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
38473–38496 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 06, 2014
POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
K131341 · LYZ
Shijiazhuang Winful Plastic Co., Ltd.
General Hospital · 273d
Cleared Feb 06, 2014
DUAL ENERGY SYSTEM PACKAGE
K132813 · JAK
Toshibamedical Systems Corporation
Radiology · 150d
Cleared Feb 06, 2014
CARESTREAM VUE PACS VERSION 11.4 CARESTREAM VUE MOTION APPLICATION
K132824 · LLZ
Carestream Health, Inc.
Radiology · 150d
Cleared Feb 06, 2014
FUSE 1C COLONOSCOPY SYSTEM
K132839 · FDF
Endochoice, Inc.
Gastroenterology & Urology · 149d
Cleared Feb 06, 2014
AIRSTRIP REMOTE PATIENT MONITORING
K133394 · MWI
Airstrip Technologies, LP
Cardiovascular · 93d
Cleared Feb 06, 2014
VDRIVE WITH V-SONO
K133396 · DQX
Stereotaxis, Inc.
Cardiovascular · 92d
Cleared Feb 06, 2014
STAPIX SUPERELASTIC IMPLANT BONE STAPLES
K133523 · JDR
Instratek, Inc.
Orthopedic · 83d
Cleared Feb 06, 2014
NUVANT MCT SYSTEM
K133701 · QYX
Corventis, Inc.
Cardiovascular · 65d
Cleared Feb 06, 2014
APTUS HELI-FX GUIDE - 22CM DEFLECTABLE LENGTH
K140036 · OTD
Aptus Endosystems, Inc.
Cardiovascular · 30d
Cleared Feb 05, 2014
SONILASE LIGHT THERAPY DEVICE
K132613 · OHS
Biorenew Labs, LLC
General & Plastic Surgery · 168d
Cleared Feb 05, 2014
VALIDATE FERRITIN CALIBRATION VERIFICATION/ LINEARITY TEST KIT
K133550 · JJX
Maine Standards Company, LLC
Chemistry · 78d
Cleared Feb 05, 2014
ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAY
K133601 · CEW
Siemens Healthcare Diagnostics, Inc.
Chemistry · 72d
Cleared Feb 05, 2014
RT016 INSPIRATORY FILTER
K133666 · CAH
Fisher &Paykel Healthcare , Ltd.
General Hospital · 68d
Cleared Feb 05, 2014
SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)
K133867 · FPA
Terumo Europe N.V.
General Hospital · 47d
Cleared Feb 05, 2014
CARDIOSOLUTIONS DEXTERITY STEERABLE INTRODUCER
K140015 · DYB
Cardiosolutions, Inc.
Cardiovascular · 34d
Cleared Feb 04, 2014
BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, BEDSIDE RESPIRATORY PATIENT...
K130320 · DQA
Covidien
Anesthesiology · 361d
Cleared Feb 04, 2014
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K130582 · LYZ
Heze City Green Food Co., Ltd.
General Hospital · 336d
Cleared Feb 04, 2014
LZI ORAL FLUID AMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS
K131653 · DKZ
Lin-Zhi International, Inc.
Toxicology · 244d
Cleared Feb 04, 2014
DUTECK(MICHEALTH)DIGITAL CLINICAL THERMOMETER
K132140 · FLL
Duteck Industrial Co., Ltd.
General Hospital · 208d
Cleared Feb 04, 2014
GYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CATHETER
K132383 · LJE
Gyrus Acmi, Inc.
Gastroenterology & Urology · 188d
Cleared Feb 04, 2014
STREAMLINE EXPRESS
K132602 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 168d
Cleared Feb 04, 2014
SMITH & NEPHEW VARIABLE-ANGLE LOCKING MINI-FRAGMENT PLATING SYSTEM
K132886 · HRS
Smith & Nephew, Inc.
Orthopedic · 141d
Cleared Feb 04, 2014
ZIMMER(R) PERSONA THE PERSONALIZED KEE SYSTEM 14X +30MM TAPERED STEM EXTENSION
K133737 · JWH
Zimmer, Inc.
Orthopedic · 57d
Cleared Feb 04, 2014
GFS II STANDARD, GFS II LARGE, GFS MIMI
K133757 · MBI
Parcus Medical, LLC
Orthopedic · 55d