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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: General & Plastic Surgery ×
18,368 results
2329–2352 of 18,368
Search insights Median review: 84d Cleared: 100% Top manufacturer: Intuitive Surgical, Inc. Lead specialty: General & Plastic Surgery
Cleared Feb 18, 2021
Demetra Analytics Toolkit
K201408 · PSN
Barco N.V.
General & Plastic Surgery · 266d
Cleared Feb 10, 2021
da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X...
K203632 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 61d
Cleared Feb 10, 2021
FORE-SIGHT ELITE Absolute Tissue Oximeter
K203490 · MUD
Edwards Lifesciences, LLC
General & Plastic Surgery · 75d
Cleared Feb 05, 2021
Antibacterial Bandage
K201324 · FRO
Jiangsu Excellence Medical Supplies...
General & Plastic Surgery · 263d
Cleared Feb 05, 2021
Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal...
K200320 · GDW
M/s. Meril Endo Surgery Private Limited.
General & Plastic Surgery · 364d
Cleared Feb 02, 2021
CellFX System
K203299 · GEI
Pulse Biosciences, Inc.
General & Plastic Surgery · 85d
Cleared Feb 01, 2021
Monopolar Hook
K203603 · GCJ
Human Xtensions , Ltd.
General & Plastic Surgery · 54d
Cleared Feb 01, 2021
FAST-FIX FLEX
K203393 · GAT
Smith & Nephew, Inc.
General & Plastic Surgery · 75d
Cleared Jan 29, 2021
Rapid Acoustic Pulse Device
K201801 · GEX
Soliton, Inc.
General & Plastic Surgery · 213d
Cleared Jan 29, 2021
DEX Device
K191878 · GEI
Dex Surgical
General & Plastic Surgery · 564d
Cleared Jan 29, 2021
EndoClot
K190677 · QAU
Endoclot Plus Co., Ltd.
General & Plastic Surgery · 686d
Cleared Jan 28, 2021
LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial...
K201016 · FRO
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 286d
Cleared Jan 26, 2021
BTL-899ST
K202199 · GEI
Btl
General & Plastic Surgery · 174d
Cleared Jan 22, 2021
VirtueRF
K202415 · GEI
ShenB Co., Ltd.
General & Plastic Surgery · 151d
Cleared Jan 22, 2021
ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue...
K201696 · GEI
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 214d
Cleared Jan 22, 2021
ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue...
K201066 · GEI
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 275d
Cleared Jan 22, 2021
MIIN
K193266 · GEX
Medico USA, Inc.
General & Plastic Surgery · 423d
Cleared Jan 21, 2021
EEA Circular Stapler with Tri-Staple Technology
K202507 · GDW
Covidien
General & Plastic Surgery · 143d
Cleared Jan 21, 2021
Forwarts
K201366 · GEH
Pronova Laboratories BV
General & Plastic Surgery · 244d
Cleared Jan 19, 2021
HBP7 Settable Hemostatic Bone Putty
K202363 · MTJ
Orthocon, Inc.
General & Plastic Surgery · 153d
Cleared Jan 19, 2021
Potenza
K201685 · GEI
Jeisys Medical, Inc.
General & Plastic Surgery · 211d
Cleared Jan 17, 2021
Nanum Syringe
K201930 · FMF
Nanum Company Co., Ltd.
General & Plastic Surgery · 191d
Cleared Jan 14, 2021
OmniGuide BeamPath OTO-U Fiber
K203241 · GEX
Omniguide, Inc.
General & Plastic Surgery · 72d
Cleared Jan 11, 2021
Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)-...
K203397 · KNW
Biopsybell S.R.L.
General & Plastic Surgery · 54d