Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: General & Plastic Surgery ×
18,368 results
1945–1968 of 18,368
Search insights Median review: 84d Cleared: 100% Top manufacturer: Intuitive Surgical, Inc. Lead specialty: General & Plastic Surgery
Cleared May 03, 2022
Intra.Ox 2.0 Handheld Tissue Oximeter
K221010 · MUD
Vioptix, Inc.
General & Plastic Surgery · 28d
Cleared May 03, 2022
ECHOLASER X4
K213594 · GEX
Elesta S.P.A
General & Plastic Surgery · 172d
Cleared Apr 29, 2022
GIA Stapler with Tri-Staple Technology
K221006 · GDW
Covidien
General & Plastic Surgery · 24d
Cleared Apr 29, 2022
EEA Circular Stapler with Tri-Staple Technology
K221005 · GDW
Covidien
General & Plastic Surgery · 24d
Cleared Apr 29, 2022
Accu-Chek FastClix Blood Lancing System
K220608 · QRL
Roche Diabetes Care, Inc.
General & Plastic Surgery · 58d
Cleared Apr 29, 2022
LISA Laser Surgical Fibers
K220189 · GEX
Omni-Guide Holdings, Inc.
General & Plastic Surgery · 95d
Cleared Apr 28, 2022
Geistlich Wound Matrix PLUS
K213607 · KGN
Geistlich Pharma AG
General & Plastic Surgery · 164d
Cleared Apr 27, 2022
Hand-held IPL device (JOVS Hair Removal Device)
K220645 · OHT
Shenzhen Qianyu Technology Co., Ltd.
General & Plastic Surgery · 54d
Cleared Apr 27, 2022
Venus BlissMAX
K220592 · PBX
Venus Concept USA, Inc.
General & Plastic Surgery · 57d
Cleared Apr 26, 2022
IPL Hair Removal Device, model(s): S1-A, S2-A, S1, S2, S3, S4
K220222 · OHT
Shenzhen Yuwei Electronic Technology...
General & Plastic Surgery · 90d
Cleared Apr 26, 2022
PERMALOOP Suture, PERMATAPE Suture
K220219 · GAT
Medos International SARL
General & Plastic Surgery · 90d
Cleared Apr 22, 2022
1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688...
K220895 · GCJ
Stryker
General & Plastic Surgery · 25d
Cleared Apr 22, 2022
1 Series Phototherapy Equipment
K220840 · FTC
Daavlin Distributing Co.
General & Plastic Surgery · 30d
Cleared Apr 22, 2022
PicoStar
K213889 · GEX
Asclepion Laser Technologies GmbH
General & Plastic Surgery · 130d
Cleared Apr 22, 2022
Promisemed Fine Biopsy Needle
K213683 · KNW
Promisemed Hangzhou Meditech Co., Ltd.
General & Plastic Surgery · 151d
Cleared Apr 22, 2022
LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel
K211123 · FRO
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 372d
Cleared CT Apr 22, 2022
CoNextions TR Tendon Repair System
K203855 · GAQ
Conextions Medical
General & Plastic Surgery · 477d
Cleared Apr 21, 2022
HydroMARK Breast Biopsy Site Marker
K212158 · NEU
Devicor Medical Products, Inc.
General & Plastic Surgery · 283d
Cleared Apr 21, 2022
Waterlase iPLus
K210183 · GEX
Biolase, Inc.
General & Plastic Surgery · 451d
Cleared Apr 20, 2022
Saberscope5 Laparoscope
K220872 · GCJ
Xenocor, Inc.
General & Plastic Surgery · 26d
Cleared Apr 20, 2022
Auxo A300, A150 and APod
K220543 · OAP
Auxo Hair, LLC
General & Plastic Surgery · 54d
Cleared Apr 20, 2022
GEM FLOW COUPLER Monitor (GEM1020M-2)
K213974 · DPW
Synovis Micro Companies Alliance, Inc.
General & Plastic Surgery · 121d
Cleared Apr 20, 2022
SmoothCool HR System
K213484 · GEX
Jeisys Medical, Inc.
General & Plastic Surgery · 173d
Cleared Apr 15, 2022
mJOULE System and Accessories
K213350 · GEX
Sciton, Inc
General & Plastic Surgery · 189d