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
65305–65328 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 28, 2005
POCKET TRANSCRANIAL AND VASCULAR DOPPLER SPECTRUM ANALYZER, MODEL 500P
K051739 · IYN
Multigon Industries, Inc.
Radiology · 30d
Cleared Jul 28, 2005
MODEL 3873 1* 8 AND MODEL 3874 1* 8 COMPACT TEST STIMULATION LEADS
K051773 · GZB
Medtronic Inc.,Neurological Division.
Neurology · 27d
Cleared Jul 28, 2005
JETLITE 5000
K051780 · EBZ
J. Morita USA, Inc.
Dental · 27d
Cleared Jul 27, 2005
MS 9/5 HEMATOLOGY ANALYZER
K050436 · GKZ
Melet Schloesing Laboratories USA
Hematology · 155d
Cleared Jul 27, 2005
XIA 4.5 SPINAL SYSTEM
K050461 · MNH
Stryker Spine
Orthopedic · 154d
Cleared Jul 27, 2005
CLEVER TD-1107 EAR/SKIN/SURFACE IR THERMOMETER, CLEVER TD-1110...
K050463 · FLL
Taidoc Technology Corporation
General Hospital · 154d
Cleared Jul 27, 2005
MEDTRONIC ORTHOPAEDIC TRAUMA APPLICATION
K050651 · HAW
Medtronic Navigation, Inc.
Neurology · 135d
Cleared Jul 27, 2005
OMNITECH SYSTEM & EASY LOCK OSTEOSYSTEM WITH XTREMITIES PLATES
K050681 · HRS
TriMed, Inc.
Orthopedic · 133d
Cleared Jul 27, 2005
S4 SPINAL SYSTEM
K050979 · MNI
Aesculap, Inc.
Orthopedic · 99d
Cleared Jul 27, 2005
DISPOSABLE POWDER FREE VINYL EXAM GLOVE YELLOW COLOR
K051393 · LYZ
Ever Global Enterprise Corporation
General Hospital · 61d
Cleared Jul 27, 2005
ALEUTIAN SPACER SYSTEM
K051454 · MQP
K2m, LLC
Orthopedic · 55d
Cleared Jul 27, 2005
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS - RIFAMPIN
K051478 · LON
Dade Behring, Inc.
Microbiology · 54d
Cleared Jul 27, 2005
MEDICINELODGE ZIPKNOT
K051488 · NVH
Medicinelodge, Inc.
General & Plastic Surgery · 51d
Cleared Jul 27, 2005
MIELO-CAN, BEST-LISAS, BEN - BONE BIOPSY. FAST-CUT, COLT, SPRING-CUT,...
K051506 · FCG
Sterylab S.R.L.
Gastroenterology & Urology · 50d
Cleared Jul 27, 2005
ERBE ERBOKRYO CA CRYOSURGICAL UNIT & ACCESSORIES
K051509 · GEH
Erbe USA, Inc.
General & Plastic Surgery · 50d
Cleared Jul 27, 2005
TRABECULAR METAL REVISION SHELL LINERS
K051516 · JDI
Zimmer, Inc.
Orthopedic · 49d
Cleared Jul 27, 2005
SANARUS CASSI II ROTATIONAL CORE BIOPSY SYSTEM, MODEL CS2000
K051581 · KNW
Sanarus Medical, Inc.
Gastroenterology & Urology · 42d
Cleared Jul 27, 2005
SYNTHES (USA) DISTRACTION OSTEOGENESIS SYSTEM
K051600 · KTT
Synthes (Usa)
Orthopedic · 41d
Cleared Jul 27, 2005
EXCALIBUR IV LIGHT THERAPY SYSTEM, MODEL SGEX4-001
K051631 · NHN
Stargate International, Inc.
Physical Medicine · 37d
Cleared Jul 27, 2005
DERMILLUME RED, MODEL HR1000
K051681 · ILY
Care Electronics, Inc.
Physical Medicine · 34d
Cleared Jul 27, 2005
MODIFICATION TO:TRABECULAR METAL FEMORAL CONE AUGMENTS, MODELS 03-125-ZZZZ
K051756 · JWH
Zimmer Trabecular
Orthopedic · 28d
Cleared Jul 27, 2005
THE BIOPLATE RESORBABLE ENDOBROW FIXATION SYSTEM
K051845 · JEY
Bioplate, Inc.
Dental · 20d
Cleared Jul 27, 2005
GRANDIO
K051867 · EBF
Voco GmbH
Dental · 16d
Cleared Jul 27, 2005
GRANDIO FLOW
K051868 · EBF
Voco GmbH
Dental · 16d