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
7153–7176 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Ethicon, Inc. Lead specialty: General & Plastic Surgery
Cleared Jul 17, 2006
SURGICAL MESH SYSTEM
K053215 · FTL
Nuvasive, Inc.
General & Plastic Surgery · 242d
Cleared Jul 14, 2006
SYNERGY HIP SYSTEM
K061066 · LZO
Smith & Nephew, Inc.
General & Plastic Surgery · 88d
Cleared Jul 14, 2006
PDS PLUS ANTIBACTERIAL SUTURE
K061037 · NEW
Ethicon, Inc.
General & Plastic Surgery · 91d
Cleared Jul 14, 2006
TYRX ANTIMICROBIAL MESH
K053656 · FTL
Tyrx Pharma, Inc.
General & Plastic Surgery · 196d
Cleared Jul 12, 2006
TROKAMED GMBH ELECTROSURGICAL INSTRUMENTS & ACCESSORIES
K060232 · GEI
Trokamed GmbH
General & Plastic Surgery · 163d
Cleared Jul 11, 2006
BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM
K061788 · OMP
Boehringer Laboratories
General & Plastic Surgery · 15d
Cleared Jul 11, 2006
SIMEX SUCTION PUMP, MODELS AC20, AC20K, AC30, DC20, DC30 AND DC30S
K061133 · BTA
Novaspine, LLC
General & Plastic Surgery · 78d
Cleared Jul 10, 2006
DENLASER 800 PLUS
K061366 · GEX
CAO Group, Inc.
General & Plastic Surgery · 55d
Cleared Jul 07, 2006
HEMCON DENTAL DRESSING, 1 DRESSING, 4 DRESSING, 1 DRESSING, BOX OF 12, 4...
K060363 · OLR
Hemcon, Inc.
General & Plastic Surgery · 144d
Cleared Jul 06, 2006
LUMENIS ONE FAMILY OF SYSTEMS
K060448 · GEX
Lumenis, Ltd.
General & Plastic Surgery · 135d
Cleared Jul 05, 2006
COLLAWOUND DRESSING
K061474 · KGN
Collamatrix Co., Inc.
General & Plastic Surgery · 36d
Cleared Jul 05, 2006
ANCHOR BAND SUTURING SYSTEM, MODEL SR-AB
K061386 · GAT
Anulex Technologies, Inc.
General & Plastic Surgery · 48d
Cleared Jul 05, 2006
OCULASE MD
K052354 · GEX
Biolase Technology, Inc.
General & Plastic Surgery · 310d
Cleared Jul 03, 2006
SMOOTHSHAPES
K061603 · NUV
Biocellulase, Inc.
General & Plastic Surgery · 25d
Cleared Jul 03, 2006
STATARIUS, MODEL 001 003
K061292 · GCJ
Kinetic Surgical, LLC
General & Plastic Surgery · 55d
Cleared Jul 03, 2006
ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER, MODELS EC60, SC60 AND LONG60...
K061156 · GDW
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 68d
Cleared Jul 03, 2006
TT101, MODELS TT 101-1,-2,-3,-4,-5,-6,-7,-8
K061060 · FRO
Tissue Technologies Holdings, LLC
General & Plastic Surgery · 77d
Cleared Jul 03, 2006
EASYTAC ANCHOR. EASYTAC DELIVERY SYSTEM
K060494 · GDW
Medchannel, LLC
General & Plastic Surgery · 129d
Cleared Jun 29, 2006
PRIMATRIX DERMAL REPAIR SCAFFOLD
K061407 · KGN
Tei Biosciences, Inc.
General & Plastic Surgery · 38d
Cleared Jun 29, 2006
VASHE WOUND CLEANSING SYSTEM
K060901 · FRO
Sterilox Technologies, Inc.
General & Plastic Surgery · 87d
Cleared Jun 28, 2006
SURGI-MAX
K061174 · GEI
Ellman Int'L, Inc.
General & Plastic Surgery · 62d
Cleared Jun 26, 2006
ALLWOUND
K053476 · SEJ
At Squared, LLC
General & Plastic Surgery · 194d
Cleared Jun 23, 2006
ACELL POWDER WOUND DRESSING
K060888 · KGN
Acell, Inc.
General & Plastic Surgery · 84d
Cleared Jun 23, 2006
ZIMMER COLLAGEN REPAIR PATCH
K053562 · FTM
Tissue Science Laboratories, Plc
General & Plastic Surgery · 184d