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
37009–37032 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 22, 2014
EQUALIZER OCCLUSION BALLOON CATHETER
K140273 · MJN
Boston Scientific Corp
Cardiovascular · 169d
Cleared Jul 22, 2014
BIO-CONNEKT WOUND MATRIX
K140456 · KGN
MLM Biologics, Inc.
General & Plastic Surgery · 148d
Cleared Jul 22, 2014
VIS-U-ALL LOW TEMPERATURE STERILIZATION POUCH/TUBING
K140487 · FRG
STERIS Corporation
General Hospital · 145d
Cleared Jul 22, 2014
VELOXTM INTERBODY FUSION SYSTEM
K140864 · ODP
U&I Corp.
Orthopedic · 110d
Cleared Jul 22, 2014
VIEW PLATING SYSTEM,REDUCE FRACTURE PLATING SYSTEM,BONE SCREW
K140876 · HRS
Icon Orthopedic Concepts, LLC Dba...
Orthopedic · 106d
Cleared Jul 22, 2014
OARTRAC SYSTEM
K141154 · NZT
Radiadyne
Radiology · 78d
Cleared Jul 22, 2014
SHASER SKIN BEAUTY INTENSE PULSED LIGHT SYSTEM FAMILY
K141583 · ONF
Shaser, Inc.
General & Plastic Surgery · 39d
Cleared Jul 22, 2014
CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE
K141652 · KPS
Cedars-Sinai Medical Center
Radiology · 32d
Cleared Jul 22, 2014
EEVA DISH (WITH 12 MICROWELLS)
K141663 · MQK
Auxogyn, Inc.
Obstetrics & Gynecology · 29d
Cleared Jul 22, 2014
VARIAX ELBOW PLATING SYSTEM
K141677 · HRS
Stryker Trauma AG
Orthopedic · 29d
Cleared Jul 22, 2014
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
K141678 · NTE
Abbott Vascular
Cardiovascular · 29d
Cleared Jul 21, 2014
BABYMEG BIOMAGNETOMETER SYSTEM
K133419 · OLY
Tristan Technologies, Inc.
Neurology · 256d
Cleared Jul 21, 2014
THREADER MONORAIL MICRO-DILATATION CATHETER, THREADER OVER-THE-WIRE...
K134031 · LOX
Boston Scientific Corporation
Cardiovascular · 202d
Cleared Jul 21, 2014
CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 1, CAPTIVATOR EMR...
K140726 · FDI
Boston Scientific Corp
Gastroenterology & Urology · 119d
Cleared Jul 21, 2014
BIOSURE HEALICOIL PK INTERFERENCE SCREW
K140879 · MBI
Smith & Nephew, Inc.
Orthopedic · 105d
Cleared Jul 21, 2014
EXCIA TOTAL HIP SYSTEM
K140915 · LZO
Aesculap Implant Systems, LLC
Orthopedic · 102d
Cleared Jul 21, 2014
AZUL PERSONAL LUBRICANT
K141034 · NUC
Church & Dwight Co., Inc.
Obstetrics & Gynecology · 90d
Cleared Jul 18, 2014
MEDYSSEY ANTERIOR CERVICAL FUSION CAGE
K132732 · ODP
Medyssey USA, Inc.
Orthopedic · 318d
Cleared Jul 18, 2014
PJUR ORIGINAL, PJUR WOMAN, PJUR MAN EXTREME GLIDE
K133233 · NUC
Pjur Group Luxembourg S.A.
Obstetrics & Gynecology · 270d
Cleared Jul 18, 2014
ZIMMER ZFX TITANIUM BASE ABUTMENT FOR TAPERED SCREWVENT IMPLANT SYSTEM
K133551 · NHA
Zimmer Dental, Inc.
Dental · 241d
Cleared Jul 18, 2014
POWDER FREE GREEN, BLUE AND BROWN POLYCHLOROPRENE EXAMINATION GLOVES
K133699 · LZA
Pt. Smartglove Indonesia
General Hospital · 227d
Cleared Jul 18, 2014
ALMA DIODE TABLETOP LASER
K140005 · GEX
Alma Lasers , Ltd.
General & Plastic Surgery · 197d
Cleared Jul 18, 2014
AEQUALIS(TM) ASCENT(TM) FLEX SHOULDER SYSTEM
K140082 · PHX
Tornier S.A.S.
Orthopedic · 186d
Cleared Jul 18, 2014
E-SHIELD MULTI-PAIRED SUBDERMAL NEEDLE ELECTRODES
K140200 · GXZ
Neuroinvent, Inc.
Neurology · 172d