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
1969–1992 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Ethicon, Inc. Lead specialty: General & Plastic Surgery
Cleared Jan 06, 2022
ENEO TOTALE (Model: ENEOT947)
K213841 · OHS
Premier North America, Inc.
General & Plastic Surgery · 28d
Cleared Jan 05, 2022
BTL-899A
K213344 · GEI
BTL Industries, Inc.
General & Plastic Surgery · 90d
Cleared Jan 05, 2022
PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use...
K211318 · OMP
Smith & Nephew Medical Limited
General & Plastic Surgery · 250d
Cleared Jan 05, 2022
Urethral Warming Catheter Kit
K211149 · GEH
Varian Medical Systems, Inc.
General & Plastic Surgery · 261d
Cleared Jan 04, 2022
Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle
K213831 · GEI
Gyrus Acmi, Inc.
General & Plastic Surgery · 27d
Cleared Jan 04, 2022
InnoClip Disposable Clip Applier, InnoClip Clip Applier
K202994 · FZP
Taiwan Surgical Corporation
General & Plastic Surgery · 460d
Cleared Dec 30, 2021
Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable...
K211458 · GDW
Ningbo Verykind Medical Device Co., Ltd.
General & Plastic Surgery · 233d
Cleared Dec 30, 2021
Tzoar 207 Negative Pressure Wound Therapy (NPWT) System
K202898 · OMP
Lightstone Medical Products (Ningbo)...
General & Plastic Surgery · 457d
Cleared Dec 22, 2021
Diode Laser System GP900A8, Diode Laser System GP900Q8
K213225 · GEX
Shenzhen Gsd Tech Co., Ltd.
General & Plastic Surgery · 84d
Cleared Dec 22, 2021
ID-500 iRestore Hair Growth System
K213094 · OAP
Freedom Laser Therapy, Inc.
General & Plastic Surgery · 89d
Cleared Dec 22, 2021
Oren LED Perioral Light Therapy System
K213024 · OHS
Shenzhen Kaiyan Medical CO , Ltd.
General & Plastic Surgery · 92d
Cleared Dec 22, 2021
Non Absorbable Surgical Nylon Suture
K212603 · GAR
Shandong Haidike Medical Product Co.,...
General & Plastic Surgery · 127d
Cleared Dec 21, 2021
TheraFace LED
K212155 · OHS
Theragun, Inc.
General & Plastic Surgery · 162d
Cleared Dec 21, 2021
reVive Light Therapy Essentials
K210968 · OLP
Led Technologies, Inc.
General & Plastic Surgery · 265d
Cleared Dec 20, 2021
Frax 1940 for Nordlys and Frax Pro
K212492 · GEX
Candela Corporation
General & Plastic Surgery · 133d
Cleared Dec 20, 2021
3M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dressing Kit:...
K211521 · OMP
3M Healthcare Business Group
General & Plastic Surgery · 217d
Cleared Dec 20, 2021
IPL Home Use Hair Removal Device
K211185 · OHT
Shenzhen Beauty Every Moment...
General & Plastic Surgery · 244d
Cleared Dec 17, 2021
Single Use Electrosurgical Knife with Fluid Pump System
K211172 · GEI
Micro-Tech (Nanjing) Co., Ltd.
General & Plastic Surgery · 242d
Cleared Dec 17, 2021
PDO Max Suture with Dual Needle
K210871 · NEW
Pdo Max, Inc.
General & Plastic Surgery · 268d
Cleared Dec 17, 2021
MED RF 4000
K210077 · ONQ
F Care Systems USA, LLC
General & Plastic Surgery · 339d
Cleared Dec 16, 2021
IPL hair removal machine
K213020 · OHT
Shenzhen Borria Technology Co., Ltd.
General & Plastic Surgery · 87d
Cleared Dec 16, 2021
Connected OR Hub with Device and Voice Control
K212055 · GCJ
Stryker Corporation
General & Plastic Surgery · 168d
Cleared Dec 16, 2021
Theia NPWT Foam Wound Dressing Kit
K211277 · OMP
Clear Choice Therapeutics, Inc.
General & Plastic Surgery · 233d
Cleared Dec 16, 2021
Profound Matrix
K211217 · GEI
Candela Corporation
General & Plastic Surgery · 237d