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
7825–7848 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Ethicon, Inc. Lead specialty: General & Plastic Surgery
Cleared May 12, 2004
ALVEOLUS INC. TB-STS TRACHEOBRONCHIAL STENT SYSTEM
K033990 · JCT
Alveolus, Inc.
General & Plastic Surgery · 141d
Cleared May 11, 2004
NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND
K040208 · QSY
Tz Medical, Inc.
General & Plastic Surgery · 102d
Cleared May 11, 2004
LASER ENDOSCOPIC DECOMPRESSION KIT, MODEL 1100, AND PERCUTANEOUS DISCECTOMY...
K040424 · GEX
Clarus Medical, LLC
General & Plastic Surgery · 83d
Cleared May 10, 2004
COMPRESSION ANASTOMOSIS CLIP (CAC)
K033324 · FZP
Niti Medical Technologies , Ltd.
General & Plastic Surgery · 208d
Cleared May 10, 2004
COLLAGEN WOUND DRESSING - ORAL
K040403 · KGN
Collagen Matrix, Inc.
General & Plastic Surgery · 83d
Cleared May 10, 2004
SURELINE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS
K040602 · FZP
Design Standards Corp.
General & Plastic Surgery · 63d
Cleared May 05, 2004
COOLAN 300
K030810 · GEX
Coolanalgesia , Ltd.
General & Plastic Surgery · 419d
Cleared May 05, 2004
LASERPRO DIODE LASER SYSTEMS, MODELS 810, 940 & 980
K040294 · GEX
Photo Medex, Inc.
General & Plastic Surgery · 89d
Cleared May 05, 2004
ULTRACINCH ABLATION DEVICE, ULTRACINCH ACCESSORY PACK, MODELS UC-8, UC-9,...
K040641 · NTB
Epicor Medical, Inc.
General & Plastic Surgery · 56d
Cleared May 05, 2004
INTUITIVE SURGICAL ENDOPASS ENDOSCOPIC DELIVERY INSTRUMENT, MODEL P/N 400170
K040948 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 23d
Cleared Apr 30, 2004
SMARTLITE D FREQUENCY DOUBLED ND:YAG LASER
K040289 · GEX
Cynosure, Inc.
General & Plastic Surgery · 84d
Cleared Apr 29, 2004
KENDALL ULTEC PRO AG+ HYDROCOLLOID DRESSING
K033453 · FRO
Tyco Healthcare
General & Plastic Surgery · 182d
Cleared Apr 29, 2004
ATRAMAT AND SORB-FAST POLYGLYCOLIC ACID
K040282 · GAM
Internacional Farmaceutica, S.A. DE C.V.
General & Plastic Surgery · 83d
Cleared Apr 29, 2004
MODIFICATION TO PARIETEX COMPOSITE (PCO) MESH
K040998 · FTL
Sofradim Production
General & Plastic Surgery · 10d
Cleared Apr 28, 2004
CONCERTO BIPOLAR NEEDLE ELECTRODE
K040785 · GEI
Boston Scientific Corp
General & Plastic Surgery · 30d
Cleared Apr 28, 2004
RITA SYSTEMS
K040989 · GEI
Rita Medical Systems
General & Plastic Surgery · 12d
Cleared Apr 23, 2004
CRYO 5
K040727 · GEX
Zimmer Elektromedizin GmbH
General & Plastic Surgery · 32d
Cleared Apr 23, 2004
COALESCENT SURGICAL U-CLIP AND ACCESSORIES
K040821 · FZP
Coalescent Surgical
General & Plastic Surgery · 24d
Cleared Apr 22, 2004
RESOLUTION HEMOSTASIS CLIPPING DEVICE
K040148 · MCH
Boston Scientific Corp
General & Plastic Surgery · 90d
Cleared Apr 22, 2004
NMX-1000
K040584 · GEI
Neomedix Corp.
General & Plastic Surgery · 48d
Cleared Apr 20, 2004
COOLTOUCH
K040131 · GEX
New Star Lasers, Inc.
General & Plastic Surgery · 90d
Cleared Apr 16, 2004
MICROVASCULAR ANASTOMOTIC DEVICE
K040163 · MVR
Synovis Micro Companies Alliance, Inc.
General & Plastic Surgery · 81d
Cleared Apr 16, 2004
INSTRUMED LAPAROSCOPE AND ACCESSORIES
K040855 · GEI
Instrumed International, Inc.
General & Plastic Surgery · 14d
Cleared Apr 15, 2004
RECLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0012
K033183 · GEX
Curelight, Ltd.
General & Plastic Surgery · 197d