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
8065–8088 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Ethicon, Inc. Lead specialty: General & Plastic Surgery
Cleared Aug 01, 2003
AURORA DS
K031988 · GEX
Syneron Medical, Ltd.
General & Plastic Surgery · 35d
Cleared Aug 01, 2003
AURORA SR
K031993 · GEX
Syneron Medical, Ltd.
General & Plastic Surgery · 35d
Cleared Aug 01, 2003
MODIFICATION TO THERMACOOL TC SYSTEM
K032088 · GEI
Thermage, Inc.
General & Plastic Surgery · 25d
Cleared Jul 29, 2003
VIRTUOSAPH
K031891 · GCJ
Terumo Cardiovascular Systems Corp.
General & Plastic Surgery · 46d
Cleared Jul 29, 2003
STELLARTECH COAGULATION SYSTEM, MODELS (1100C-115 & 1100C-230)
K032062 · GEI
Stellartech Research Corp.
General & Plastic Surgery · 26d
Cleared Jul 28, 2003
SINCLAIR WOUND AND SKIN EMULSION
K024367 · MGQ
Sinclair Pharmaceuticals, Ltd.
General & Plastic Surgery · 209d
Cleared Jul 28, 2003
AIRBRUSH LIPOSCULPTOR SYSTEM
K031881 · QPB
Biosculpture Technology, Inc.
General & Plastic Surgery · 40d
Cleared Jul 28, 2003
DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
K031969 · FTM
DePuy Orthopaedics, Inc.
General & Plastic Surgery · 32d
Cleared Jul 25, 2003
CONMED INTEGRATED SYSTEMS NURSES ASSISTANT
K031979 · FSY
Conmed Integrated Systems (Cmis)
General & Plastic Surgery · 29d
Cleared Jul 23, 2003
NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 &...
K031173 · GDF
Needle Tech Products, Inc.
General & Plastic Surgery · 100d
Cleared Jul 21, 2003
LUMENIS FAMILY OF DISPOSABLE CONTACT TIP DELIVERY DEVICES
K030033 · GEX
Lumenis, Ltd.
General & Plastic Surgery · 199d
Cleared Jul 21, 2003
ORLON NONABSORABLE SURGICAL SUTURE USP
K030177 · GAR
Sri Orion Pharmaceuticals & Sutures
General & Plastic Surgery · 185d
Cleared Jul 21, 2003
FAST THROW STAINLESS STEEL SURGICAL SUTURE
K030926 · FZP
Advanced Surgical Products, Inc.
General & Plastic Surgery · 119d
Cleared Jul 21, 2003
GYRUS PLASMAKINETIC SUPERPULSE SYSTEM (GENERATOR, ACCESSORIES)
K031085 · GEI
Gyrus Medical, Inc.
General & Plastic Surgery · 108d
Cleared Jul 21, 2003
CARDIOVATIONS OPTICAL BIPOLAR DEVICE
K031846 · GEI
Ethicon, Inc.
General & Plastic Surgery · 35d
Cleared Jul 21, 2003
CARDIOVATIONS RETRACTOR
K031847 · GCJ
Ethicon, Inc.
General & Plastic Surgery · 35d
Cleared Jul 17, 2003
UNIT, CAUTERY, TEHRMAL,BATTERY-POWERED
K030158 · GEI
Walsh Medical Devices, Inc.
General & Plastic Surgery · 182d
Cleared Jul 17, 2003
LUMENIS FAMILY OF IPL SYSTEMS AND COMBINATION IPL/ND:YAG SYSTEMS
K030342 · GEX
Lumenis, Ltd.
General & Plastic Surgery · 164d
Cleared Jul 17, 2003
OMNILUX RED
K030426 · GEX
Photo Therapeutics Limited
General & Plastic Surgery · 157d
Cleared Jul 17, 2003
MONOPLUS POLY-P-DIOXANONE MONOFILAMENT ABSORBABLE SURGICAL SUTURE
K031216 · NEW
Aesculap
General & Plastic Surgery · 91d
Cleared Jul 17, 2003
CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM
K031247 · GEI
Medtronic Vascular
General & Plastic Surgery · 90d
Cleared Jul 17, 2003
NATURALASE LP ND:YAG LASER
K031828 · GEN
Focus Medical, LLC
General & Plastic Surgery · 34d
Cleared Jul 17, 2003
RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR AND ACCESSORIES (E.G., RITA...
K031926 · GEI
Rita Medical Systems, Inc.
General & Plastic Surgery · 24d
Cleared Jul 17, 2003
BAYLIS PAIN MANAGEMENT GENERATOR, MODELS PMG-115-TD AND PMG-230-TD
K031950 · GEI
Baylis Medical Co., Inc.
General & Plastic Surgery · 23d