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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
50689–50712 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 12, 2010
FIBERLASE C02 LASER WAVEGUIDE
K100384 · GEX
Lumenis, Ltd.
General & Plastic Surgery · 55d
Cleared Apr 12, 2010
MODIFICATION TO: TRIO+SPINAL FIXATION SYSTEM
K100737 · NKB
Stryker Spine
Orthopedic · 28d
Cleared Apr 12, 2010
RENEGADE HI-FLO FATHOM KIT MODEL M001182XXX
K100892 · KRA
Boston Scientific Corp
Cardiovascular · 12d
Cleared Apr 09, 2010
SKLARLITE RIGID STERILIZATION CONTAINER SYSTEM
K091720 · KCT
Sklar Corp.
General Hospital · 302d
Cleared Apr 09, 2010
PEAK EXPIRATORY FLOW METER, KN-9710
K092335 · BZH
K-Jump Health Co., Ltd.
Anesthesiology · 248d
Cleared Apr 09, 2010
ULTRAVIEW DM3 MONITOR
K093802 · DXN
Zoe Medical, Inc.
Cardiovascular · 119d
Cleared Apr 09, 2010
ETHICON PHYSIOMESH, FLEXIBLE COMPOSITE MESH
K093932 · FTL
Ethicon GmbH
General & Plastic Surgery · 108d
Cleared Apr 09, 2010
MASTER-VU A-SCAN, MV4500
K100252 · IYO
Sonomed, Inc.
Radiology · 71d
Cleared Apr 09, 2010
T-FORM EXTREMITY IMMOBILIZER, MODEL RT-6060
K100264 · IYE
Bionix Development Corp.
Radiology · 71d
Cleared Apr 09, 2010
LIQUIBAND ULTIMA, LUT 003
K100284 · MPN
Medlogic Global Limited
General & Plastic Surgery · 67d
Cleared Apr 09, 2010
NEUROLINK IP MODEL: PK1117
K100683 · GWQ
Natus Medical Incorporated
Neurology · 30d
Cleared Apr 08, 2010
POWDER-FREE VINYL EXAM GLOVES
K091772 · LYZ
Shijiazhuang Huijingyuan Plastic Co,...
General Hospital · 296d
Cleared Apr 08, 2010
POLY FIT HIGH HYDRATING ANTIMICROBIAL DRESSINGS
K092348 · FRO
Polyremedy, Inc.
General & Plastic Surgery · 247d
Cleared Apr 08, 2010
POLY FIT + ABSORBING AND HIGH ABSORBING ANTIMICROBIAL DRESSINGS
K092351 · FRO
Polyremedy, Inc.
General & Plastic Surgery · 247d
Cleared Apr 08, 2010
CATHETER CONNECTIONS DUALCAP
K093229 · QBP
Catheter Connections, Inc.
General Hospital · 176d
Cleared Apr 08, 2010
CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION
K093288 · QYX
Cardionet, Inc.
Cardiovascular · 170d
Cleared Apr 08, 2010
BC-3200 AUTO HEMATOLOGY ANALYZER,M-30D DILUENT, M-30R RINSE, M-30CFL LYSE,...
K093394 · GKZ
Shenzhen Mindray Bio-Medical...
Hematology · 160d
Cleared Apr 08, 2010
DIAZYME CYSTATIN C ASSAY
K093680 · NDY
Diazyme Laboratories
Chemistry · 132d
Cleared Apr 08, 2010
MYKNEE CUTTING BLOCKS
K093806 · JWH
Medacta International S.A.
Orthopedic · 118d
Cleared Apr 08, 2010
UNICEM
K094007 · EMA
3M Espe AG Dental Products
Dental · 101d
Cleared Apr 08, 2010
M SEIRES PATIENT MONITOR MODEL M66, M69, M8000, M9000, M7000
K100046 · MHX
Guangdong Biolight Meditech Co., Ltd.
Cardiovascular · 90d
Cleared Apr 08, 2010
XCERAM
K100250 · EIH
Xceramusa
Dental · 71d
Cleared Apr 08, 2010
ORS VISUAL
K100335 · LLZ
Object Research Systems, Inc.
Radiology · 62d
Cleared Apr 08, 2010
XKNIFE 5
K100417 · MUJ
Integra Radionics, Inc.
Radiology · 51d