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
75361–75384 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 14, 2002
507EL VITAL SIGNS MONITOR
K022435 · DRT
Criticare Systems, Inc.
Cardiovascular · 20d
Cleared Aug 14, 2002
K-ASSAY HS-CRP CONTROLS
K022486 · DCK
Kamiya Biomedical Co.
Immunology · 16d
Cleared Aug 13, 2002
ELECTROPHYSIOLOGY CATHETER
K012708 · NLH
Alliance Medical Corp.
Cardiovascular · 364d
Cleared Aug 13, 2002
CERALAS D DIODE LASER SYSTEM, MODEL # D50
K013691 · GEX
Biolitec, Inc.
General & Plastic Surgery · 279d
Cleared Aug 13, 2002
GLOVCO EBONY
K013828 · LYY
Glovco (M) Sdn. Bhd.
General Hospital · 267d
Cleared Aug 13, 2002
DELTEC INSULIN INFUSION PUMP AND ACCESSORIES
K020655 · LZG
Deltec, Inc.
General Hospital · 165d
Cleared Aug 13, 2002
7600 SERIES REUSABLE FULL-FACE CPAP/NIPPV MASKS MODELS 7620 LARGE, 7630...
K020759 · BZD
Hans Rudolph, Inc.
Anesthesiology · 159d
Cleared Aug 13, 2002
PURITAN-BENNETT 840 VENTILATIOR SYSTEM WITH VOLUME VENTILATION PLUS OPTION
K021573 · CBK
Puritan-Bennett
Anesthesiology · 91d
Cleared Aug 13, 2002
96 CHANNEL EEG HEADBOX MODEL EMU96
K021599 · GWQ
Excel Tech. , Ltd.
Neurology · 90d
Cleared Aug 13, 2002
ISA-21 INTERVENTIONAL SPINE ARRAY COIL
K021631 · MOS
Mri Devices Corp.
Radiology · 88d
Cleared Aug 13, 2002
MHS MED LIGHT 1000
K021956 · ILY
Micro Health Systems, Inc.
Physical Medicine · 61d
Cleared Aug 13, 2002
GRIPPER PLUS NEEDLE
K021999 · FPA
Deltec, Inc.
General Hospital · 55d
Cleared Aug 13, 2002
SPHERZ
K022074 · HAW
I.Z.I. Corp.
Neurology · 48d
Cleared Aug 13, 2002
SURFACE ELECTRODE FOR ELECTROENCEPHALOGRAPHY
K022197 · GXY
The Electrode Store, Inc.
Neurology · 39d
Cleared Aug 13, 2002
MODIFICATION TO ISOLA SPINAL SYSTEM
K022285 · MNI
Depuyacromed
Orthopedic · 29d
Cleared Aug 13, 2002
EMS PIEZON MASTER 600
K022328 · ELC
Electro Medical Systems SA
Dental · 26d
Cleared Aug 13, 2002
3D NAVIGATION INTERFACE FOR SIREMOBILE ISO-C 3D
K022337 · IZL
Siemens Medical Solutions USA, Inc.
Radiology · 26d
Cleared Aug 13, 2002
ULTRAGUIDE CTG 2000SA
K022354 · JAK
Ultraguide , Ltd.
Radiology · 25d
Cleared Aug 13, 2002
HRH-127-8 HEAD ARRAY COIL
K022372 · MOS
Mri Devices Corp.
Radiology · 22d
Cleared Aug 13, 2002
1.5T SCANMED PV ARRAY
K022395 · MOS
Medic, Inc.
Radiology · 21d
Cleared Aug 13, 2002
SENSA-CUFF, MODELS INFANT, CHILD, ADULT
K022482 · DXQ
Ge Medical Systems Information...
Cardiovascular · 15d
Cleared Aug 13, 2002
BRUNO ELECTRA-RIDE, MODEL SRE-2700
K022509 · ILK
Bruno Independent Living Aids, Inc.
Physical Medicine · 14d
Cleared Aug 13, 2002
SEQUOIA SIGNATURE II DIAGNOSTIC ULTRASOUND SYSTEM
K022567 · IYN
Acuson Corp.
Radiology · 11d
Cleared Aug 12, 2002
MODIFICATION TO RELIEF BRIEF
K003128 · NJB
The JM Kohn Co.
Physical Medicine · 675d