FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
68257–68280 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 01, 2004
OSTEOSORB TACK FIXATION SYSTEM
K030989 · JEY
Noviace Corporation
Orthopedic · 370d
Cleared Apr 01, 2004
STRYKER RF ELECTRODES AND CANNULAE
K032406 · GXI
Stryker Instruments
Neurology · 241d
Cleared Apr 01, 2004
SYNTHES AFS
K032534 · NQW
Synthes Spine
Orthopedic · 230d
Cleared Apr 01, 2004
STRYKER INTERVENTIONAL PAIN RF GENERATOR
K032601 · GXD
Valley Forge Scientific Corp.
Neurology · 220d
Cleared Apr 01, 2004
LUCENTLITE, MODEL IMD 010
K033072 · GEX
Industrial & Medical Design, Inc.
General & Plastic Surgery · 185d
Cleared Apr 01, 2004
ULTRAPRO MESH
K033337 · FTL
Ethicon, Inc.
General & Plastic Surgery · 167d
Cleared Apr 01, 2004
KYPHX HV-R, MODEL C01A
K033801 · NDN
Kyphon, Inc.
Orthopedic · 115d
Cleared Apr 01, 2004
MEDISIL SILICONE SHEETING
K040042 · MIB
Medisil Corporation
General & Plastic Surgery · 80d
Cleared Apr 01, 2004
PALOMAR LUXV HANDPIECE
K040081 · GEX
Palomar Medical Technologies, Inc.
General & Plastic Surgery · 77d
Cleared Apr 01, 2004
RABBIT
K040087 · KNW
Scion International, Inc.
Gastroenterology & Urology · 76d
Cleared Apr 01, 2004
QUIXX POSTERIOR RESTORATIVE
K040144 · EBF
Dentsply International
Dental · 70d
Cleared Apr 01, 2004
STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230)
K040240 · GEI
Stellartech Research Corp.
General & Plastic Surgery · 58d
Cleared Apr 01, 2004
STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
K040369 · DZJ
Stryker Instruments
Dental · 48d
Cleared Apr 01, 2004
NUVASIVE NEUROVISION JJB SYSTEM
K040543 · ETN
Nuvasive, Inc.
Ear, Nose, Throat · 30d
Cleared Apr 01, 2004
MODIFICATION TO ACCULEAF
K040553 · IXI
Direx Systems Corp.
Radiology · 30d
Cleared Apr 01, 2004
CLICK-ON
K040633 · FPA
Unomedical A/S
General Hospital · 22d
Cleared Mar 31, 2004
BIOCRYL RAPIDE INTERFERENCE SCREW
K032717 · HWC
Mitek Worldwide
Orthopedic · 211d
Cleared Mar 31, 2004
INION GTR BIODEGRADABLE MEMBRANE SYSTEM
K033074 · NPK
Inion , Ltd.
Dental · 184d
Cleared Mar 31, 2004
OTOFLEX 100 TYE 1012
K033645 · ETY
Gn Otometrics A/S
Ear, Nose, Throat · 132d
Cleared Mar 31, 2004
BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM
K033702 · MQP
Blackstone Medical, Inc.
Orthopedic · 127d
Cleared Mar 31, 2004
MERLIN SPINE SYSTEM
K033901 · NKB
Depuy Spine, Inc.
Orthopedic · 105d
Cleared Mar 31, 2004
CORLINK AUTOMATED ANASTOMOTIC SYSTEM
K033979 · FZP
By-Pass Makafim , Ltd.
General & Plastic Surgery · 99d
Cleared Mar 31, 2004
AESCULAP ABSORBABLE CRANIOFIX
K040080 · GXR
Aesculap, Inc.
Neurology · 76d
Cleared Mar 31, 2004
SYNTHES EXTERNAL MIDFACE DISTRACTOR
K040083 · MQN
Synthes (Usa)
Dental · 76d