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
8833–8856 of 18,327
Search insights Median review: 84d Cleared: 100% Top manufacturer: Intuitive Surgical, Inc. Lead specialty: General & Plastic Surgery
Cleared May 31, 2001
ESU HANDSWITCHING PENCIL
K001442 · GEI
Surgex, Inc.
General & Plastic Surgery · 388d
Cleared May 31, 2001
LAPAROSCOPIC HAND PORT
K003871 · GCJ
Applied Medical Resources Corp.
General & Plastic Surgery · 167d
Cleared May 31, 2001
ULTRACISION HARMONIC SCALPEL BLADES, MODEL DH105,DH145,SH105, SH145,HC145
K010898 · LFL
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 66d
Cleared May 30, 2001
ENSIL FABRIC
K010675 · MDA
Gottfried Medical, Inc.
General & Plastic Surgery · 85d
Cleared May 30, 2001
VAL LUX 600 SURGICAL LIGHT (PLUS AND RS), MODEL ML600/S: SINGLE LIGHT HEAD,...
K010716 · FSY
Valmed Corp.
General & Plastic Surgery · 82d
Cleared May 30, 2001
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL ISI 1000
K011002 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 57d
Cleared May 30, 2001
FORTAFLEX SURGICAL SLING
K011027 · FTM
Organogenesis, Inc.
General & Plastic Surgery · 55d
Cleared May 30, 2001
SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE
K011105 · GAL
Qrc Consulting
General & Plastic Surgery · 49d
Cleared May 25, 2001
AMBU GEL, HYDROGEL BURN DRESSING
K010583 · MGQ
Ambu, Inc.
General & Plastic Surgery · 87d
Cleared May 24, 2001
BIOSLING - BIOABSORBABLE POLYMER SLING & SURGICAL MESH
K010533 · FTL
Injectx, Inc.
General & Plastic Surgery · 90d
Cleared May 22, 2001
PHOTON MULTI-PLATFORM SYSTEM, MODEL Z-12834-X & Z-13175-X
K003318 · GEX
Paradigm Medical Industries, Inc.
General & Plastic Surgery · 210d
Cleared May 22, 2001
AFX MICROWAVE GENERATOR, FLEX ABLATION WAND, LYNX ABLATION WAND, MODEL SERIES...
K003978 · NEY
Afx, Inc.
General & Plastic Surgery · 151d
Cleared May 22, 2001
PALOMAR SLP 1000
K010580 · GEX
Palomar Medical Technologies, Inc.
General & Plastic Surgery · 84d
Cleared May 21, 2001
SYMMETRY AORTIC CLIP SYSTEM
K003446 · NCA
St. Jude Medical Cardiovascular...
General & Plastic Surgery · 196d
Cleared May 21, 2001
LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIES
K010834 · GEX
Laserscope
General & Plastic Surgery · 62d
Cleared May 21, 2001
MODIFICATION TO SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
K010936 · OXD
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 54d
Cleared May 18, 2001
MONOGRAMS SYNTHETIC MONOFILAMENT ABSORBABLE SUTURE
K010672 · GAM
Gramsmed, LLC
General & Plastic Surgery · 73d
Cleared May 18, 2001
MEGABEAM/CERALAS NON STERILE FIBER OPTIC LASER DELIVERY SYSTEMS, MODEL...
K010689 · GEX
Biolitec, Inc.
General & Plastic Surgery · 71d
Cleared May 18, 2001
SEEDLING ENTERPRISES LLC, COOL TEC MONOPOLAR AND BIPOLAR REUSABLE ELECTRODES
K010710 · GEI
Seedling Enterprises., LLC
General & Plastic Surgery · 70d
Cleared May 17, 2001
ENDOSCOPIC STAPLE REMOVAL INSTRUMENT
K010620 · GCJ
Onux Medical, Inc.
General & Plastic Surgery · 77d
Cleared May 14, 2001
DENSTAT
K010465 · GEI
Elmed, Inc.
General & Plastic Surgery · 87d
Cleared May 14, 2001
MAGNUM FLOW IRRIGATION SYSTEM
K010519 · GCJ
Scion Valley, Inc.
General & Plastic Surgery · 81d
Cleared May 14, 2001
ARTHREX FIBERWIRE, MODEL SPU-02NB-3800
K010673 · GAT
Arthrex, Inc.
General & Plastic Surgery · 69d
Cleared May 14, 2001
MODIFICATION TO IMPLANTABLE CLIP
K011236 · FZP
Applied Medical Resources Corp.
General & Plastic Surgery · 21d