Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
73153–73176 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Mar 25, 2003
STANDARD THERMOMETER
K030658 · FLL
Global Treasure Industries , Ltd.
General Hospital · 22d
Cleared Mar 25, 2003
BONE WIRE
K030665 · HTY
Stork Instrumente GmbH
Orthopedic · 22d
Cleared Mar 25, 2003
MULTICARE PLATINUM SYSTEM AND ACCESSORIES
K030666 · IZH
Lorad, A Hologic Co.
Radiology · 22d
Cleared Mar 24, 2003
SYNTHES USS, CLICK'X, USS VAS, DUAL-OPENING USS AND SMALL STATURE USS
K022949 · MNI
Synthes (Usa)
Orthopedic · 200d
Cleared Mar 24, 2003
MODIFICATION TO PLEXOLONG SETS
K023218 · BSP
Pajunk GmbH
Anesthesiology · 179d
Cleared Mar 24, 2003
LSI ENDOSCOPIC EXTERNAL ACCESSORY CHANNEL AND ACCESSORIES PRODUCT
K024301 · ODC
Lsi Solutions
Gastroenterology & Urology · 90d
Cleared Mar 24, 2003
NMA 1052 CONSOLE SYSTEM WITH NMA 100 LASER ACCESSORY
K024310 · NHN
Medx Electronics, Inc.
Physical Medicine · 90d