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
72025–72048 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 26, 2003
DENTAL PROTECTOR
K024261 · MQC
Dental Concepts, LLC
Dental · 93d
Cleared Mar 26, 2003
CLEARFIL SILANE KIT
K024356 · KLE
Kuraray Medical, Inc.
Dental · 86d
Cleared Mar 26, 2003
MHS 7000
K030018 · LHQ
Micro Health Systems, Inc.
Radiology · 83d
Cleared Mar 26, 2003
MODIFICATION TO EXPORT ASPIRATION CATHETER
K030201 · NFA
Medtronic Vascular
Cardiovascular · 64d
Cleared Mar 26, 2003
GLOVETEX LATEX EXAMINATION GLOVES, POWDERED, BLUE, NON STERILE
K030273 · LYY
Pt. Wrp Buana Multicorpora
General Hospital · 58d
Cleared Mar 26, 2003
PORTA IMPLANT
K030312 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 55d
Cleared Mar 26, 2003
SPI ELEMENT DENTAL IMPLANT O 3.5 MM
K030689 · DZE
Thommen Medical AG
Dental · 21d
Cleared Mar 26, 2003
CLINIQA LIQUID QC TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEVEL 3, AND TRI LEVEL
K030705 · JJY
Cliniqa Corporation
Chemistry · 20d
Cleared Mar 26, 2003
DIAGNOSTIC ULTRASOUND BLADDERMASS BVM 6500 ULTRASOUND SYSTEM
K030763 · IYO
Diagnostic Ultrasound Corp.
Radiology · 15d
Cleared Mar 26, 2003
AMSCO CENTURY STEAM STERILIZER
K030789 · FLE
STERIS Corporation
General Hospital · 14d
Cleared Mar 25, 2003
LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100
K020271 · KFM
Levitronix, LLC
Cardiovascular · 421d
Cleared Mar 25, 2003
STERILIZATION CASES AND TRAYS
K023658 · FRG
Carr Metal Products, Inc.
General Hospital · 145d
Cleared Mar 25, 2003
VINYL EXAMINATION GLOVES, PRE-POWDERED WITH VITAMIN E
K023753 · LYZ
Arista Latindo Industrial Ltd. P.T
General Hospital · 137d
Cleared Mar 25, 2003
VINYL EXAMINATION GLOVES, POWDER-FREE WITH VITAMIN E
K023754 · LYZ
Arista Latindo Industrial Ltd. P.T
General Hospital · 139d
Cleared Mar 25, 2003
REACTIVE SKIN DECONTAMINATION LOTION
K023969 · MAC
Dept. of the Army
General Hospital · 116d
Cleared Mar 25, 2003
LATEX CONDOM AND LATEX CONDOM LUBRICATED WITH NONOXYNOL-9
K024324 · HIS
Global Protection Corp.
Obstetrics & Gynecology · 89d
Cleared Mar 25, 2003
SETPOINT ENDOVASCULAR TEMPERATURE PROBE
K024327 · DQY
Radiant Medical
Cardiovascular · 89d
Cleared Mar 25, 2003
20.1 MONOCHROME LCD MONITOR, RADIFORCE G21
K024358 · LLZ
Eizo Nanao Corporation
Radiology · 85d
Cleared Mar 25, 2003
LATEX EXAMINATION GLOVES POWDER FREE WITH NEOPRENE LINED, SIZES XSMALL,...
K030134 · LYY
Pt.Shamrock Manufacturing Corp.
General Hospital · 70d
Cleared Mar 25, 2003
POWDER FREE NITRILE EXAMINATION GLOVES (NATURAL, BLUE,PURPLE)
K030284 · LZA
Pt. Smartglove Indonesia
General Hospital · 57d
Cleared Mar 25, 2003
MODEL 1300GE-64: PEDIATRIC POSITIONER
K030317 · MOS
Midwest Rf, LLC
Radiology · 54d
Cleared Mar 25, 2003
PROVEN MODULAR TIBIAL TRAY
K030577 · JWH
Stelkast Company
Orthopedic · 29d
Cleared Mar 25, 2003
VERTE-STACK SPINAL SYSTEM
K030601 · MQP
Medtronic Sofamor Danek
Orthopedic · 28d
Cleared Mar 25, 2003
BOSTON SCIENTIFIC EXPRESS BILIARY LD UNMOUNTED STENT
K030645 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 25d