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
3481–3504 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Intuitive Surgical, Inc. Lead specialty: General & Plastic Surgery
Cleared Jun 08, 2017
NEXA Negative Pressure Wound Therapy System
K162610 · OMP
Nexa Medical , Ltd.
General & Plastic Surgery · 262d
Cleared Jun 07, 2017
SurgiMend PRS Meshed, Revize-X
K171357 · OXH
Integra Lifesciences Corporation...
General & Plastic Surgery · 29d
Cleared Jun 06, 2017
Magnetic Surgical System
K171429 · PNL
Levita Magnetics International Corp
General & Plastic Surgery · 22d
Cleared Jun 06, 2017
CURVE Laser System
K170709 · OLI
Yolo Medical, Inc.
General & Plastic Surgery · 90d
Cleared Jun 02, 2017
Radiopaque Tissue Marker
K170026 · NEU
Viscus Biologics, LLC
General & Plastic Surgery · 150d
Cleared Jun 02, 2017
LS-5 ePTFE Suture
K163639 · NBY
Lsi Solutions
General & Plastic Surgery · 161d
Cleared Jun 02, 2017
KeraStat(R) Gel
K162759 · KGN
Keranetics, LLC
General & Plastic Surgery · 245d
Cleared Jun 01, 2017
Xenocor Xenoscope Laparoscopic System
K171344 · GCJ
Xenocor, Inc.
General & Plastic Surgery · 24d
Cleared May 31, 2017
EndoWrist Stapler 45 System and Stapler 45 Reloads
K171388 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 20d
Cleared May 31, 2017
Modified Alma Lasers Soprano XL Family of Multi-Application &...
K170626 · GEX
Alma Lasers, Inc.
General & Plastic Surgery · 90d
Cleared May 31, 2017
OptiFix AT Absorbable Fixation System with Articulating Technology - 30...
K170278 · GDW
C.R. Bard, Inc.
General & Plastic Surgery · 121d
Cleared May 30, 2017
27HJ713S
K170899 · GCJ
Lg Electronics
General & Plastic Surgery · 64d
Cleared May 26, 2017
SutureTape
K171296 · GAT
Arthrex, Inc.
General & Plastic Surgery · 24d
Cleared May 26, 2017
da Vinci X Surgical System
K171294 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 24d
Cleared May 25, 2017
KARL STORZ ICG Imaging System
K171238 · OWN
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 28d
Cleared May 25, 2017
PicoWay Laser System
K170597 · GEX
Syneron Candela Corporation
General & Plastic Surgery · 86d
Cleared May 24, 2017
truFreeze System
K163244 · GEH
CSA Medical, Inc.
General & Plastic Surgery · 187d
Cleared May 24, 2017
Cook Holmium Laser Fiber
K163197 · GEX
Cook Incorporated
General & Plastic Surgery · 190d
Cleared May 24, 2017
ACTION II Laser System
K163196 · GEX
Lutronic Corporation
General & Plastic Surgery · 190d
Cleared May 23, 2017
Skylit Phototherapy System
K170489 · FTC
Skylit Medical
General & Plastic Surgery · 95d
Cleared May 23, 2017
Prontosan Wound Gel
K163430 · FRO
B.Braun Medical, Inc.
General & Plastic Surgery · 167d
Cleared May 22, 2017
Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories
K170121 · GEX
Lumenis, Ltd.
General & Plastic Surgery · 129d
Cleared May 19, 2017
PK AIM
K170908 · GEI
Gyrus Acmi, Inc.
General & Plastic Surgery · 52d
Cleared May 19, 2017
AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded...
K163261 · FZP
AtriCure, Inc.
General & Plastic Surgery · 179d