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
37201–37224 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 04, 2014
BIOMET GRAFT DELIVERY SYRINGES
K140710 · FMF
Biomet Spine (Aka Ebi, LLC)
General Hospital · 167d
Cleared Sep 04, 2014
COMPAT ENTERAL DELIVERY PUMP SETS
K140947 · PIF
Nestle Healthcare Nutrition, Inc.
Gastroenterology & Urology · 143d
Cleared Sep 04, 2014
CALCULASE II
K140964 · GEX
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 142d
Cleared Sep 04, 2014
FLOSHIELD 10MM ENDOSCOPIC CANNULA AND BLUNT OBTURATOR, FLOSHIELD 10MM...
K141272 · GCJ
Minimmally Invasive Devices
General & Plastic Surgery · 112d
Cleared Sep 04, 2014
IVAS 8 GAUGE BONE BIOPSY KIT
K141673 · KNW
Stryker Corporation
Gastroenterology & Urology · 73d
Cleared Sep 04, 2014
BIOGEL PL MICRO SURGICAL GLOVE
K141719 · KGO
Molnlycke Health Care Us, LLC
General Hospital · 71d
Cleared Sep 04, 2014
HYDRAVIEW GUIDEWIRE
K141831 · DQX
Brivant Limited
Cardiovascular · 59d
Cleared Sep 04, 2014
HFD100 ROCKER ARM ACCESSORY
K141950 · HBL
Imris, Inc.
Neurology · 48d
Cleared Sep 03, 2014
ALERE PBP2A SA/CONS CULTURE COLONY TEST
K133851 · MYI
Alere Scarborough, Inc.
Microbiology · 258d
Cleared Sep 03, 2014
GENESYS SPINE ANTERIOR BUTTRESS PLATE SYSTEM
K133911 · KWQ
Genesys Spine
Orthopedic · 254d
Cleared Sep 03, 2014
GENERAL SPINAL SYSTEM
K134011 · MNH
Changzhou Dean Medical Instrument Co,...
Orthopedic · 247d
Cleared Sep 03, 2014
POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE
K140418 · LZA
Wrp Rubber Products Sdn Bhd
General Hospital · 197d
Cleared Sep 03, 2014
XENCO MEDICAL CERVICAL INTERBODY SYSTEM
K140786 · ODP
Xenco Medical, LLC
Orthopedic · 156d
Cleared CT Sep 03, 2014
VDRIVE WITH V-LOOP/ VDRIVE DUO
K140804 · DXX
Stereotaxis, Inc.
Cardiovascular · 156d
Cleared Sep 03, 2014
INFRARED HEATING DEVICE
K140865 · ILY
Pro Medical Supplies, Inc.
Physical Medicine · 153d
Cleared Sep 03, 2014
VERICORE ZIRCONIA BLANKS
K140877 · EIH
Whip-Mix Corp.
Dental · 149d
Cleared CT Sep 03, 2014
STA LIATEST D-DI
K141144 · DAP
Diagnostica-Stago
Hematology · 124d
Cleared Sep 03, 2014
PHOT-X IIS MODEL 505
K141293 · EHD
Takara Belmont Corporation
Radiology · 107d
Cleared Sep 03, 2014
VOLUMETRIC INCENTIVE SPIROMETER
K141355 · BWF
Besmed Health Business Corporation
Anesthesiology · 103d
Cleared Sep 03, 2014
TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
K141495 · DXO
Edwards Lifesciences, LLC
Cardiovascular · 89d
Cleared Sep 03, 2014
SYNAPSE 3D TENSOR ANALYSIS
K141514 · LLZ
Fujifilm Meidcal Systems U.S.A.,Inc.
Radiology · 86d
Cleared Sep 03, 2014
VITALOGRAPH MODEL 7000 SPIROTRAC
K141546 · BZG
Vitalograph (Ireland) , Ltd.
Anesthesiology · 85d
Cleared Sep 03, 2014
EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE POWDER FREE
K141590 · LZA
Eco Medi Glove Sdn. Bhd.
General Hospital · 82d
Cleared Sep 03, 2014
ARTHREX IBALANCE TKA SYSTEM
K141635 · MBH
Arthrex, Inc.
Orthopedic · 76d