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
1153–1176 of 18,256
Search insights Median review: 84d Cleared: 100% Top manufacturer: Intuitive Surgical, Inc. Lead specialty: General & Plastic Surgery
Cleared Dec 01, 2023
Comatryx OTC
K232758 · KGN
Strukmyer Medical, LLC
General & Plastic Surgery · 84d
Cleared Dec 01, 2023
Intense pulsed light therapy device
K232708 · ONF
Hebei Zhemai Technology Co., Ltd.
General & Plastic Surgery · 87d
Cleared Dec 01, 2023
Antibacterial Gel Wound Dressing
K231057 · FRO
Winner Medical Co., Ltd.
General & Plastic Surgery · 232d
Cleared Dec 01, 2023
LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic Probes
K230621 · GEI
Surgical Principals, Inc.
General & Plastic Surgery · 270d
Cleared Nov 30, 2023
Q-Switched Nd:Yag laser
K232716 · GEX
Hebei Zhemai Technology Co., Ltd.
General & Plastic Surgery · 86d
Cleared Nov 30, 2023
Diode laser therapy device
K232709 · GEX
Hebei Zhemai Technology Co., Ltd.
General & Plastic Surgery · 86d
Cleared Nov 29, 2023
HYBRIDknife® flex
K232033 · GEI
Erbe Elektromedizin GmbH
General & Plastic Surgery · 145d
Cleared Nov 28, 2023
Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)
K232117 · GEX
Wuhan Lotuxs Technology Co., Ltd.
General & Plastic Surgery · 134d
Cleared Nov 27, 2023
CryoThin™ Surgical System and Accessories
K231661 · GEH
Medinux (Tianjin) Technologies Co., Ltd.
General & Plastic Surgery · 173d
Cleared Nov 24, 2023
HyperSuture
K230311 · GAT
Threadstone, LLC
General & Plastic Surgery · 294d
Cleared Nov 22, 2023
IceSeed 1.5 CX 90º Needle (H7493967433170)
K232635 · GEH
Boston Scientific
General & Plastic Surgery · 84d
Cleared Nov 22, 2023
FITme Customized Silicone Implant
K232593 · FWP
Keosan Trading Co.
General & Plastic Surgery · 89d
Cleared Nov 22, 2023
Medifun Lancing Device, Model No. LD-E1
K231797 · QRL
Medifun Corporation
General & Plastic Surgery · 155d
Cleared Nov 21, 2023
KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit
K233333 · OWN
Karl Storz SE & CO. KG
General & Plastic Surgery · 53d
Cleared Nov 21, 2023
Biophotas Celluma CONTOUR
K232977 · OLI
Biophotas, Inc.
General & Plastic Surgery · 61d
Cleared Nov 20, 2023
Single Use Non-Stick McPherson Bipolar Forceps, 110mm, 0.5mm Tip with Cable...
K233351 · GEI
Hg Innovations, Ltd.
General & Plastic Surgery · 52d
Cleared Nov 20, 2023
Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 0.5mm Tip with...
K233346 · GEI
Hg Innovations, Ltd.
General & Plastic Surgery · 52d
Cleared Nov 20, 2023
Hair Removal Device, Model(s): R2815-G Pro, R2815-G
K232575 · OHT
Shenzhen Jianchao Intelligent...
General & Plastic Surgery · 87d
Cleared Nov 17, 2023
Celox Rapid X-Ray Gauze
K230589 · QSY
Medtrade Products , Ltd.
General & Plastic Surgery · 260d
Cleared Nov 17, 2023
Polyver Silver Alginate Dressing (Prescription and OTC)
K230190 · FRO
Roosin Medical Co., Ltd.
General & Plastic Surgery · 297d
Cleared Nov 16, 2023
NEUWAVE™ Microwave Ablation System and Accessories
K231738 · NEY
Neuwave Medical, Inc.
General & Plastic Surgery · 155d
Cleared Nov 15, 2023
CoolSeal Trinity
K231012 · GEI
Bolder Surgical, LLC
General & Plastic Surgery · 219d
Cleared Nov 14, 2023
IPL Cooling Hair Removal Device
K232845 · OHT
Shenzhen Siken 3D Technology...
General & Plastic Surgery · 61d
Cleared Nov 14, 2023
BLU TOTALE (Model: ENEOB852)
K232656 · OLP
Premier North America, Inc.
General & Plastic Surgery · 75d