Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
55801–55824 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 25, 2008
DEVILBISS PORTABLE OXYGEN CONCENTRATOR, 306 SERIES
K081468 · CAW
Sunrise Medical
Anesthesiology · 90d
Cleared Aug 25, 2008
PIONEER SURGICAL TECHNOLOGY NANOSS BVF-E, MODELS 5, 10, 20CC
K081558 · MQV
Pioneer Surgical Technology
Orthopedic · 83d
Cleared Aug 25, 2008
MODIFICATION TO HI-ART TREATMENT SYSTEM
K082005 · MUJ
Tomotherapy Incorporated
Radiology · 42d
Cleared Aug 25, 2008
SONOSITE MAXX SERIES ULTRASOUND SYSTEM
K082098 · IYN
Sonosite,Inc.
Radiology · 31d
Cleared Aug 25, 2008
MICRO GUIDE CATHETER XP
K082143 · PDU
Cordis Corp.
Cardiovascular · 26d
Cleared Aug 25, 2008
CENTRICITY PACS IW
K082318 · LLZ
Ge Healthcare Dynamic Imaging Solutions
Radiology · 12d
Cleared Aug 22, 2008
CYGNUS 12 LEAD ECG MODULE
K072950 · KRE
Cygnus, LLC
Cardiovascular · 309d
Cleared Aug 22, 2008
OHMNISCAN NG
K073334 · MNW
Christine Valmy, Inc.
Gastroenterology & Urology · 268d
Cleared Aug 22, 2008
ELECSYS ANTI-TSHR CALCHECK
K080643 · JJX
Roche Diagnostics
Chemistry · 169d
Cleared Aug 22, 2008
PINNACLE PELVIC FLOOR REPAIR KIT II
K081048 · OTP
Boston Scientific Corp
Obstetrics & Gynecology · 130d
Cleared Aug 22, 2008
PAINSHIELD MD
K081075 · PFW
Nano Vibronix , Ltd.
Physical Medicine · 128d
Cleared Aug 22, 2008
STERIS RESERT XL TEST STRIP
K081600 · JOJ
STERIS Corporation
General Hospital · 77d
Cleared Aug 22, 2008
YSIO
K081722 · KPR
Siemens Medical Solutions USA, Inc.
Radiology · 65d
Cleared Aug 22, 2008
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE 1.00
K081983 · MHX
Philips Medical Systems
Cardiovascular · 42d
Cleared Aug 22, 2008
HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS
K082009 · CAF
Hsiner Co., Ltd.
Anesthesiology · 30d
Cleared Aug 22, 2008
DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440
K082030 · DLJ
Siemens Healthcare Diagnostics, Inc.
Toxicology · 36d
Cleared Aug 22, 2008
RADVISION ET DIAGNOSTIC X-RAY SYSTEM
K082064 · KPR
Almana Medical Imaging
Radiology · 32d
Cleared Aug 22, 2008
MSC LIPID CONTROL
K082067 · JJY
Maine Standards Co.
Chemistry · 31d
Cleared Aug 22, 2008
RHYTEC, INC., PORTRAIT PSR
K082197 · GEI
Rhytec Incorporated
General & Plastic Surgery · 18d
Cleared Aug 22, 2008
WESTAR SERIES DENTAL UNITS
K082294 · EIA
Westar Medical Products, Inc.
Dental · 10d
Cleared Aug 21, 2008
GLUCOCARE INTENSIVE GLYCEMIC CONTROL SYSTEM
K081388 · NDC
Pronia Medical System, LLC
General Hospital · 94d
Cleared Aug 21, 2008
ORTHODONTIC TEMPORARY ANCHORAGE IMPLANT SCREW
K081393 · OAT
G & H Wire Co.
Dental · 94d
Cleared Aug 21, 2008
XERACEM
K081405 · EMA
Doxa Dental AB
Dental · 94d
Cleared Aug 21, 2008
SMITH & NEPHEW OXINIUM DH FEMORAL HEADS
K081566 · LPH
Smith & Nephew, Inc.
Orthopedic · 78d