FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
72553–72576 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Mar 24, 2003
AESULAP KOPITNIK AVM MICROCLIPS AND APPLIER
K024349 · HCH
Aesculap, Inc.
Neurology · 84d
Cleared Mar 24, 2003
XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT
K030194 · KNS
The Olympus Optical Co.
Gastroenterology & Urology · 62d
Cleared Mar 24, 2003
BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT
K030238 · DBM
The Binding Site, Ltd.
Immunology · 60d
Cleared Mar 24, 2003
MODIFICATION TO VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTRILLED...
K030567 · JCT
Vascular Architects, Inc.
General & Plastic Surgery · 28d
Cleared Mar 24, 2003
MODIFICATION TO SUZANNE PORTABLE POLYSOMNOGRAPH SYSTEM
K030611 · MNR
Nellcor Puritan Bennett (Melville) ,...
Anesthesiology · 26d
Cleared Mar 21, 2003
IQTEQ SPIROMETER
K020102 · BZG
Iqteq Development
Anesthesiology · 434d
Cleared Mar 21, 2003
STIMUPLEX-DIG-RC NERVE STIMULATOR
K021033 · BXN
B.Braun Medical, Inc.
Anesthesiology · 357d
Cleared Mar 21, 2003
ENDOSCOPE SET FOR MAGNETIC RESONANCE (MR), MODELS 8767.412, 8767.121 & 8767.452
K022198 · GWG
Richard Wolf Medical Instruments Corp.
Neurology · 259d