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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
148513–148536 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 19, 1985
ORTHOTRON MUSCLE STIMULATOR MK II DC
K851037 · IPF
Hodgkinson & Corby , Ltd.
Physical Medicine · 97d
Cleared Jun 19, 1985
MODEL BION 1/TYPE 1084T CAR IONIZER
K851094 · FRF
Medicor USA , Ltd.
General Hospital · 92d
Cleared Jun 19, 1985
TERRAN BIOMECHANICAL ANALYSIS SYSTEM
K851133 · LDK
Terran Biomedical Instruments
Physical Medicine · 90d
Cleared Jun 19, 1985
TELEFLEX MEDICAL INTRODUCER NEEDLE
K851140 · DWS
Teleflexmedical, Inc.
Cardiovascular · 90d
Cleared Jun 19, 1985
COBE GAS FILTER
K851289 · KRI
Cobe Laboratories, Inc.
Cardiovascular · 79d
Cleared Jun 19, 1985
CARNATION - OXYGEN MASK
K851466 · BYG
Dadsun Corp., Ltd.
Anesthesiology · 69d
Cleared Jun 19, 1985
MODIFICATIONS TO ACS CORONARY GUIDING CATHETER W/T
K851574 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 63d
Cleared Jun 19, 1985
CENTRIMED SYSTEM 1 W/SYSTEM 1 ADAPTER
K851613 · KFM
Centrimed Corp.
Cardiovascular · 61d
Cleared Jun 19, 1985
CENTRIMED SYSTEM 1 W/24 VOLT BATTERY POWER SUPPLY
K851614 · DTQ
Centrimed Corp.
Cardiovascular · 61d
Cleared Jun 19, 1985
CENTRIMED SYSTEM 1 W/MANUAL PUMP DRIVE
K851615 · DTQ
Centrimed Corp.
Cardiovascular · 61d
Cleared Jun 19, 1985
BIO MEDICUS BIO PUMP MODEL BP-90
K851855 · KFM
Bio Medicus, Inc.
Cardiovascular · 54d
Cleared Jun 19, 1985
MEDTRONIC 5064
K851890 · DTD
Medtronic Vascular
Cardiovascular · 50d
Cleared Jun 19, 1985
MANAN PTC BIOPSY TRAYS
K852104
Manan Manufacturing Co., Inc.
Gastroenterology & Urology · 35d
Cleared Jun 19, 1985
WHOLEY HI-TORQUE GUIDE WIRES
K852123 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 35d
Cleared Jun 18, 1985
CORDIS MULTICOR S 330A & 331A CARDIAC PACEMAKERS
K844360 · DXY
Cordis Corp.
Cardiovascular · 217d
Cleared Jun 18, 1985
LASERSCOPE OMNIPLUS PHOTOSURGICAL SYS ND:YAG
K850018 · GEX
Laserscope
General & Plastic Surgery · 167d
Cleared Jun 18, 1985
SOF. CARE CUSHION & SOF-CARE CUSHION COVER
K851027 · KIC
Gaymar Industries, Inc.
Physical Medicine · 98d
Cleared Jun 18, 1985
VARIABLE NEBULIZER HEATER
K851074 · CAF
Travenol Laboratories, S.A.
Anesthesiology · 92d
Cleared Jun 18, 1985
LODE MODEL CORIVAL ERGOMETER
K851097 · ISD
Lode Corp.
Physical Medicine · 91d
Cleared Jun 18, 1985
TRANSCUTANEOUS ELECTRICAL NERVE STIMULA-ELECTORDE
K851175 · GXY
Medical Devices, Inc.
Neurology · 85d
Cleared Jun 18, 1985
T-HANDLE ADAPTER, U-HANDLE & L HANDLER ADAPTER
K851215 · CAM
Penox Technologies, Inc.
Anesthesiology · 84d
Cleared Jun 18, 1985
PENOX DUAL FEED MANIFOLD
K851216 · CAM
Penox Technologies, Inc.
Anesthesiology · 84d
Cleared Jun 18, 1985
PENOX DUAL FLOW MINIFOLD
K851217 · CAM
Penox Technologies, Inc.
Anesthesiology · 84d
Cleared Jun 18, 1985
FILL HOSE SAFETY ADAPTER
K851219 · CAM
Penox Technologies, Inc.
Anesthesiology · 84d