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
9385–9408 of 18,327
Search insights Median review: 84d Cleared: 100% Top manufacturer: Intuitive Surgical, Inc. Lead specialty: General & Plastic Surgery
Cleared Jul 30, 1999
BLUNT TIP TROCAR PORT
K992353 · GCJ
Origin Medsystems, Inc.
General & Plastic Surgery · 16d
Cleared Jul 30, 1999
ELECTROSURGICAL PROBES FAMILY: LIGAMENT CHISELS, MICRO LIGAMENT CHISELS,...
K992408 · GEI
Oratec Interventions, Inc.
General & Plastic Surgery · 10d
Cleared Jul 29, 1999
UNI-LASER 425P DIODE LASER SYSTEM & ACCESSORIES
K991659 · GEX
Medart Corp.
General & Plastic Surgery · 76d
Cleared Jul 29, 1999
GORE-TEX DUALMESH BIOMATERIAL
K992189 · FTL
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 30d
Cleared Jul 27, 1999
CRYO-HIT II, MODELS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5
K991517 · GEH
Galil Medical , Ltd.
General & Plastic Surgery · 88d
Cleared Jul 20, 1999
CHROMOPHARE D 530 LDR SURGICAL LIGHT
K990656 · FSY
Berchtold Holding GmbH
General & Plastic Surgery · 141d
Cleared Jul 20, 1999
ENDOSCOPIC CAMERA
K991416 · GCJ
Genzyme Surgical Product (Genzyme...
General & Plastic Surgery · 88d
Cleared Jul 20, 1999
DENTAL 200, DENTAL 300, DENTAL 400, MODELS E-20, E-60, E-50
K991464 · GEX
Fisma, Inc.
General & Plastic Surgery · 84d
Cleared Jul 20, 1999
DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING
K991608 · KMF
Dermaphylyx, Inc.
General & Plastic Surgery · 71d
Cleared Jul 20, 1999
DERMAPHYLYX SUPER ABSORBENT FIBER DRESSING
K991609 · KMF
Dermaphylyx, Inc.
General & Plastic Surgery · 71d
Cleared Jul 20, 1999
CICACARE MANAGEMENT FOR SCARS
K991957 · MDA
Smith & Nephew, Inc.
General & Plastic Surgery · 40d
Cleared Jul 15, 1999
SHIELDEDTROCAR/CANNULA SYSTEM, MODEL 101-005-101
K991382 · GCJ
Genicon, LC
General & Plastic Surgery · 85d
Cleared Jul 15, 1999
DYNAREX DRAIN SPONGE
K991694 · KMF
Dynarex Corp.
General & Plastic Surgery · 58d
Cleared Jul 15, 1999
DYNAREX NON-WOVEN SPONGE
K991695 · KMF
Dynarex Corp.
General & Plastic Surgery · 58d
Cleared Jul 14, 1999
STRETTA INFLATABLE BASKET CATHETER ELECTRODE WITH ASPIRATION
K991291 · GEI
Conway Stuart Medical, Inc.
General & Plastic Surgery · 90d
Cleared Jul 14, 1999
SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH.
K991567 · FTM
Shelhigh, Inc.
General & Plastic Surgery · 70d
Cleared Jul 12, 1999
TROCAR SYSTEM ACCORDING TO HASSON
K990237 · GCJ
Olympus America, Inc.
General & Plastic Surgery · 169d
Cleared Jul 12, 1999
CRYO-HIT,MODELS ED1TO, EPITI, EP2TI, EP2T2, EP3T3, EP4T2, EPT3, EP4T4,EP5T2,...
K991272 · GEH
Galil Medical , Ltd.
General & Plastic Surgery · 90d
Cleared Jul 12, 1999
LASER SYSTEM RUBYSTAR WITH Q-SWITCH AND NORMAL MODE
K991285 · GEX
Aesculap-Meditec North America
General & Plastic Surgery · 88d
Cleared Jul 12, 1999
UNI-LASER 450P CO2 LASER SYSTEM & ACCESSORIES
K991297 · GEX
Medart Corp.
General & Plastic Surgery · 88d
Cleared Jul 12, 1999
VISTA ORPC WITH INFOMATIX INTRAOP SOFTWARE
K991303 · GCJ
Vista Medical Technologies, Inc.
General & Plastic Surgery · 87d
Cleared Jul 12, 1999
OMNISONICS FLEXIBLE FIBER OPTIC ENDOSCOPE AND COUPLER
K991377 · GCJ
Omnisonics Medical Technologies
General & Plastic Surgery · 82d
Cleared Jul 12, 1999
PARIETENE POLYPROPYLENE MESH
K991400 · FTL
Sofradim Production
General & Plastic Surgery · 81d
Cleared Jul 12, 1999
SCATTERFREE LATERAL EMITTING FIBER
K992083 · GEX
Laser Peripherals, LLC
General & Plastic Surgery · 21d