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
1825–1848 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Ethicon, Inc. Lead specialty: General & Plastic Surgery
Cleared Jun 06, 2022
Diacare 7000
K211207 · PBX
Globus Sport and Health Technologies,...
General & Plastic Surgery · 410d
Cleared Jun 03, 2022
MICROLET NEXT lancing device, MICROLET Lancet
K220633 · QRL
Ascensia Diabetes Care U.S., Inc.
General & Plastic Surgery · 91d
Cleared Jun 03, 2022
Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle,...
K214063 · KNW
Guangzhou Shengwei Medical Devices...
General & Plastic Surgery · 158d
Cleared Jun 03, 2022
Multifrax Laser System
K213332 · ONG
Paradigm Medical Corporation
General & Plastic Surgery · 240d
Cleared Jun 03, 2022
SILKRO
K210084 · GEI
Hironic Co., Ltd.
General & Plastic Surgery · 507d
Cleared Jun 02, 2022
IPL Hair Removal
K220927 · OHT
Shenzhen Qiaochengli Technology Co.,...
General & Plastic Surgery · 63d
Cleared Jun 02, 2022
Leaseir MHR Xcell
K214049 · GEX
Leaseir Technologies, Slu
General & Plastic Surgery · 157d
Cleared Jun 02, 2022
EpilME
K213261 · GEX
Neauvia North America
General & Plastic Surgery · 245d
Cleared Jun 01, 2022
IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C
K221002 · OHT
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 58d
Cleared Jun 01, 2022
Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System
K210107 · OMP
Genadyne Biotechnologies, Inc.
General & Plastic Surgery · 502d
Cleared May 31, 2022
Fibrillar Collagen Wound Dressing
K213341 · KGN
Collagen Matrix, Inc.
General & Plastic Surgery · 236d
Cleared May 31, 2022
Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit
K211571 · OMP
Zhejiang Longterm Medical Technology...
General & Plastic Surgery · 375d
Cleared May 31, 2022
IRRIGO Wound Wash Jet System
K210987 · FQH
Inopro, Inc.
General & Plastic Surgery · 425d
Cleared May 27, 2022
Senhance Surgical System
K220889 · NAY
Asensus Surgical, Inc.
General & Plastic Surgery · 60d
Cleared May 26, 2022
Laser Hair Growth Comb
K213027 · OAP
Kam Yuen Plastic Products , Ltd.
General & Plastic Surgery · 247d
Cleared May 25, 2022
InnoVoyce Laser Fiber
K220793 · GEX
Innovoyce, LLC
General & Plastic Surgery · 68d
Cleared May 25, 2022
Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019)
K220481 · GEI
Stryker Sustainability Solutions
General & Plastic Surgery · 96d
Cleared May 25, 2022
780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and...
K214046 · GCJ
Stryker
General & Plastic Surgery · 149d
Cleared May 25, 2022
Micro-current facial cold and hot service (model: TPML-100)
K213039 · OLP
Li-Tek Electronics Technology C0., Ltd.
General & Plastic Surgery · 245d
Cleared May 25, 2022
Renuvion Dermal Handpiece, Renuvion Dermal System
K211652 · GEI
Apyx Medical Corporation(Formerly...
General & Plastic Surgery · 362d
Cleared May 24, 2022
Medline General Surgery Tray
K213481 · LRO
Medline Industries, Inc.
General & Plastic Surgery · 207d
Cleared May 23, 2022
LiquiBand XL
K211878 · OMD
Advanced Medical Solutions Limited
General & Plastic Surgery · 336d
Cleared May 20, 2022
Diode Laser Therapy Systems
K220381 · GEX
Beijing Lasertell Medical Co., Ltd.
General & Plastic Surgery · 99d
Cleared May 20, 2022
Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light...
K210545 · OLP
Marci Beauty, Inc.
General & Plastic Surgery · 449d