS
Photodetection Systems, Inc.
Radiology · 8d
Cleared May 05, 2009
GE VENUE 40, MODEL 5324338
K091164 · IYN
Ge Medical Systems China Co., Ltd.
Radiology · 13d