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.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: General & Plastic Surgery ×
18,327 results
8809–8832 of 18,327
Search insights Median review: 84d Cleared: 100% Top manufacturer: Intuitive Surgical, Inc. Lead specialty: General & Plastic Surgery
Cleared Jul 10, 2001
MODULAR VALVE HANDLES FOR ADAPTABLE TUBES, MODEL 1298-XX-XX, 1295-XX-XX
K011997 · GCJ
Pajunk GmbH
General & Plastic Surgery · 13d
Cleared Jul 09, 2001
CANDELA SPTL-1E PULSED DYE LASER
K011092 · GEX
Candela Corp.
General & Plastic Surgery · 90d
Cleared Jul 03, 2001
WATERLASE, MILLENNIUM
K011041 · GEX
Biolase Technology, Inc.
General & Plastic Surgery · 89d
Cleared Jun 29, 2001
LIPOMATIC
K010311 · QPB
Euromi S.A
General & Plastic Surgery · 148d
Cleared Jun 29, 2001
AESCULAP, INC., MONOSYN SYNTHETIC ABSORBABLE SURGICAL SUTURE
K011375 · GAM
Aesculap, Inc.
General & Plastic Surgery · 56d
Cleared Jun 28, 2001
MODIFICATION TO KSEA ENDOTIP SYSTEM
K011359 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 56d
Cleared Jun 22, 2001
CHESS HAND SURGERY SYSTEM
K010184 · MDM
Canica Design, Inc.
General & Plastic Surgery · 154d
Cleared Jun 22, 2001
AMS SLING FIXATION SYSTEM
K010990 · GAW
American Medical Systems, Inc.
General & Plastic Surgery · 80d
Cleared Jun 22, 2001
MEDLITE Q-SWITCHED ND:YAG LASER REPLACED BY THE MEDLITE C3 Q-SWTICHED ND:YAG...
K011677 · GEX
Continuum Electro-Optics, Inc.
General & Plastic Surgery · 23d
Cleared Jun 20, 2001
THIN FILM DRESSING FOR ULTRASOUND EXAM
K011284 · ITX
Martin E. Wendelken
General & Plastic Surgery · 54d
Cleared Jun 19, 2001
MODIFICATION TO PROLITE PULSED LIGHT SYSTEM
K010927 · GEX
Medical Bio Care Sweden AB
General & Plastic Surgery · 83d
Cleared Jun 19, 2001
PROLITE VL PULSED LIGHT SYSTEM
K010928 · GEX
Medical Bio Care Sweden AB
General & Plastic Surgery · 83d
Cleared Jun 19, 2001
ARTHROCARE CONTROLLER, MODEL H2000
K011634 · GEI
Arthrocare Corp.
General & Plastic Surgery · 21d
Cleared Jun 18, 2001
LAP DISC 120 X 120, MODEL LD111, LAP DISC 120 X 100, MODEL LD112, LAP DISC 70...
K010870 · GCJ
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 87d
Cleared Jun 15, 2001
NTERO NOMAD SYSTEM
K010815 · GEI
Ntero Surgical, Inc.
General & Plastic Surgery · 88d
Cleared Jun 15, 2001
OMNIPORT HAND AND INSTRUMENT ACCESS DEVICE
K011183 · GCJ
Advanced Surgical Concepts (Asc)
General & Plastic Surgery · 58d
Cleared Jun 14, 2001
SLT LASERPRO CTH HOLMIUM LASER SYSTEM
K011409 · GEX
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 37d
Cleared Jun 13, 2001
FORTADERM WOUND DRESSING
K011026 · KGN
Organogenesis, Inc.
General & Plastic Surgery · 70d
Cleared Jun 13, 2001
TRUMPF SURGICAL LIGHTS, MODELS 301,501,701,1001
K011693 · FSY
Trumpf Medical Systems, Inc.
General & Plastic Surgery · 13d
Cleared Jun 11, 2001
EN BLOC BIOPSY SYSTEM
K003190 · GEI
Neothermia Corp.
General & Plastic Surgery · 243d
Cleared Jun 11, 2001
ISLAND WOUND DRESSING WITH MICROBAN
K010951 · FRO
Island Dressing, LLC
General & Plastic Surgery · 75d
Cleared Jun 08, 2001
ARDO SUCTION PUMP MASTER, MODEL 30.00.XX
K011601 · BTA
Ardo Medical AG
General & Plastic Surgery · 15d
Cleared Jun 07, 2001
SOLA 700,SOLA 500, SOLA 300
K010724 · FTD
Drager Medizintechnik GmbH
General & Plastic Surgery · 87d
Cleared Jun 07, 2001
UNI-LASER 470
K010885 · GEX
Medart Corp.
General & Plastic Surgery · 76d