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
37105–37128 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 16, 2014
MOBIS II ST SPINAL IMPLANT
K141405 · MAX
Signus Medizintechnik GmbH
Orthopedic · 111d
Cleared Sep 16, 2014
GEM Flow COUPLER Device and System
K142309 · MVR
Synovis Life Technologies, Inc.
General & Plastic Surgery · 28d
Cleared Sep 15, 2014
POLYCRYL
K140039 · GAM
Aurolab
General & Plastic Surgery · 251d
Cleared Sep 15, 2014
KATALYST REVOLVER LASER PROBES, KATALYST REVOLVER ILLUMINATED LASER PROBES,...
K140362 · HQF
Katalyst Surgical, LLC
Ophthalmic · 215d
Cleared Sep 15, 2014
M-PM-DISC (PINK)
K140758 · EBI
Merz Dental GmbH
Dental · 173d
Cleared Sep 15, 2014
SOMATOM SCOPE/SOMATOM SCOPE POWER
K140912 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 159d
Cleared Sep 15, 2014
ABPM7100
K140928 · DXN
I.E.M. GmbH
Cardiovascular · 157d
Cleared Sep 15, 2014
ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER...
K141018 · JEQ
Procter & Gamble Co.
Dental · 147d
Cleared Sep 15, 2014
HARMONIC SCALLOP BLADE, GENERATOR G11
K141122 · GEI
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 138d
Cleared Sep 15, 2014
STEREOS WORKSTATION
K141137 · LLZ
Eos Imaging
Radiology · 137d
Cleared Sep 15, 2014
GLUCOSTABILIZER INSULIN DOSING CALCULATOR
K141321 · NDC
Medical Decision Network
General Hospital · 118d
Cleared Sep 15, 2014
Sirius Femoral Stem, Size 30A
K142295 · JDI
Biomet, Inc.
Orthopedic · 28d
Cleared Sep 15, 2014
Flower Upper Extremity Plating Set
K142306 · HRS
Flower Orthopedics Corporation
Orthopedic · 27d
Cleared Sep 12, 2014
INTRA. OX HANDHELD TISSUE OXIMETER
K133983 · MUD
Vioptix, Inc.
Cardiovascular · 259d
Cleared Sep 12, 2014
NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN...
K140050 · LZA
Hartalega Sdn Bhd
General Hospital · 246d
Cleared Sep 12, 2014
ARCHITECT PX EXTRACELLULAR COLLAGEN MATRIX
K140367 · KGN
Harbor Medtech, Inc.
General & Plastic Surgery · 210d
Cleared Sep 12, 2014
MERIT HEPARIN-COATED INQWIRE DIAGNOSTIC GUIDEWIRE
K140608 · DQX
Merit Medical Systems, Inc.
Cardiovascular · 186d
Cleared Sep 12, 2014
ARTIMES BALLOON DILATATION CATHETER
K141025 · LOX
Brosmed Medical
Cardiovascular · 144d
Cleared Sep 12, 2014
SILVERLON ANTIMICROBIAL WOUND CONTACT NEGATIVE PRESSURE DRESSINGS, SILVERLON...
K141033 · OMP
Argentum Medical, LLC
General & Plastic Surgery · 143d
Cleared Sep 12, 2014
PROFEMUR RENAISSANCE CLASSIC LONG NECK HIP STEMS
K141235 · LZO
Microport Orthopedics, Inc.
Orthopedic · 122d
Cleared Sep 12, 2014
WHISPERJECT AUTOINJECTOR
K141384 · KZH
Scandinavian Health Limited
General Hospital · 108d
Cleared Sep 12, 2014
ZVPLASTY
K141419 · NDN
Zavation, LLC
Orthopedic · 106d
Cleared Sep 12, 2014
ORTHODONTIC ACRYLIC (NOT FINALIZED)
K141439 · EBI
Bisco, Inc.
Dental · 102d
Cleared Sep 12, 2014
DX-D IMAGING PACKAGE
K141602 · MQB
Agfa Healthcare N.V.
Radiology · 88d