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
77329–77352 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 01, 2002
EXS-63 SMALL EXTREMITY ARRAY COIL
K020036 · MOS
Mri Devices Corp.
Radiology · 28d
Cleared Feb 01, 2002
JB-70 INTRAORAL X-RAY SYSTEM, MODELS 30-A0001/A0002
K020070 · EHD
Progeny, Inc.
Radiology · 23d
Cleared Feb 01, 2002
PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE
K020129 · JIX
Phoenix Diagnostics, Inc.
Chemistry · 18d
Cleared Feb 01, 2002
MODIFICATION TO ISOBAR SPINAL SYSTEM
K020245 · MNH
Scien'Tx USA, Inc.
Orthopedic · 8d
Cleared Jan 31, 2002
HUMPHREY OCT3
K012727 · IYO
Carl Zeiss Ophthalmic Systems, Inc.
Radiology · 169d
Cleared Jan 31, 2002
MATRIX DETACHABLE COILS
K012985 · HCG
Boston Scientific, Target
Neurology · 147d
Cleared Jan 31, 2002
GLOBALCARDIO
K013354 · DSH
Cardiocomm Solutions, Inc.
Cardiovascular · 114d
Cleared Jan 31, 2002
NUCLEOTOMY INTRADISCAL CATHETER
K013622 · GEI
Oratec Interventions, Inc.
General & Plastic Surgery · 87d
Cleared Jan 31, 2002
APEX MEDICAL MINI TENS
K020032 · GZJ
Apex Medical Corp.
Neurology · 27d
Cleared Jan 31, 2002
MODIFICATION TO AUGUSTINE MEDICAL WOUND CARE SYSTEM, MODEL 68XXX
K020077 · MSA
Augustine Medical, Inc.
General & Plastic Surgery · 22d
Cleared Jan 30, 2002
SPIKED WASHER
K011583 · HTN
Synthes (Usa)
Orthopedic · 252d
Cleared Jan 30, 2002
DRG QUICKMIX
K011736 · GXP
Doctor'S Research Group, Inc.
General & Plastic Surgery · 239d
Cleared Jan 30, 2002
BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM
K012184 · KWQ
Blackstone Medical, Inc.
Orthopedic · 202d
Cleared Jan 30, 2002
LIVERPOOL RADIAL HEAD REPLACEMENT DEVICE
K012551 · KWI
Biomet, Inc.
Orthopedic · 176d
Cleared Jan 30, 2002
BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1
K012702 · JWH
Endotec, Inc.
Orthopedic · 169d
Cleared Jan 30, 2002
DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER
K012924 · CAD
Datex-Ohmeda, Inc.
Anesthesiology · 152d
Cleared Jan 30, 2002
MODEL7500 MICROCURRENT TENS DEVICE, MCT-F5, MCT-F50, MCT-F500
K013167 · GZJ
Newcare Products, LLC
Neurology · 131d
Cleared Jan 30, 2002
ASCEND SPINAL FIXATION SYSTEM WITH THE SHADOW SPINAL SYSTEM
K013196 · KWP
Spinal Innovations, LLC
Orthopedic · 127d
Cleared Jan 30, 2002
LTF-240 PLEURAVIDEOSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENTS
K013617 · GCJ
Olympus Optical Co., Ltd.
General & Plastic Surgery · 86d
Cleared Jan 30, 2002
IDENT-A100 INTRAORAL VIDEO CAMERA
K013690 · EIA
Confident Technology, Inc.
Dental · 84d
Cleared Jan 30, 2002
MEDITRON II THESTERTHOSCOPE SYSTEM
K013725 · DQD
Meditron AS
Cardiovascular · 82d
Cleared Jan 30, 2002
COMPAS AS (COMPUTERIZED PULMONARY ANALYSIS SYSTEM)
K013752 · BZG
Morgan Scientific, Inc.
Anesthesiology · 78d
Cleared Jan 30, 2002
SLEEPBITE
K013808 · LRK
Dental Imagineers, LLC
Dental · 76d
Cleared Jan 30, 2002
FINN CHAMBER (R)
K013820 · KXF
Epitest Ltd. OY
General Hospital · 75d