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
54217–54240 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 26, 2009
DX6605E-TENS, DX6605E-G, DX6609-G
K082057 · GZJ
Shenzhen Dongdixin Technology Co., Ltd.
Neurology · 220d
Cleared Feb 26, 2009
COPA AMD
K082296 · FRO
Covidien Lp, Formerly Registered AS...
General & Plastic Surgery · 198d
Cleared Feb 26, 2009
ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL
K082638 · KLI
Siemens Healthcare Diagnostics, Inc.
Chemistry · 169d
Cleared Feb 26, 2009
ACRYDERM ANTIMICROBIAL SILVER GEL WOUND DRESSING MODEL #B
K083103 · FRO
Acrymed, Inc.
General & Plastic Surgery · 129d
Cleared Feb 26, 2009
BUSSE SURGICAL DRAPE
K083424 · KKX
Busse Hosipital Disposables
General Hospital · 99d
Cleared Feb 26, 2009
STRAUMANN DENTAL IMPLANT SYSTEM
K083550 · DZE
Straumann USA
Dental · 87d
Cleared Feb 26, 2009
ZIMMER UNIVERSAL LOCKING SYSTEM 2.7 MM LOCKING PLATES AND SCREWS ( TIVANIUM...
K083654 · HRS
Zimmer, Inc.
Orthopedic · 78d
Cleared Feb 26, 2009
LH-75T PHOTOTHERAPY SYSTEM
K090097 · FTC
Lerner Medical Devices, Inc.
General & Plastic Surgery · 42d
Cleared Feb 26, 2009
MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS
K090260 · DZE
Straumann Manufacturing, Inc.
Dental · 23d
Cleared Feb 26, 2009
FORA IR22 EAR THERMOMETER, MODEL TD-1262
K090294 · FLL
Taidoc Technology Corporation
General Hospital · 21d
Cleared Feb 26, 2009
SILVER ALGINATE 11 WOUND DRESSING
K090453 · FRO
Advanced Medical Solutions Limited
General & Plastic Surgery · 3d
Cleared Feb 25, 2009
NAVIGATION PROBES
K082404 · GZL
We Sense, Ltd.
Neurology · 188d
Cleared Feb 25, 2009
CONTEC POCKET FETAL DOPPLER
K082480 · KNG
Contec Medical System Co., Ltd.
Radiology · 181d
Cleared Feb 25, 2009
GRAFTYS HBS
K082498 · MQV
Graftys
Orthopedic · 180d
Cleared Feb 25, 2009
INTELLIVUE PATIENT MONITOR, INTELLIBRIDGE MODULE, MODELS MP40, MP50, MP60,...
K082583 · MHX
Philips Medizinsysteme Boeblingen...
Cardiovascular · 170d
Cleared Feb 25, 2009
VISIX IMAGING
K082623 · LLZ
Televere Systems
Radiology · 169d
Cleared Feb 25, 2009
ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES
K082836 · FMG
Icu Medical, Inc.
General Hospital · 152d
Cleared Feb 25, 2009
EL LIGHTWAVE SUCTION ABLATOR, MODEL EL-2000-S, LIGHTWAVE SUCTION ABLATOR,...
K083281 · GEI
Linvatec Corp.
General & Plastic Surgery · 110d
Cleared Feb 25, 2009
LOCATOR IMPLANT ANCHOR ATTACHMENT SYSTEM
K083324 · NHA
Zest Anchors, Inc.
Dental · 105d
Cleared Feb 25, 2009
RENASYS GO NEGATIVE PRESSURE WOUND THERAPY
K083375 · OMP
Smith & Nephew, Inc.
General & Plastic Surgery · 103d
Cleared Feb 25, 2009
PACP
K083663 · KWQ
Pioneer Surgical Technology
Orthopedic · 77d
Cleared Feb 25, 2009
ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SC
K083683 · KRH
Genesee Biomedical, Inc.
Cardiovascular · 75d
Cleared Feb 25, 2009
BONEVUE
K083691 · LLZ
Micromri, Inc.
Radiology · 75d
Cleared Feb 25, 2009
TAD AND TAD II TAPERED GUIDE WIRES
K083732 · DQX
Abbott Vascular
Cardiovascular · 71d