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
2377–2400 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Ethicon, Inc. Lead specialty: General & Plastic Surgery
Cleared Aug 28, 2020
Hemostatic Xerogel Sponge
K192671 · QSY
Solaplus Biotech Co., Ltd.
General & Plastic Surgery · 337d
Cleared Aug 27, 2020
APTOS Threads – Polypropylene Surgical Sutures
K192953 · GAW
Aptos, LLC
General & Plastic Surgery · 311d
Cleared Aug 26, 2020
VersaOne Reusable Positioning Trocar System
K201805 · GCJ
Covidien
General & Plastic Surgery · 56d
Cleared Aug 26, 2020
Emprint Ablation System with Thermosphere Technology
K200796 · NEY
Covidien, LLC
General & Plastic Surgery · 153d
Cleared Aug 21, 2020
BTL-785F
K193201 · GEI
Btl
General & Plastic Surgery · 275d
Cleared Aug 20, 2020
FUJIFILM Video Laparoscope
K202130 · GCJ
Fujifilm Corporation
General & Plastic Surgery · 20d
Cleared Aug 19, 2020
Medline ReNewal Reprocessed Harmonic ACE+7 Shears
K193563 · NLQ
Surgical Instrument Service and...
General & Plastic Surgery · 240d
Cleared Aug 19, 2020
invisa-RED ELITE
K192275 · OLI
IR Technology, LLC
General & Plastic Surgery · 363d
Cleared Aug 18, 2020
Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System
K202012 · KNW
Devicor Medical Products, Inc.
General & Plastic Surgery · 28d
Cleared Aug 17, 2020
HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR...
K201399 · OWN
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 81d
Cleared Aug 12, 2020
Aurora Evacuator +Coag
K201637 · GEI
Rebound Therapeutics
General & Plastic Surgery · 57d
Cleared Aug 12, 2020
SNA-001 Silver Photoparticle Topical Gel
K192620 · QCY
Sienna Biopharmaceuticals, Inc.
General & Plastic Surgery · 324d
Cleared Aug 11, 2020
CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo...
K201588 · GEH
Varian Medical Systems, Inc.
General & Plastic Surgery · 60d
Cleared Aug 11, 2020
NuEra Tight, NuEra Tight EMS
K200359 · PBX
Bios S.R.L.
General & Plastic Surgery · 180d
Cleared Aug 06, 2020
Disposable Laparoscope Trocar
K201641 · GCJ
Beijing Biosis Healing Biolog Ical...
General & Plastic Surgery · 51d
Cleared Aug 06, 2020
VICRYL Mesh
K201143 · FTL
Ethicon, Inc.
General & Plastic Surgery · 99d
Cleared Aug 03, 2020
Electrodes Handpieces for Mygen V-1000 RF System
K193355 · GEI
RF Medical Co., Ltd.
General & Plastic Surgery · 243d
Cleared Jul 31, 2020
BiPad Hand Activated, Disposable Bipolar Electrocautery Cords
K201833 · GEI
Bipad Surgical, Inc.
General & Plastic Surgery · 29d
Cleared Jul 31, 2020
Reprocessed Endoscopic Trocars and Sleeves
K201511 · NLM
Stryker Sustainability Solutions
General & Plastic Surgery · 56d
Cleared Jul 31, 2020
Kendall NPWT Incision Management Dressing Kit
K191101 · OMP
Cardinalhealth
General & Plastic Surgery · 463d
Cleared Jul 29, 2020
Symphony
K200413 · KGN
Aroa Biosurgery , Ltd.
General & Plastic Surgery · 161d
Cleared Jul 28, 2020
Connected OR Hub with Voice Control, Connected OR Hub with Device Control
K201434 · GCJ
Stryker
General & Plastic Surgery · 57d
Cleared Jul 27, 2020
Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed
K201280 · GDW
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 75d
Cleared Jul 24, 2020
Single Use Electrosurgical Knife
K193601 · GEI
Micro-Tech (Nanjing) Co., Ltd.
General & Plastic Surgery · 214d