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

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176,076 results
59593–59616 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 16, 2007
FOX MEDICAL DIODE LASER SYSTEM 810NM
K063104 · GEX
Howard Instruments, Inc.
General & Plastic Surgery · 279d
Cleared May 16, 2007
SOUTHERN SPINE ANTERIOR CERVICAL STABILIZATION SYSTEM, KWIK- FIX CERVICAL...
K063764 · KWQ
Southern Spine, LLC
Orthopedic · 147d
Cleared May 16, 2007
THOR VR SINGLE DIODE LASER TREATMENT PROBE, MODEL 200 MW SINGLE VR DIODE PROBE
K070024 · ILY
Thor International
Physical Medicine · 133d
Cleared May 16, 2007
SUN SCIENTIFIC LLC-LEG COMPRESSOR AND PFAB
K070457 · MHW
Sun Scientific, LLC
General & Plastic Surgery · 89d
Cleared May 16, 2007
IOS EXTERNAL FIXATOR, MODEL 2-0-0
K070724 · KTT
Intelligent Orthopaedics, Ltd.
Orthopedic · 62d
Cleared May 16, 2007
STRYKER PEEK ZIP SUTURE ANCHOR
K070758 · MBI
Stryker Endoscopy
Orthopedic · 57d
Cleared May 16, 2007
UNIVERSAL TAPER DELTA FEMORAL HEAD
K070885 · LZO
Howmedica Osteonics Corp.
Orthopedic · 47d
Cleared May 16, 2007
SMITH & NEPHEW KINSA RC SUTURE ANCHOR
K070908 · MBI
Smith & Nephew Inc., Endoscopy Division
Orthopedic · 44d
Cleared May 16, 2007
DORO NON-STICK BIPOLAR FORCEPS, MODEL 5001-XX TO 5012-XX, DORO BIPOLAR...
K070997 · GEI
Pro-Med Instruments GmbH
General & Plastic Surgery · 37d
Cleared May 16, 2007
MODIFICATION TO ACUSON X300 ULTRASOUND SYSTEM
K071036 · IYN
Siemens Medical Solutions USA, Inc.,...
Radiology · 34d
Cleared May 16, 2007
ABSORBATACK AND APPLICATOR
K071061 · GDW
Sorbx, LLC
General & Plastic Surgery · 30d
Cleared May 16, 2007
CORDIS AVIATOR PLUS PTA BALLOON DILATATION CATHETER
K071189 · LIT
Cordis Europa, N.V.
Cardiovascular · 16d
Cleared May 16, 2007
100W CERALAS D 980NM DIODE LASER
K071295 · GEX
Biolitec, Inc.
General & Plastic Surgery · 8d
Cleared May 15, 2007
STASIS - I, II AND III
K060968 · GIZ
Wortham Laboratories, Inc.
Hematology · 403d
Cleared May 15, 2007
POWER INJECTABLE IMPLANTABLE INFUSION PORT WITH SILICONE LUMEN (ATTACHABLE...
K070003 · LJT
Medcomp
General Hospital · 132d
Cleared May 15, 2007
SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-05
K070242 · OBJ
Biosense Webster, Inc.
Cardiovascular · 95d
Cleared May 15, 2007
GVC-100
K070840 · EMA
GC America, Inc.
Dental · 49d
Cleared May 15, 2007
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
K070861 · LZA
Hong Xin Rubber Products Co., Ltd.
General Hospital · 48d
Cleared May 15, 2007
LMS-LUNG/TRACK
K070868 · LLZ
Median Technologies
Radiology · 47d
Cleared May 15, 2007
RUBICOR MAGIC BREAST BIOPSY DEVICE, MODEL 31537
K071048 · KNW
Rubicor Medical, Inc.
Gastroenterology & Urology · 32d
Cleared May 14, 2007
INTERGRO ORAL
K070147 · NUN
Biomet 3i
Dental · 118d
Cleared May 14, 2007
DUPEL TRANSPORT IONTOPHORESIS SYSTEM
K070427 · EGJ
Empi
Physical Medicine · 90d
Cleared May 14, 2007
MYRIAN
K071000 · LLZ
Intrasense
Radiology · 35d
Cleared May 14, 2007
BIOGRAPH 6 TRUEPOINT, MODEL BIOGRAPH 6 - P/N 10238197
K071068 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 28d