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
69961–69984 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 28, 2003
MEDTRONIC MINIMED PARADIGM COUNTACH INFUSION SET, MODEL MMT 310
K032484 · FPA
Medtronic Minimed
General Hospital · 77d
Cleared Oct 28, 2003
MEDTRONIC MINIMED COUNTACH INFUSION SET, MODEL 313
K032485 · FPA
Medtronic Minimed
General Hospital · 77d
Cleared Oct 28, 2003
KAVO EVEREST ZH-BLANK
K033221 · EIH
Kavo America Corporation
Dental · 25d
Cleared Oct 28, 2003
BUTLER NUCARE ROOT CONDITIONER WITH NOVAMIN
K033295 · LBH
Novamin Technology, Inc.
Dental · 14d
Cleared Oct 27, 2003
PERFADEX SOLUTION FOR LUNG PRESERVATION
K022730 · MSB
Vitrolife AB
Gastroenterology & Urology · 437d
Cleared Oct 27, 2003
EMBLA N7000
K024322 · MNR
Medcare Flaga
Anesthesiology · 305d
Cleared Oct 27, 2003
FLUID SAMPLE RETRIEVAL SYSTEM
K030394 · JKA
Biomed Personal Metabolic and...
Chemistry · 264d
Cleared Oct 27, 2003
SWISS MASTER LIGHT
K032099 · EBZ
(Ems Sa) Electro Medical Systems
Dental · 111d
Cleared Oct 27, 2003
SMARTMONITOR 2 PROFESSIONAL SERIES (PS)
K032403 · NPF
Respironics, Inc.
Anesthesiology · 84d
Cleared Oct 27, 2003
VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER
K033108 · EWO
Vivosonic, Inc.
Ear, Nose, Throat · 27d
Cleared Oct 27, 2003
CENTRA VIEW DEVICE LINK SYSTEM
K033283 · MWI
Icu Datasystems, Inc.
Cardiovascular · 13d
Cleared Oct 24, 2003
AVITA TS8/TS9 SERIES IR EAR/FOREHEAD THERMOMETER
K031503 · FLL
Avita Corporation
General Hospital · 164d
Cleared Oct 24, 2003
SAFESKIN* BLUE ZONE POWDER-FREE VINYL EXAM GLOVE
K031750 · LYZ
Kimberly-Clark Corp.
General Hospital · 141d
Cleared Oct 24, 2003
BRAUN THERMOSCAN PRO 4000 SERIES (PROFESSIONAL USE ENVIRONMENT)
K031928 · FLL
Braun GmbH
General Hospital · 123d
Cleared Oct 24, 2003
NUVASIVE NEUROVISION JJB SYSTEM
K032083 · ETN
Nuvasive, Inc.
Ear, Nose, Throat · 109d
Cleared Oct 24, 2003
ADEPT 1064/532/755 LASER
K032218 · GEX
Adept Medical Concepts
General & Plastic Surgery · 95d
Cleared Oct 24, 2003
ADEPT 1064/532 LASER
K032220 · GEX
Adept Medical Concepts
General & Plastic Surgery · 95d
Cleared Oct 24, 2003
ADEPT 1064/755 LASER
K032221 · GEX
Adept Medical Concepts
General & Plastic Surgery · 95d
Cleared Oct 24, 2003
CAP BONE SUBSTITUTE MATERIAL
K032307 · GXP
Etex Corp.
Neurology · 91d
Cleared Oct 24, 2003
CONVERGE RETI-LOCK MULTI-HOLE REINFORCEMENT CUP
K032348 · LZO
Centerpulse Orthopedics, Inc.
Orthopedic · 86d
Cleared Oct 24, 2003
QUANTEX D-DIMER
K032419 · DAP
Instrumentation Laboratory CO
Hematology · 80d
Cleared Oct 24, 2003
NASAL JACKS MASK
K032433 · BZD
Resmed, Ltd.
Anesthesiology · 79d
Cleared Oct 24, 2003
STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM
K032482 · GKR
Stanbio Laboratory
Hematology · 73d
Cleared Oct 24, 2003
INNOVATECH STRAIGHT LASER PROBE, MODEL 420-10
K032703 · GEX
Innovatech Surgical, Inc.
General & Plastic Surgery · 52d