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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
38953–38976 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 11, 2013
SMITH & NEPHEW PATIENT MATCHED CUTTING BLOCKS
K130708 · JWH
Smith & Nephew, Inc.
Orthopedic · 271d
Cleared Dec 11, 2013
KRONNER SIDE-KICK UTERINE MANIPULATOR HOLDER
K130758 · LKF
Kronner Prototypes, Inc.
Obstetrics & Gynecology · 266d
Cleared Dec 11, 2013
WOUND MEASURING & MONITORING DEVICE
K131596 · FXN
Woundvision, LLC
General & Plastic Surgery · 191d
Cleared Dec 11, 2013
ME
K131649 · ONF
Syneron Beauty , Ltd.
General & Plastic Surgery · 189d
Cleared Dec 11, 2013
ULTHERA SYSTEM
K132028 · OHV
Ulthera, Inc.
General & Plastic Surgery · 163d
Cleared Dec 11, 2013
SIDEXIS 4
K132773 · LLZ
Sirona Dental Systems GmbH
Radiology · 97d
Cleared Dec 11, 2013
VANGUARD XP KNEE SYSTEM
K132873 · MBH
Biomet, Inc.
Orthopedic · 89d
Cleared Dec 11, 2013
CLYDESDALE SPINAL SYSTEM
K132897 · MAX
Medtronic Sofamor Danek, Inc.
Orthopedic · 86d
Cleared Dec 11, 2013
CERTEX OCT SPINAL IMPLANT SYSTEM
K133094 · KWP
X-Spine Systems, Inc.
Orthopedic · 72d
Cleared Dec 11, 2013
ERBE ESU MODEL VIO DV WITH ACCESSORIES
K133180 · GEI
Erbe USA, Inc.
General & Plastic Surgery · 55d
Cleared Dec 11, 2013
THD N-ANO ANOSCOPE
K133687 · FER
Thd Spa
Gastroenterology & Urology · 9d
Cleared Dec 10, 2013
TG-BODY MI&BODY S-TRAINER
K122393 · NGX
Miga Medical Co., Ltd.
Physical Medicine · 490d
Cleared Dec 10, 2013
CPR RSQ ASSIST
K123248 · LIX
Avantech, Inc.
Cardiovascular · 419d
Cleared Dec 10, 2013
CANARY BREATHING SYSTEM
K131586 · HCC
Palo Alto Health Sciences, Inc.
Neurology · 193d
Cleared Dec 10, 2013
RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM
K133039 · NPJ
Mako Surgical Corporation
Orthopedic · 75d
Cleared Dec 10, 2013
BIOSIGN FLU A + B, STATUS FLU A & B
K133474 · PSZ
Princeton BioMeditech Corp.
Microbiology · 28d
Cleared Dec 09, 2013
CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0
K130394 · MEA
Smiths Medical Asd, Inc.
General Hospital · 297d
Cleared Dec 09, 2013
MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636,...
K130861 · MXZ
Dako North America, Inc.
Pathology · 256d
Cleared Dec 09, 2013
SYNGO.PLAZA VB10A
K132532 · LLZ
Siemens AG Healthcare
Radiology · 119d
Cleared Dec 09, 2013
PONTO PLUS AND PONTO PLUS POWER
K132775 · LXB
Oticon Medical AB
Ear, Nose, Throat · 95d
Cleared Dec 09, 2013
EXOSHAPE DUO SOFT TISSUE FASTENER
K132783 · MBI
MedShape, Inc.
Orthopedic · 94d
Cleared Dec 09, 2013
VENT-OS SINUS DILATION SYSTEM
K133016 · LRC
Sinusys Corporation
Ear, Nose, Throat · 75d
Cleared Dec 09, 2013
K7 LUMBAR SPACERS
K133126 · MAX
K7, LLC
Orthopedic · 70d
Cleared Dec 09, 2013
PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
K133289 · HSB
Ellipse Technologies, Inc.
Orthopedic · 45d