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
67489–67512 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 18, 2004
METRICATH SYSTEM
K042685 · DQO
Angiometrx, Inc.
Cardiovascular · 50d
Cleared Nov 18, 2004
ADVANCED LUNG ANALYSIS II
K042694 · OEB
GE Medical Systems
Radiology · 49d
Cleared Nov 18, 2004
BEST MODEL # 81-01 SERIES IR-192 SOURCES
K042786 · KXK
Best Medical International, Inc.
Radiology · 43d
Cleared Nov 18, 2004
URS LP DIGITAL, MILLENNIUM, RADPRO
K042876 · KPR
Sedecal., Sa.
Radiology · 31d
Cleared Nov 18, 2004
PMD-2000 INTERFERENTIAL STIMULATOR
K042881 · IPF
Phoenix Medical Devices, LLC
Physical Medicine · 30d
Cleared Nov 18, 2004
CD HORIZON SPINAL SYSTEM
K042886 · NKB
Medtronic Sofamor Danek
Orthopedic · 30d
Cleared Nov 18, 2004
SEDECAL MOBILE X-RAY UNITS WITH DIGITAL DETECTOR
K043002 · IZL
Sedecal., Sa.
Radiology · 17d
Cleared Nov 18, 2004
PROCERA IMPLANT BRIDGE, MODELS 15-1001, 15-1002, 15-1051, 15-1052
K043042 · NHA
Nobel Biocare AB
Dental · 14d
Cleared Nov 18, 2004
PLAQUEVIEW SOFTWARE, MODEL CSPV-0001A
K043111 · JAK
Toshiba America Medical Systems, In.C
Radiology · 8d
Cleared Nov 17, 2004
SMOKE EVACUATION ATTACHEMENT
K033095 · GEI
Modern Medical Equipment Mfg., Ltd.
General & Plastic Surgery · 415d
Cleared Nov 17, 2004
PULSED LIGHT THERAPY SYSTEM, MODEL PRIMA
K041323 · GEX
New Star Lasers, Inc.
General & Plastic Surgery · 183d
Cleared Nov 17, 2004
MINIMESH POLYPROPYLENE MESH
K041632 · OTO
Mpathy Medical Devices, Ltd.
Obstetrics & Gynecology · 154d
Cleared Nov 17, 2004
OPTION-VM URINARY CATHETER/ADPATER, MODELS MV39016, MVA39016
K041983 · EZL
Opticon Medical
Gastroenterology & Urology · 117d
Cleared Nov 17, 2004
ALUMINA HEAD
K042035 · LZO
Fournitures Hospitalieres Industrie
Orthopedic · 111d
Cleared Nov 17, 2004
FAMILY OF CRYSTAL 20 MONITORS MODEL #CS20-600,900,1300,1400,2400 & 120
K042039 · OLV
Cleveland Medical Devices, Inc.
Neurology · 111d
Cleared Nov 17, 2004
IR HEAT LAMP SYSTEMS: ICL 15 HFPL SYSTEM, ICL 60 PLUS HFPL SYSTEM (MODELS 40,...
K042256 · ILY
Usa Laser Biotech, Inc.
Physical Medicine · 89d
Cleared Nov 17, 2004
SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT (SEPS-CA), (SEPS-CAL),...
K042359 · JXG
Medical Designs, LLC
Neurology · 78d
Cleared Nov 17, 2004
SYNCHRON LX SYSTEMS HEMOGLOBIN A1C2 (HBA1C2) REAGENT
K042459 · LCP
Beckman Coulter, Inc.
Chemistry · 68d
Cleared Nov 17, 2004
IVENT 201 PORTABLE VENTILATOR
K042468 · CBK
Versamed Medical Systems, Inc.
Anesthesiology · 65d
Cleared Nov 17, 2004
GEM-TWIN TENS/ MODELS GM3XY/Z
K042559 · GZJ
Gemore Technology Co, Ltd.
Neurology · 57d
Cleared Nov 17, 2004
TIDI BRAND STERILIZATION WRAP
K042580 · FRG
Banta Healthcare Group, Ltd.
General Hospital · 56d
Cleared Nov 17, 2004
WRISTORE DISTAL RADIUS FRACTURE FIXATOR, 4600 SERIES
K042761 · KTT
Zimmer, Inc.
Orthopedic · 43d
Cleared Nov 17, 2004
POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES
K042830 · LYZ
Grand Work Plastic Products Co., Ltd.
General Hospital · 35d
Cleared Nov 17, 2004
HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, HOSPIRA GEMSTAR CONNECT SOFTWARE
K042980 · FRN
Hospira, Inc.
General Hospital · 19d