FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

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

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175,820 results
23593–23616 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 06, 2019
VISULAS green
K181682 · HQF
Carl Zeiss Meditec, AG
Ophthalmic · 253d
Cleared CT Mar 06, 2019
Solitaire 2 Revascularization Device, Solitaire Platinum Revascularization...
K181807 · POL
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 243d
Cleared Mar 06, 2019
Visualase Thermal Therapy System
K181859 · LLZ
Medtronic Navigation, Inc.
Neurology · 237d
Cleared Mar 06, 2019
Joule System
K182173 · GEX
Sciton, Inc
General & Plastic Surgery · 208d
Cleared Mar 06, 2019
PLANET Onco Dose
K182966 · LLZ
Dosisoft
Radiology · 131d
Cleared Mar 06, 2019
Hearing Healthcare Pro
K183201 · ETY
Db Diagnostic Systems, Inc.
Ear, Nose, Throat · 107d
Cleared Mar 06, 2019
ClearGrasp Snare
K183289 · FDI
Finemedix Co., Ltd.
Gastroenterology & Urology · 100d
Cleared CT Mar 06, 2019
GenePOC Strep A
K183366 · PGX
Genepoc, Inc.
Microbiology · 92d
Cleared Mar 06, 2019
ChoiceSpine Stealth Cervical Spacer System
K183397 · ODP
Choicespine, LP
Orthopedic · 89d
Cleared Mar 05, 2019
MAC Medical D-Series Blanket and Solution Warming Cabinets
K180842 · LGZ
Mac Medical, Inc.
General Hospital · 340d
Cleared Mar 05, 2019
ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/color)
K181656 · LPL
Eyemed Technologies S.R.L.
Ophthalmic · 256d
Cleared Mar 05, 2019
Imagio Ultrasound Imaging System
K182628 · IYN
Seno Medical Instruments, Inc.
Radiology · 162d
Cleared Mar 05, 2019
Olympus Small Intestinal Capsule Endoscope System
K183053 · NEZ
Olympus Medical Systems Corp.
Gastroenterology & Urology · 123d
Cleared Mar 05, 2019
Stryker SternalPlate System
K183172 · HRS
Stryker
Orthopedic · 109d
Cleared Mar 05, 2019
Embrella Endoscopic Distal Attachment
K190030 · FED
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 57d
Cleared Mar 04, 2019
Medline Reinforced Epidural Catheter
K181782 · BSO
Medline Industries, Inc.
Anesthesiology · 244d
Cleared Mar 04, 2019
MLP Special Locking Bone Plate System
K181843 · HRS
Maxxion Medical, LLC / Baumer SA
Orthopedic · 236d
Cleared Mar 04, 2019
Dimension Vista High-Sensitivity Troponin I (TNIH) Assay
K182225 · MMI
Siemens Healthcare Diagnostics, Inc.
Chemistry · 200d
Cleared Mar 04, 2019
JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant,...
K183384 · NUC
United Consortium
Obstetrics & Gynecology · 88d
Cleared Mar 04, 2019
VS3-IR
K183453 · OWN
Medtronic
General & Plastic Surgery · 81d
Cleared Mar 04, 2019
SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices
K190193 · MAX
Spineex, Inc.
Orthopedic · 28d
Cleared Mar 04, 2019
SCARLET® AC-T Secured Anterior Cervical Cage
K190322 · ODP
Spineart
Orthopedic · 19d
Cleared Mar 03, 2019
Electronic Blood Pressure Monitor
K182495 · DXN
Shenzhen Jumper Medical Equipment...
Cardiovascular · 173d
Cleared Mar 01, 2019
XactTrace Single Use Respiratory Effort Belt System
K173793 · MNR
Embla Systems
Anesthesiology · 442d