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
11353–11376 of 18,327
Search insights Median review: 84d Cleared: 100% Top manufacturer: Intuitive Surgical, Inc. Lead specialty: General & Plastic Surgery
Cleared Mar 01, 1995
BERGEN 710 ESU
K945861 · HAM
Bergen Mfg.
General & Plastic Surgery · 90d
Cleared Mar 01, 1995
DUMEX WET DRESSINGS
K950132 · FRO
Dumex Medical Surgical Products, Ltd.
General & Plastic Surgery · 47d
Cleared Mar 01, 1995
SURGICAL BUR
K950449 · GFF
Transidyne General Corp.
General & Plastic Surgery · 26d
Cleared Feb 28, 1995
CLEAN AIR
K943201 · GEX
Wallach Surgical Devices, Inc.
General & Plastic Surgery · 238d
Cleared Feb 27, 1995
BIAFINE
K943910 · MGQ
Laboratoire Medix
General & Plastic Surgery · 200d
Cleared Feb 27, 1995
DERMAGRAN WOUND CLEANSER WITH ZINC
K945802 · KMF
Derma Sciences, Inc.
General & Plastic Surgery · 91d
Cleared Feb 27, 1995
IVALON EXTERNAL SPONGE
K946015 · NAB
Ivalon
General & Plastic Surgery · 80d
Cleared Feb 27, 1995
DERMASSIST(TM) HYDROGEL SATURATED GAUZE DRESSING
K946030 · MGQ
Wilshire Medical Products
General & Plastic Surgery · 80d
Cleared Feb 27, 1995
DERMASSIST(TM) HYDROGEL SATURATEED NON WOVEN DRESSING
K946031 · MGQ
Wilshire Medical Products
General & Plastic Surgery · 80d
Cleared Feb 24, 1995
TOUCH FOCUS 200MM DEFOCUSING HANDPIECE
K945178 · GEX
Plc Medical Systems, Inc.
General & Plastic Surgery · 123d
Cleared Feb 24, 1995
ACCU-BEAM C02 LASER HANDPIECE
K945648 · GEX
Tti Medical
General & Plastic Surgery · 99d
Cleared Feb 24, 1995
LASERSPRAY(TM)
K950248 · GEX
Biolase Technology, Inc.
General & Plastic Surgery · 35d
Cleared Feb 24, 1995
MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
K950503 · GCJ
United States Surgical, A Division of...
General & Plastic Surgery · 18d
Cleared Feb 24, 1995
50MM HANDPIECE
K950505 · GEX
Plc Medical Systems, Inc.
General & Plastic Surgery · 18d
Cleared Feb 24, 1995
NEEDLE/CANNULA
K950574 · LRO
Tri-Med Specialties, Inc.
General & Plastic Surgery · 28d
Cleared Feb 23, 1995
OPTUS LAPAROSCOPES AND OPERATING LAPAROSCOPES
K945266 · GCJ
Optus, Inc.
General & Plastic Surgery · 118d
Cleared Feb 23, 1995
ENDCUP
K945862 · GCJ
Lewtek
General & Plastic Surgery · 84d
Cleared Feb 23, 1995
LEVEEN NEEDLE ELECTRODE(TM)
K950347 · GEI
Radiotherapeutics Corp.
General & Plastic Surgery · 27d
Cleared Feb 23, 1995
BASIC REUSABLE TROCAR SYSTEM
K950500 · GCJ
Endoscopic Concepts, Inc.
General & Plastic Surgery · 17d
Cleared Feb 21, 1995
PHOTOTHERAPEUTIX MODEL 800B
K933952 · FTC
Avex Industries , Ltd.
General & Plastic Surgery · 558d
Cleared Feb 21, 1995
PHOTOTHERAPEUTIX MODEL 1650B
K933953 · FTC
Avex Industries , Ltd.
General & Plastic Surgery · 558d
Cleared Feb 21, 1995
PHOTOTHERAPEUTIX MODEL 2400B
K933954 · FTC
Avex Industries , Ltd.
General & Plastic Surgery · 558d
Cleared Feb 21, 1995
SINOJET MAXILLARY SINUS PUNCTURE & IRRIGATION SYSTEM
K942495 · KAM
Atos Medical AB
General & Plastic Surgery · 280d
Cleared Feb 21, 1995
SURGICAL SAW BLADES
K950403 · GFA
Transidyne General Corp.
General & Plastic Surgery · 21d