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
34969–34992 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 27, 2015
21.3 inch (54cm) Color LCD Monitor CCL210 (CL21210)
K151134 · PGY
Jvckenwood Corporation
Radiology · 28d
Cleared May 26, 2015
LUMINA 24
K140386 · GEX
Rogers Sciences, Inc.
General & Plastic Surgery · 466d
Cleared May 26, 2015
LAGIS ENDOSCOPIC INSTRUMENTS DISPOSABLE GRASPER
K141902 · GCJ
Lagis Enterprises Co, Ltd.
General & Plastic Surgery · 316d
Cleared May 26, 2015
Oral7 Moisturizing Gel, Oral7 Moisturizing Mouthwash, Oral7 Moisturizing...
K142549 · LFD
J.C.E.C. Company, Inc. (Doing...
Dental · 258d
Cleared May 26, 2015
Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]
K142870 · QEW
Penumbra, Inc.
Cardiovascular · 237d
Cleared May 26, 2015
AMT Bridle - Nasal Tube Retention System
K142971 · KNT
Applied Medical Technology, Inc.
Gastroenterology & Urology · 224d
Cleared May 26, 2015
Human Microalbumin kit for use on SPAPLUS
K143118 · DCF
The Binding Site Group , Ltd.
Chemistry · 208d
Cleared May 26, 2015
Sickbay Clinical Platform
K143304 · MWI
Medical Informatics Corp
Cardiovascular · 189d
Cleared May 26, 2015
Versatex Monofilament Mesh
K150091 · FTL
Sofradim Production
General & Plastic Surgery · 130d
Cleared May 26, 2015
Ballancer 505 System, Model 1201-AC
K150269 · IRP
Mego Afek AC , Ltd.
Physical Medicine · 111d
Cleared May 26, 2015
Centricity Universal Viewer
K150420 · LLZ
Ge Healthcare
Radiology · 97d
Cleared May 26, 2015
Acryfree Denture Base Material and Biosens Denture Base Material
K150454 · EBI
Perflex
Dental · 95d
Cleared May 26, 2015
2.4mm X 127 cm Phoenix Atherectomy Deflecting System
K151145 · MCW
Volcano Atheromed, Inc.
Cardiovascular · 27d
Cleared May 26, 2015
Biomet Microfixation RibFix Blu Thoracic Fixation System
K151173 · HWC
Biomet Microfixation
Orthopedic · 25d
Cleared May 22, 2015
CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEM
K140068 · NBW
Polymer Technology Systems, Inc.
Chemistry · 494d
Cleared May 22, 2015
Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls
K140654 · PDJ
Abbott Laboratories
Chemistry · 434d
Cleared May 22, 2015
Whisper Pump System
K142385 · OMP
Wound RX Medical, LLC
General & Plastic Surgery · 268d
Cleared May 22, 2015
Penumbra System ACE
K142458 · NRY
Penumbra, Inc.
Neurology · 262d
Cleared May 22, 2015
SPINEDESIGN Spine Surgery Planning (Software Application)
K142648 · LLZ
Medtronic Sofamor Danek USA, Inc.
Radiology · 247d
Cleared May 22, 2015
Scrambler Therapy MC-5 A Device
K142666 · GZJ
Delta International Services &...
Neurology · 246d
Cleared May 22, 2015
DualCap
K142806 · QBP
Catheter Connections, Inc.
General Hospital · 235d
Cleared May 22, 2015
APEX-DL Spine System
K143683 · NKB
Spinecraft, LLC
Orthopedic · 149d
Cleared May 22, 2015
Battalion Universal Spacer System
K143740 · MAX
Alphatec Spine, Inc.
Orthopedic · 143d
Cleared May 22, 2015
Fine Structure Analysis(fineSA)
K150069 · LLZ
Acuitas Medical , Ltd.
Radiology · 129d