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
41857–41880 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 07, 2013
GENESIS HEALTH RECORD SYSTEM, (GHRS)
K123136 · NBW
Genesis Health Technologies
Chemistry · 153d
Cleared Mar 07, 2013
K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET (PAIS)
K123344 · FPA
Kawasumi Laboratories, Inc.
General Hospital · 127d
Cleared Mar 07, 2013
ECLIPSE SOFT TISSUE FASTENER
K123350 · MBI
MedShape, Inc.
Orthopedic · 127d
Cleared Mar 07, 2013
NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS
K123395 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 122d
Cleared Mar 07, 2013
LITTLE ANGELS SWADDLING BLANKET
K123411 · PDH
Bionix Development Corp.
General Hospital · 122d
Cleared CT Mar 07, 2013
SHUNTCHECK
K123554 · JXG
Neurodx Development, LLC
Neurology · 108d
Cleared Mar 07, 2013
DIMENSION VISTA
K123677 · JIF
Siemens Healthcare Diagnostics
Chemistry · 97d
Cleared Mar 07, 2013
SAM JUNCTIONAL TOURNIQUET
K123694 · DXC
Sam Medical Products
Cardiovascular · 94d
Cleared Mar 07, 2013
SILVERSPEED HYDROPHILIC GUIDEWIRE, X-CELERATOR HYDROPHILIC EXCHANGE...
K124007 · DQX
Micro Therapeutics, Inc. D/B/A: Ev3,...
Cardiovascular · 71d
Cleared Mar 07, 2013
HERO GRAFT
K124039 · DSY
Hemoshpere, Inc., A Cryolife Company
Cardiovascular · 69d
Cleared Mar 07, 2013
EVRF SYSTEM
K130283 · ONQ
F Care Systems NV
General & Plastic Surgery · 30d
Cleared Mar 06, 2013
INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE
K120815 · FPD
Philips Medical Systems
Gastroenterology & Urology · 352d
Cleared Mar 06, 2013
CLEARED UNDER GRAFTON II EDBM
K122513 · MBP
Medtronic Sofamor Danek, Inc.
Orthopedic · 201d
Cleared Mar 06, 2013
KANGAROO NASAL MASK
K122847 · BZD
Respironics, Inc.
Anesthesiology · 169d
Cleared Mar 06, 2013
NAUTILUS SPINAL SYSTEM
K123373 · NKB
Life Spine
Orthopedic · 125d
Cleared Mar 05, 2013
ULTRASONIC SCALER
K113717 · ELC
Nakanishi, Inc.
Dental · 442d
Cleared Mar 05, 2013
COLS® FIXATION SYSTEM
K120740 · MBI
Fournitures Hospitalieres Industrie
Orthopedic · 358d
Cleared Mar 05, 2013
JMS SAFE WING CATH (SWC)
K121488 · FOZ
JMS North America Corporation
General Hospital · 291d
Cleared Mar 05, 2013
DENTOCORE / DENTOCORE BODY
K121769 · EBF
Itena Clinical
Dental · 263d
Cleared Mar 05, 2013
VIDAS LYME IGG
K122986 · LSR
Biomerieux S.A.
Microbiology · 160d
Cleared Mar 05, 2013
FORTIVA PORCINE DERMIS
K123356 · FTM
Rti Biologics, Inc.
General & Plastic Surgery · 125d
Cleared Mar 05, 2013
BIOMONDE LARVAE
K123449 · NQK
Biomonde (A Trading Name of Zoobiotic...
General & Plastic Surgery · 116d
Cleared Mar 05, 2013
CALLISTO EYE
K123464 · NFJ
Carl Zeiss Meditec, AG
Ophthalmic · 116d
Cleared Mar 05, 2013
CIMVA UNIVERSAL
K123472 · MHX
Therapeutic Monitoring Systems (Tms),...
Cardiovascular · 112d