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
1633–1656 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Intuitive Surgical, Inc. Lead specialty: General & Plastic Surgery
Cleared Nov 10, 2022
H1
K222504 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 84d
Cleared Nov 10, 2022
10PL
K220794 · ONF
Tentech Co. , Ltd.
General & Plastic Surgery · 237d
Cleared Nov 10, 2022
Dermal Cooling System
K213294 · QPZ
R2 Technologies, Inc.
General & Plastic Surgery · 405d
Cleared Nov 07, 2022
Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M,...
K222800 · GEX
Sanhe Laserconn Tech Co., Ltd.
General & Plastic Surgery · 52d
Cleared Nov 03, 2022
truSculpt iD
K223110 · GEI
Cutera, Inc.
General & Plastic Surgery · 31d
Cleared Nov 03, 2022
Led Mask Platinum Md
K222377 · OHS
Cellreturn Co., Ltd.
General & Plastic Surgery · 90d
Cleared Nov 03, 2022
Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie...
K222168 · FMK
Owen Mumford, Ltd.
General & Plastic Surgery · 105d
Cleared Nov 02, 2022
OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance and Assure Lance...
K222084 · FMK
Asahi Polyslider Co., Ltd.
General & Plastic Surgery · 110d
Cleared Nov 01, 2022
Back 3 COLOR
K214090 · PBX
Swims America Corp
General & Plastic Surgery · 308d
Cleared Oct 28, 2022
VS3-Iridium System (VS3-IR)
K223020 · OWN
Visionsense, Ltd.
General & Plastic Surgery · 29d
Cleared Oct 28, 2022
Disposable Safety Lancet
K221521 · FMK
SteriLance Medical (Suzhou), Inc.
General & Plastic Surgery · 156d
Cleared Oct 27, 2022
Arthrex BioSuture
K220880 · GAT
Arthrex, Inc.
General & Plastic Surgery · 216d
Cleared Oct 26, 2022
Silverlon Wound Contact, Burn Contact Dressings
K221218 · FRO
Argentum Medical, Inc.
General & Plastic Surgery · 182d
Cleared Oct 25, 2022
Unistik® Pro
K222303 · FMK
Owen Mumford, Ltd.
General & Plastic Surgery · 85d
Cleared Oct 24, 2022
SafetiCET Safety Lancet
K221783 · FMK
Nsp Tech Pte, Ltd.
General & Plastic Surgery · 125d
Cleared Oct 21, 2022
Collagen P.I.N. (Percutaneous Induction Needling)
K222199 · QAI
Induction Therapies, LLC
General & Plastic Surgery · 91d
Cleared Oct 21, 2022
Hair Removal Device (Model: IPL-D26, IPL-D19)
K221643 · OHT
Shenzhen Desida Technology Co., Ltd.
General & Plastic Surgery · 137d
Cleared Oct 20, 2022
da Vinci Firefly Imaging System
K222827 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 31d
Cleared Oct 20, 2022
SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NETWORK ENABLED (72205447),...
K221740 · GCJ
Smith and Nephew, Inc.
General & Plastic Surgery · 127d
Cleared Oct 19, 2022
RADIANCE ULTRA 32 4K ZEROWIRE DUO
K222890 · GCJ
Nds Surgical Imaging, LLC
General & Plastic Surgery · 26d
Cleared Oct 19, 2022
SOMAVAC 100 Sustained Vacuum System
K222856 · BTA
Somavac Medical Solutions, Inc.
General & Plastic Surgery · 28d
Cleared Oct 19, 2022
Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
K222643 · PBY
Sirius Medical Systems B.V.
General & Plastic Surgery · 48d
Cleared Oct 18, 2022
MEBO Wound Dressing
K222657 · FRO
Mebo Life Science, Inc.
General & Plastic Surgery · 46d
Cleared Oct 18, 2022
TRUEdraw Lancing Device, Mini Lancing Device
K221072 · QRL
Trividia Health
General & Plastic Surgery · 189d