FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: General & Plastic Surgery ×
18,256 results
49–72 of 18,256
Search insights Median review: 84d Cleared: 100% Top manufacturer: Ethicon, Inc. Lead specialty: General & Plastic Surgery
Cleared Jun 12, 2026
Barbed PDO Suture
K252171 · NEW
Sutura Medical Technology, Inc.
General & Plastic Surgery · 337d
Cleared Jun 11, 2026
FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air,...
K260710 · GCJ
FloShield, Inc.
General & Plastic Surgery · 99d
Cleared Jun 11, 2026
Dexter L6 System
K260653 · SDD
Distalmotion SA
General & Plastic Surgery · 104d
Cleared Jun 10, 2026
“Tech-Image” Video Endoscope System
K260414 · GCJ
Tech-Image CO., LTD.
General & Plastic Surgery · 121d
Cleared Jun 09, 2026
ERBECRYO 2 Cryosurgical Unit and Accessories
K261806 · GEH
Erbe Elektromedizin GmbH
General & Plastic Surgery · 8d
Cleared Jun 09, 2026
LAP-iX2N
K253165 · GEI
Sejong Medical Co., Ltd.
General & Plastic Surgery · 256d
Cleared Jun 08, 2026
Lipocosm Harmonic System
K251944 · QPB
Lipocosm, LLC
General & Plastic Surgery · 349d
Cleared Jun 05, 2026
Catalyze
K253204 · KGN
BioTissue Holdings, Inc.
General & Plastic Surgery · 252d
Cleared Jun 05, 2026
Alma TED+ System
K251684 · OAP
Alma Lasers, Inc.
General & Plastic Surgery · 368d
Cleared Jun 04, 2026
LumiGlam Laser System (SHE-LSP601-3)
K260690 · GEX
Beijing Sano Laser S&T Development...
General & Plastic Surgery · 93d
Cleared Jun 04, 2026
TroKit Laparoscope Lens Wiper
K253994 · GCJ
TroCare, LLC
General & Plastic Surgery · 174d
Cleared Jun 04, 2026
Instrument Exit Point on Touch Surgery™ Aide
K253984 · SFE
Covidien, LLC
General & Plastic Surgery · 174d
Cleared Jun 04, 2026
GT Metabolic MagDI System (MAG-01, MAG-02, DS-01)
K253102 · SAH
Gt Metabolic Solutions, Inc.
General & Plastic Surgery · 253d
Cleared Jun 03, 2026
Tissue Approximation System
K261484 · GAR
Tas Medical, Inc.
General & Plastic Surgery · 29d
Cleared Jun 03, 2026
CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)
K260715 · OHS
The Beauty Tech Group, Ltd.
General & Plastic Surgery · 90d
Cleared Jun 03, 2026
Roosin Collagen Powder
K254034 · KGN
Roosin Medical Co., Ltd.
General & Plastic Surgery · 169d
Cleared Jun 03, 2026
Roosin Collagen Dressing
K253974 · KGN
Roosin Medical Co., Ltd.
General & Plastic Surgery · 174d
Cleared Jun 02, 2026
Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St)
K253918 · GEI
F Care Systems USA, LLC
General & Plastic Surgery · 176d
Cleared Jun 02, 2026
MILAN System
K253803 · GEI
Lumenis Be, Ltd.
General & Plastic Surgery · 186d
Cleared Jun 02, 2026
Hemospray Endoscopic Hemostat (HEMO-[X])
K253302 · QAU
Wilson-Cook Medical, Inc.
General & Plastic Surgery · 246d
Cleared Jun 02, 2026
Inno-Port Disposable Bladed Trocar
K252532 · GCJ
Taiwan Surgical Corporation
General & Plastic Surgery · 294d
Cleared May 29, 2026
ENTire IRE System
K261202 · GEI
Entire Medical , Ltd.
General & Plastic Surgery · 46d
Cleared May 29, 2026
LASEmaR 1500
K260489 · GEX
Eufoton S.R.L.
General & Plastic Surgery · 105d
Cleared May 28, 2026
780 nm SPY Portable Handheld Imaging (SPY-PHI) System
K261037 · IZI
Stryker Endoscopy
General & Plastic Surgery · 59d