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
6145–6168 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Intuitive Surgical, Inc. Lead specialty: General & Plastic Surgery
Cleared May 28, 2009
DISPOSABLE HANDLE ASSEMBLES, MODELS DH0100 AND DH0500 SERIES
K090979 · GCJ
Encision, Inc.
General & Plastic Surgery · 51d
Cleared May 27, 2009
XYLOS POROUS SURGICAL MESH
K090880 · FTM
Xylos Corporation
General & Plastic Surgery · 57d
Cleared May 22, 2009
FREEHAND
K090340 · GCJ
Prosurgics Limited
General & Plastic Surgery · 101d
Cleared May 20, 2009
APLION TOPICAL CARE SYSTEM
K091133 · NAD
Aplion Medical,Llc
General & Plastic Surgery · 30d
Cleared May 20, 2009
OCULUS MICROCYN WOUND GEL
K090725 · FRO
Oculus Innovative Sciences, Inc.
General & Plastic Surgery · 62d
Cleared May 20, 2009
SUPRATHEL WOUND AND BURN DRESSING
K090160 · QSZ
Polymedics Innovations, GmbH
General & Plastic Surgery · 118d
Cleared May 20, 2009
ZELTIQ SYSTEM
K090094 · GEX
Zeltiq Aesthetics
General & Plastic Surgery · 126d
Cleared May 18, 2009
INTELLIGENT POWER UNIT, INTELLIGENT CONSOLE, INTELLIGENT DELIVERY SYSTEM,...
K091215 · GDW
Power Medical Interventions, Inc.
General & Plastic Surgery · 21d
Cleared May 18, 2009
ALGISEAL PAD
K091194 · QSY
Evolution Medical Technologies, LLC
General & Plastic Surgery · 25d
Cleared May 18, 2009
LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE, MODEL ZLK-100
K083455 · MUU
Medi-Khan USA, Inc.
General & Plastic Surgery · 178d
Cleared May 15, 2009
LOTUS II PULSED ER: YAG LASER SYSTEM
K083253 · GEX
Laseroptek Co., Ltd.
General & Plastic Surgery · 192d
Cleared May 14, 2009
ABTHERA OPEN ABDOMEN DRESSING, MODEL: M8275026
K090489 · FTL
Kci USA, Inc.
General & Plastic Surgery · 78d
Cleared May 14, 2009
AUTOSUTURE PROTACK
K090470 · OCW
Covidien
General & Plastic Surgery · 80d
Cleared May 14, 2009
AONGEN COLLAGEN MATRIX
K080868 · KGN
Aeon Astron Europe B.V.
General & Plastic Surgery · 412d
Cleared May 13, 2009
ELITE MPX LASER SYSTEM WITH CRYO C
K091169 · GEX
Cynosure, Inc.
General & Plastic Surgery · 21d
Cleared May 11, 2009
SOCKIT! AND MCMERLIN DERMAL WOUND GEL
K090092 · FRO
Mcmerlin Dental Products LP
General & Plastic Surgery · 117d
Cleared May 11, 2009
REFINE LIFT SYSTEM
K083102 · FTL
Alure Medical, Inc.
General & Plastic Surgery · 203d
Cleared May 08, 2009
CUSA SHEAR TIP, AN ACCESSORY OF THE CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR...
K090864 · LFL
Integra Radionics, Inc.
General & Plastic Surgery · 39d
Cleared May 07, 2009
INNOPORT LAPAROSCOPIC ACCESS DEVICE
K090677 · GCJ
Innovia, LLC
General & Plastic Surgery · 52d
Cleared May 07, 2009
ELLMAN INTERNATIONAL NON-ABLATIVE TECHNIQUE FOR SURGITRON IEC
K082834 · GEI
Ellman Int'L, Inc.
General & Plastic Surgery · 223d
Cleared May 07, 2009
INTUITIVE SURGICAL ENDOWRIST ONE HOT SHEARS INSTRUMENT
K082497 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 251d
Cleared May 06, 2009
PARIETEX MONOFILAMENT POLYESTER MESH
K090858 · FTL
Sofradim Production
General & Plastic Surgery · 37d
Cleared May 06, 2009
LARIAT II SUTURE DELIVERY DEVICE
K090385 · GAT
Sentreheart, Inc.
General & Plastic Surgery · 78d
Cleared May 05, 2009
ORTHADAPT PR
K090288 · FTL
Pegasus Biologics, Inc.
General & Plastic Surgery · 89d