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
60529–60552 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 26, 2007
CARRARA VOLUMIA
K070019 · EIH
Dentsply Intl.
Dental · 23d
Cleared Jan 26, 2007
POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE
K070040 · LYZ
Super Safe Plastic Products Co., Ltd.
General Hospital · 23d
Cleared Jan 26, 2007
FLIGHT DENTAL SYSTEMS A-SERIES DENTAL OPERATIVE UNIT
K070196 · EIA
Hr Dental Products, Inc.
Dental · 4d
Cleared Jan 25, 2007
IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107, 2L3107K
K052973 · FRN
Baxter Healthcare Corp
General Hospital · 458d
Cleared Jan 25, 2007
DERMATHERAPY, MODEL 22216
K061242 · FMW
Precision Fabrics Group, Inc.
General Hospital · 267d
Cleared Jan 25, 2007
MEPILEX AG ABSORBENT SILICONE-COATED DRESSING
K061554 · FRO
Molnlycke Health Care
General & Plastic Surgery · 234d
Cleared Jan 25, 2007
ACTIM PROM AND CONTROLS
K061886 · OAM
Medix Biochemica
Chemistry · 206d
Cleared Jan 25, 2007
CONMED ABC DISSECTING BLADE ELECTRODE, MODEL 139330
K062082 · GEI
Conmed Corporation
General & Plastic Surgery · 188d
Cleared Jan 25, 2007
PHASE 3, MODEL DT-1
K062099 · DRL
Datrend Systems, Inc.
Cardiovascular · 185d
Cleared Jan 25, 2007
SENTINEL
K062397 · DXH
Del Mar Reynolds Medical, Ltd.
Cardiovascular · 162d
Cleared Jan 25, 2007
VUSION TS, PS, AND CS PARTIAL VERTEBRAL BODY REPLACEMENTS
K062666 · MQP
Ortho Development Corp.
Orthopedic · 140d
Cleared Jan 25, 2007
MICROTEK MEDICAL SURGICAL GOWN/TOGA
K062899 · FYA
Microtek Medical, Inc.
General Hospital · 120d
Cleared Jan 25, 2007
POWERPORT POLYMETRIC PORT WITH 8 FR S/L CHRONOFLEX CATHETER
K063377 · LJT
C.R. Bard, Inc.
General Hospital · 78d
Cleared Jan 25, 2007
PORTEX HYPODERMIC NEEDLE- PRO EDGE SAFETY DEVICE, 18GX1, 401810, 19GX1,...
K063450 · FMI
Smiths Medical Asd, Inc.
General Hospital · 71d
Cleared Jan 25, 2007
FEMORAL INTRAFIX SCREW AND SHEATH
K063577 · MBI
Johnson & Johnson Company
Orthopedic · 56d
Cleared Jan 25, 2007
MOORFLPI FULL-FIELD LASER PERFUSION IMAGER
K063586 · DPT
Moor Instruments, Ltd.
Cardiovascular · 55d
Cleared Jan 25, 2007
V.A.C. FREEDOM CANISTER, MODEL M6275421
K063590 · OMP
Kci USA, Inc.
General & Plastic Surgery · 55d
Cleared Jan 25, 2007
PILOT SPINAL SYSTEM
K063601 · MNI
Life Spine
Orthopedic · 52d
Cleared Jan 25, 2007
GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091
K063664 · LSL
Gen-Probe, Inc.
Microbiology · 48d
Cleared Jan 25, 2007
SHARPS CONTAINER, MODEL 039-413
K063666 · MMK
Biodex Medical Systems, Inc.
General Hospital · 45d
Cleared Jan 25, 2007
GEODESIC EEG SYSTEM 300
K063797 · OLT
Electrical Geodesics, Incorporated
Neurology · 34d
Cleared Jan 25, 2007
MODIFICATION TO HIPSTAR FEMORAL STEM
K063822 · LPH
Stryker Orthopaedics
Orthopedic · 30d
Cleared Jan 25, 2007
DIOMED DELTA 25
K063828 · GEX
Diomed, Ltd.
General & Plastic Surgery · 30d
Cleared Jan 25, 2007
REVLITE C6 Q-SWITCHED ND:YAG LASER SYSTEM
K063834 · GEX
Hoya Conbio, Inc.
General & Plastic Surgery · 30d