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
78217–78240 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 12, 2001
HYPODERMIC NEEDLE-PRO NEEDLE WITH NEEDLE PROTECTION DEVICE
K011925 · FMI
Sims Portex, Inc.
General Hospital · 22d
Cleared Jul 12, 2001
VARISEED 7.0
K012017 · MUJ
Varian Medical Systems
Radiology · 14d
Cleared Jul 12, 2001
VOXAR VC, MODEL 1.0
K012072 · LLZ
Voxar Limited
Radiology · 10d
Cleared Jul 12, 2001
VORTEX
K012097 · LLZ
Ultravisual Medical Systems
Radiology · 7d
Cleared Jul 12, 2001
PROTON THERAPY SYSTEM
K983024 · LHN
Ion Beam Applications S.A.
Radiology · 1046d
Cleared Jul 11, 2001
MACROPOREPX PEDIATRIC SYSTEM
K002207 · JEY
Macropore Biosurgery, Inc.
Dental · 355d
Cleared Jul 11, 2001
VENOUS HARDSHELL CARDIOTOMY RESEVOIR, MODEL VHK 4201
K003551 · DTN
Jostra AG
Cardiovascular · 236d
Cleared Jul 11, 2001
SCS DT-02 TRANSVERSE CONNECTOR
K003823 · KWP
Ortho Tec, LLC
Orthopedic · 212d
Cleared Jul 11, 2001
SIGN IM NAIL
K011129 · HSB
Sign, Inc.
Orthopedic · 89d
Cleared Jul 11, 2001
TELEPAX
K011173 · LLZ
Imed Systems & Consulting, LLC
Radiology · 85d
Cleared Jul 11, 2001
DEVILBISS 9000 SERIES CPAP, MODEL 9001
K011229 · BZD
Sunrise Medical Hhg, Inc.
Anesthesiology · 79d
Cleared Jul 11, 2001
RECTOSIGHT RS300-04
K011825 · FER
Sightline Technologies , Ltd.
Gastroenterology & Urology · 30d
Cleared Jul 11, 2001
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS...
K011851 · DQA
Masimo Corp.
Anesthesiology · 28d
Cleared Jul 11, 2001
MODIFIED M-IV MAMMOGRAPHY SYSTEM
K011987 · IZH
Lorad, A Hologic Co.
Radiology · 15d
Cleared Jul 10, 2001
POWDER FREE LATEX EXAMINATION GLOVES
K010546 · LYY
Jb Star Sdn Bhd
General Hospital · 137d
Cleared Jul 10, 2001
SYNCHRON SYSTEMS HEMOGLOBIN A1C REAGENT
K010748 · LCP
Beckman Coulter, Inc.
Hematology · 119d
Cleared Jul 10, 2001
OXFORD UNICOMPARTMENTAL KNEE FEMORAL COMPONENT
K011138 · HRY
Biomet, Inc.
Orthopedic · 88d
Cleared Jul 10, 2001
ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-125
K011205 · KXK
Isoaid
Radiology · 82d
Cleared Jul 10, 2001
EAR THERMOMETER, MODELS ST613C AND ST613F
K011254 · FLL
Mesure Technology
General Hospital · 77d
Cleared Jul 10, 2001
POWDER FREE POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES, NON-STERILE W/...
K011293 · LYY
Multisafe Sdn. Bhd.
General Hospital · 71d
Cleared Jul 10, 2001
UROLOGIC
K011311 · OWB
Pck Electronic Industry and Trade Co,...
Radiology · 71d
Cleared Jul 10, 2001
SURGICAL DRAPES
K011422 · KKX
Advance Medical Designs, Inc.
General Hospital · 62d
Cleared Jul 10, 2001
CYMUN-NBR POWDER FREE BLUE NITRILE EXAMINATION GLOVE
K011497 · LZA
Tillotson Healthcare Corp.
General Hospital · 56d
Cleared Jul 10, 2001
LUTE
K011517 · EBF
First Scientific Limited
Dental · 54d