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
10369–10392 of 18,327
Search insights Median review: 84d Cleared: 100% Top manufacturer: Intuitive Surgical, Inc. Lead specialty: General & Plastic Surgery
Cleared Mar 05, 1997
S-SCORT (2500)
K964997 · BTA
Sscor
General & Plastic Surgery · 79d
Cleared Mar 04, 1997
CPI, MAXI-VAC(6480),THOMAS INDUSTRIES, MEDI-PUMP(1240/1242/1243)
K965059 · BTA
Thomas Industries
General & Plastic Surgery · 76d
Cleared Mar 03, 1997
RADIACARE ORAL WOUND RINSE
K964852 · OLR
Carrington Laboratories, Inc.
General & Plastic Surgery · 90d
Cleared Feb 28, 1997
CYBERLASE CO2 LASER SYSTEM
K964353 · GEX
Nidek, Inc.
General & Plastic Surgery · 119d
Cleared Feb 28, 1997
STRYKER SAPHENOUS VEIN HARVEST SCOPE
K964930 · GCJ
Stryker Endoscopy
General & Plastic Surgery · 81d
Cleared Feb 28, 1997
BIPOLAR SUCTION COAGULATOR
K965241 · GEI
Kirwan Surgical Products, Inc.
General & Plastic Surgery · 79d
Cleared Feb 27, 1997
BERGEN 610 BIPOLAR COAGULATOR
K964736 · GEI
Bergen Mfg.
General & Plastic Surgery · 94d
Cleared Feb 26, 1997
ENCORE ELECTROSURGICAL HANDCONTROL PENCIL (35001-001)
K970039 · GEI
Medtrex, Inc.
General & Plastic Surgery · 51d
Cleared Feb 25, 1997
ENDOCARE CRYOCARE CRYOSURGICAL SYSTEM URETHRAL WARMING SYSTEM
K963970 · GEH
Endocare, Inc.
General & Plastic Surgery · 145d
Cleared Feb 25, 1997
SUTURE LOCK
K964935 · KGS
Smith & Nephew Endoscopy, Inc.
General & Plastic Surgery · 77d
Cleared Feb 25, 1997
ENDOCARE ELECTROSURGICAL ELECTRODE
K965243 · GEI
Endocare, Inc.
General & Plastic Surgery · 64d
Cleared Feb 24, 1997
IAMIN IMPREGNATED GAUZE DRESSING
K965005 · MGQ
Procyte Corp.
General & Plastic Surgery · 70d
Cleared Feb 21, 1997
INDIGO MEDICAL MODEL IDL 830 & MODEL IDL 830E LASER SYSTEMS FOR GENERAL...
K963081 · GEX
Indigo Medical, Inc.
General & Plastic Surgery · 197d
Cleared Feb 19, 1997
SPACEMAKER SERIAL SURGICAL BALLOON DISSECTOR, WITH CANNULA, WITH...
K962702 · GCJ
General Surgical Innovations
General & Plastic Surgery · 222d
Cleared Feb 19, 1997
DORNIER MEDILAS FIBER TOME LASER
K964760 · GEX
Dornier Medtech America, Inc.
General & Plastic Surgery · 84d
Cleared Feb 18, 1997
ACCUCURE 3000
K964486 · GEX
Lasermed, Inc.
General & Plastic Surgery · 102d
Cleared Feb 18, 1997
RAPISEAL PATCH
K964857 · FTL
Fusion Medical Technologies, Inc.
General & Plastic Surgery · 76d
Cleared Feb 18, 1997
UNIMED COATED LAPAROSCOPIC/ARTHROSCOPY/SUCTION-IRRIGATION ELECTRODE
K970066 · GEI
Unimed Surgical Products, Inc.
General & Plastic Surgery · 41d
Cleared Feb 14, 1997
VASOVIEW BALLOON DISSECTION SYSTEM
K964171 · GCJ
Origin Medsystems, Inc.
General & Plastic Surgery · 119d
Cleared Feb 14, 1997
SOFTOUCH
K964684 · GEX
Sahar Technologies, Inc.
General & Plastic Surgery · 84d
Cleared Feb 14, 1997
PROD. NO. 01-132 - SUTURE REMOVAL KIT
K964827 · MCZ
Continental Medical Laboratories, Inc.
General & Plastic Surgery · 74d
Cleared Feb 14, 1997
CYGNUS ELECTROSURGICAL TIP CLEANER
K965086 · GEI
Madison Polymeric Engineering
General & Plastic Surgery · 57d
Cleared Feb 14, 1997
O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE
K965201 · LRO
Trinity Laboratories, Inc.
General & Plastic Surgery · 50d
Cleared Feb 14, 1997
GI SUPPLY PARACENTESIS PUMP
K970186 · BTA
Gi Supply
General & Plastic Surgery · 28d