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
69217–69240 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 14, 2004
DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR, MODEL DFP8000D
K041027 · IZI
Toshibamedical Systems Corporation
Radiology · 23d
Cleared May 14, 2004
CROWN DELTA HYDROPHILIC IMPRESSION MATERIAL
K041028 · ELW
Crown Delta Corp.
Dental · 23d
Cleared May 14, 2004
BD VACUTAINER TRACE ELEMENT SERUM PLUS TUBE AND BD VACUTAINER TRACE ELEMENT...
K041071 · JKA
Becton, Dickinson & CO
Chemistry · 18d
Cleared May 14, 2004
NEWTOM 3G QR-DVT 9000
K041137 · OAS
Aperio Services, LLC
Radiology · 14d
Cleared May 14, 2004
MODIFICATION TO E-SCAN XQ MRI SYSTEM
K041145 · MOS
Esaote, S.P.A.
Radiology · 11d
Cleared May 14, 2004
TORSO ARRAY COIL, MODEL 558GE-64
K041185 · MOS
Igc-Medical Advances, Inc.
Radiology · 8d
Cleared May 13, 2004
CLEAR-THERM MICRO HME, MODEL 1441
K032322 · CAH
Intersurgical, Inc.
General Hospital · 290d
Cleared May 13, 2004
INOGEN ONE OXYGEN CONCENTRATOR
K032818 · CAW
Inogen, Inc.
Anesthesiology · 246d
Cleared May 13, 2004
LAPAROSCOPIC INSTRUMENT, ELECTRODE AND CABLE
K032965 · GEI
Modern Medical Equipment Mfg., Ltd.
General & Plastic Surgery · 233d
Cleared May 13, 2004
SUCTION COAGULATOR
K033003 · GEI
Modern Medical Equipment Mfg., Ltd.
General & Plastic Surgery · 231d
Cleared May 13, 2004
AIR SAFETY HEPA AND NON-HEPA FILTERS
K033008 · CAH
Air Safety, Ltd.
General Hospital · 230d
Cleared May 13, 2004
INOGEN SATELLITE CONSERVER
K033197 · NFB
Medical Electronic Devices, Inc.
Anesthesiology · 224d
Cleared May 13, 2004
POLARIS 2004 CAPNOGRAPH
K040011 · CCK
Oridion , Ltd.
Anesthesiology · 129d
Cleared May 13, 2004
KLS MARTIN HAND PLATING SYSTEM
K040598 · HRS
KLS-Martin L.P.
Orthopedic · 66d
Cleared May 13, 2004
VARELISA SSDNA ANTIBODIES, MODEL 14896
K040811 · LRM
Pharmacia Deutschland GmbH
Immunology · 45d
Cleared May 13, 2004
COLOR LCD MONITOR, MODEL RADIFORCE R12
K040982 · LLZ
Eizo Nanao Corporation
Radiology · 28d
Cleared May 13, 2004
MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS
K040990 · NEU
Walter Lorenz Surgical, Inc.
General & Plastic Surgery · 27d
Cleared May 13, 2004
BIOKNOTLESS RC ANCHOR
K041064 · JDR
Depuy Mitek
Orthopedic · 20d
Cleared May 13, 2004
COOL TEMP NATURAL
K041098 · EBG
Coltene AG
Dental · 16d
Cleared May 13, 2004
APPLE MEDICAL OB MOBIUS ELASTIC RETRACTOR
K041131 · GCJ
Apple Medical Corp.
General & Plastic Surgery · 13d
Cleared May 12, 2004
VERICOR
K031327 · DXN
Cvp Diagnostics, Inc.
Cardiovascular · 383d
Cleared May 12, 2004
ALVEOLUS INC. TB-STS TRACHEOBRONCHIAL STENT SYSTEM
K033990 · JCT
Alveolus, Inc.
General & Plastic Surgery · 141d
Cleared May 12, 2004
REFLEXION CANNULATOR STEERABLE ELECTROPHYSIOLOGY CATHETER WITH LUMEN, MODEL...
K040165 · DRA
St Jude Medical
Cardiovascular · 107d
Cleared May 12, 2004
IMPAX OT3000 ORTHOPEDIC WORKSTATION
K040344 · LLZ
Agfa Corp.
Radiology · 90d