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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
119473–119496 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 11, 1991
CONVERTORS SAFECARE GOWN & DRAPE MATERIAL
K913506 · KKX
Baxter Healthcare Corp
General Hospital · 65d
Cleared Oct 11, 1991
PCP DIRECT RIA KIT (I-125)
K913864 · LCL
Immunalysis Corporation
Toxicology · 45d
Cleared Oct 11, 1991
IL BG3 SYST, MODEL 1420, BLOOD GAS & PH TEST SYST
K913927 · CHL
Instrumentation Laboratory CO
Chemistry · 38d
Cleared Oct 11, 1991
DIFF SAFE
K914129 · JKA
Marshall Levinson
Chemistry · 28d
Cleared Oct 11, 1991
BIOSITE DIAGNOSTICS-TRIAGE PANEL FOR DRUGS ABUSE
K914146 · DKZ
Biosite Incorporated
Toxicology · 25d
Cleared Oct 11, 1991
BARTELS PRIMA SYSTEM ADVANCED SCREENING CARTRIDGE
K914202 · JJQ
Baxter Diagnostics, Inc.
Chemistry · 22d
Cleared Oct 11, 1991
PROCLINIC ONE STEP PREGNANCY TEST
K914253 · JHI
Vanguard Biomedical Corp.
Chemistry · 18d
Cleared Oct 11, 1991
ABBOTT QUICKSTART LDH,#5A31
K914262 · CFJ
Em Diagnostic Systems, Inc.
Chemistry · 18d
Cleared Oct 11, 1991
TARGET(TM)-HOG
K914303 · JHI
V-Tech, Inc.
Chemistry · 16d
Cleared Oct 11, 1991
SIEMENS MODEL LS-I W/INFINITI PROGRAMMABLE OPTION
K914333 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 14d
Cleared Oct 10, 1991
TURBOTRON 20/20
K902920 · LYL
Prestige Manufacturing Snd Bhd
Ophthalmic · 464d
Cleared Oct 10, 1991
BIO-SENSOR 01 EKG ELECTRODE
K911472 · DRX
Bio-Sensor, Inc.
Cardiovascular · 190d
Cleared Oct 10, 1991
MARQUETTE PEDIATRIC DEFIBRILLATION/PACING PADS
K911662 · LDD
Marquette Electronics, Inc.
Cardiovascular · 181d
Cleared Oct 10, 1991
VER-MED A10020 RESTING EKG ELECTRODE
K911687 · DRX
Vermont Medical, Inc.
Cardiovascular · 177d
Cleared Oct 10, 1991
MEDILASE SEMI-RIGID INSTROD SHEATH SERIES AE1000
K912265 · FED
Medical Laser, Inc.
Gastroenterology & Urology · 141d
Cleared Oct 10, 1991
MILITARY RADIOGRAPHIC FLAT TABLE, CAT # T-9130
K912382 · IXQ
Continental X-Ray Corp.
Radiology · 134d
Cleared Oct 10, 1991
FLEX-ELBOW
K912652 · BZA
Vital Signs, Inc.
Anesthesiology · 115d
Cleared Oct 10, 1991
ARTHRO-FLOW IRRIGATION 2 SYSTEM
K913028 · HRX
Davol, Inc.
Orthopedic · 93d
Cleared Oct 10, 1991
PDM-1 DEVICE:CAPD DISINFECTING DEVICE, MODIFIED
K913110 · DRQ
Microwave Medical Systems, Inc.
Cardiovascular · 90d
Cleared Oct 10, 1991
AEROSOL MASKS, 81426, 81476, 81490 & 81492
K913220 · CAF
Specialty Packaging Producs, Inc.
Anesthesiology · 83d
Cleared Oct 10, 1991
VITALMAX 830 SERIES
K913263 · MHX
Pace Tech, Inc.
Cardiovascular · 79d
Cleared Oct 10, 1991
VENTURI OXYGEN MASK
K913275 · BYG
Specialty Packaging Producs, Inc.
Anesthesiology · 79d
Cleared Oct 10, 1991
SCHNEIDER MATCH-35(TM) PERCU TRANS ANGIOPLAS CATH
K913297 · LIT
Schneider Intl., Ltd.
Cardiovascular · 78d
Cleared Oct 10, 1991
MUCOUS SPECIMEN TRAP
K913643 · BYZ
Medical Device Inspection Co., Inc.
General Hospital · 57d