FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: General & Plastic Surgery ×
18,288 results
2569–2592 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Ethicon, Inc. Lead specialty: General & Plastic Surgery
Cleared Feb 13, 2020
Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation...
K193232 · NEY
Covidien, LLC
General & Plastic Surgery · 80d
Cleared Feb 13, 2020
ArtiSential Bipolar Fenestrated Forceps
K190909 · GEI
Livsmed, Inc.
General & Plastic Surgery · 311d
Cleared Feb 13, 2020
XenoSure Biologic Patch
K190882 · PSQ
Lemaitre Vascular
General & Plastic Surgery · 315d
Cleared Feb 11, 2020
CAPENERGY - C100, C200, C300, C400, C50
K191202 · PBX
Capenergy Medical S.L.
General & Plastic Surgery · 281d
Cleared Feb 10, 2020
Sutter Swyng non-stick bipolar forceps, single-use
K193587 · GEI
Sutter Medizintechnik GmbH
General & Plastic Surgery · 49d
Cleared Feb 07, 2020
Rochal Antimicrobial Wound Gel
K192527 · FRO
Rochal Industries, LLC
General & Plastic Surgery · 147d
Cleared Feb 06, 2020
UV Radiation Treatment System
K191571 · FTC
Xuzhou Yongkang Electronic Science...
General & Plastic Surgery · 237d
Cleared Feb 06, 2020
da Vinci Xi Surgical System, da Vinci X Surgical System
K191529 · NAY
Intuitive Surgical
General & Plastic Surgery · 241d
Cleared Feb 04, 2020
OKLand Patient Return Electrode Pad
K183148 · GEI
Auckland Medical Polymer(Tianjin)...
General & Plastic Surgery · 448d
Cleared Jan 29, 2020
Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap
K192585 · OAP
Pjm Worldwide, LLC D/B/A Phoenix...
General & Plastic Surgery · 132d
Cleared Jan 29, 2020
Biopsy Needle
K191472 · FCG
Ushare Medical, Inc.
General & Plastic Surgery · 240d
Cleared Jan 27, 2020
Xenocor Articulating Xenoscope Laparoscope
K193315 · GCJ
Xenocor, Inc.
General & Plastic Surgery · 59d
Cleared Jan 24, 2020
Cellvizio 100 Series System with Confocal Miniprobes
K191144 · OWN
Mauna Kea Technologies
General & Plastic Surgery · 269d
Cleared Jan 23, 2020
Bactisure Wound Lavage
K192349 · FQH
Next Science, LLC
General & Plastic Surgery · 147d
Cleared Jan 23, 2020
EEA Circular Stapler with Tri-Staple Technology
K192330 · GDW
Covidien
General & Plastic Surgery · 149d
Cleared Jan 21, 2020
ZELTIQ CoolSculpting System
K193566 · OOK
Zeltiq Aesthetics, Inc.
General & Plastic Surgery · 29d
Cleared Jan 17, 2020
Asimov-MKS Imaging System
K192761 · IZI
Onlume, Inc.
General & Plastic Surgery · 109d
Cleared Jan 17, 2020
PicoLazer Laser System
K192583 · GEX
Rohrer Aesthetics, LLC
General & Plastic Surgery · 120d
Cleared Jan 16, 2020
Viveve 2.0 System
K193611 · GEI
Viveve Medical, Inc.
General & Plastic Surgery · 21d
Cleared Jan 16, 2020
Stellar M22 for Intense Pulsed Light (IPL) and Laser System
K193500 · GEX
Lumenis, Ltd.
General & Plastic Surgery · 30d
Cleared Jan 15, 2020
UNO 30
K190028 · OMP
Genadyne Biotechnologies
General & Plastic Surgery · 373d
Cleared Jan 15, 2020
INTRAcel RF Microneedle System
K183284 · GEI
Jeisys Medical, Inc.
General & Plastic Surgery · 415d
Cleared Jan 14, 2020
XTRAC Momentum Excimer Laser System
K193478 · GEX
Strata Skin Sciences, Inc.
General & Plastic Surgery · 29d
Cleared Jan 13, 2020
Erchonia Emerald
K192544 · OLI
Erchonia Corporation
General & Plastic Surgery · 119d