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
3433–3456 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Ethicon, Inc. Lead specialty: General & Plastic Surgery
Cleared Jul 25, 2017
PHMB Antimicrobial Foam Wound Dressing
K163062 · FRO
Advanced Medical Solutions, Ltd.
General & Plastic Surgery · 265d
Cleared Jul 19, 2017
Disposable Standard Clamp
K170379 · GCJ
Standard Bariatrics
General & Plastic Surgery · 162d
Cleared Jul 19, 2017
XPress BCD Breast Compression Device
K163388 · POY
Xpress Bcd, LLC
General & Plastic Surgery · 229d
Cleared Jul 17, 2017
BD ChloraShield IV Dressing with CHG Antimicrobial
K170407 · FRO
Avery Dennison Belgie Bvba
General & Plastic Surgery · 157d
Cleared Jul 14, 2017
truFreeze Rapid AV Spray Kit
K171522 · GEH
CSA Medical, Inc.
General & Plastic Surgery · 50d
Cleared Jul 14, 2017
Alma LipoFlow System
K171242 · MUU
Alma Lasers, Inc.
General & Plastic Surgery · 78d
Cleared Jul 14, 2017
sensiFirm
K170637 · PBX
El Global Trade, Ltd.
General & Plastic Surgery · 134d
Cleared Jul 14, 2017
Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single...
K162707 · GDW
Golden Stapler Surgical Co., Ltd.
General & Plastic Surgery · 289d
Cleared Jul 12, 2017
NIRA Beauty Skin Laser
K163137 · OHS
Dermal Photonics Corporation
General & Plastic Surgery · 245d
Cleared Jul 11, 2017
3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing
K171908 · SEL
3M Company
General & Plastic Surgery · 15d
Cleared Jul 10, 2017
Biodesign Parastomal Hernia Repair Graft
K162934 · FTM
Cook Biotech Incorporated
General & Plastic Surgery · 263d
Cleared Jul 07, 2017
Thunder, Thunder VT, Thunder HR
K171711 · GEX
Quanta System Spa
General & Plastic Surgery · 28d
Cleared Jul 07, 2017
ZELTIQ CoolSculpting System
K171069 · OOK
Zeltiq Aesthetics, Inc.
General & Plastic Surgery · 88d
Cleared Jul 06, 2017
Dermal Cooling System
K171398 · GEH
R2 Dermatology ,Inc
General & Plastic Surgery · 55d
Cleared Jul 06, 2017
Philips BlueControl
K171055 · ONE
Philips Electronics Nederland B.V.
General & Plastic Surgery · 87d
Cleared Jul 06, 2017
CO2 Laser Therapy Systems
K162398 · ONG
Beijing Sincoheren Science and...
General & Plastic Surgery · 314d
Cleared Jul 06, 2017
HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux
K161394 · LEJ
Sportarredo Group S.C.
General & Plastic Surgery · 413d
Cleared Jul 03, 2017
Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector
K170955 · NLQ
Surgical Instrument Service and...
General & Plastic Surgery · 94d
Cleared Jul 03, 2017
DigniCap Scalp Cooling System
K170871 · PMC
Dignitana AB
General & Plastic Surgery · 102d
Cleared Jun 30, 2017
Infinity-Lock 3, Infinity-Lock 5
K171680 · GAT
Xiros, Ltd.
General & Plastic Surgery · 24d
Not Cleared Jun 30, 2017
D2 Dressing
DEN160012 · POD
Z-Medica, LLC
General & Plastic Surgery · 471d
Cleared Jun 29, 2017
Parietene DS Composite Mesh
K163212 · FTL
Sofradim Production
General & Plastic Surgery · 225d
Cleared Jun 28, 2017
SupraSDRM Biodegradable Matrix Wound Dressing
K170213 · QSZ
Polymedics Innovations, GmbH
General & Plastic Surgery · 155d
Cleared Jun 23, 2017
Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics
K171324 · NUJ
Surgical Instrument Service and...
General & Plastic Surgery · 49d