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
170785–170808 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 26, 1979
MODULE PERSONAL EAR (DELUXE)
K790095 · ESD
Qualitone
Ear, Nose, Throat · 10d
Cleared Jan 26, 1979
VALVE, H-H CRUCIFORM SLIT
K790126 · JXG
Holter-Hausner Intl.
Neurology · 2d
Cleared Jan 25, 1979
SCANNER-SV
K782158 · IYO
Hrl, Inc.
Radiology · 34d
Cleared Jan 25, 1979
ARTERIAL EXTENSION SET
K790082 · DQO
Namic
Cardiovascular · 13d
Cleared Jan 25, 1979
CATHETER, ARTERIAL LINE
K790083 · DQY
Namic
Cardiovascular · 13d
Cleared Jan 24, 1979
ISOLATION SLEEVE, MODEL 349-01
K790098 · DXY
Intermedics, Inc.
Cardiovascular · 8d
Cleared Jan 24, 1979
ISOLATION SLEEVE, MODEL 347-01
K790099 · DXY
Intermedics, Inc.
Cardiovascular · 8d
Cleared Jan 24, 1979
ISOLATION SLEEVE, MODEL 348-01
K790100 · DXY
Intermedics, Inc.
Cardiovascular · 8d
Cleared Jan 24, 1979
ISOLATION SLEEVE, MODEL 346-01
K790101 · DXY
Intermedics, Inc.
Cardiovascular · 8d
Cleared Jan 23, 1979
PUMP, BALLOON MODEL 10
K781848 · DSP
Avco Medical Products
Cardiovascular · 92d
Cleared Jan 23, 1979
TREMOR MONITOR
K782036 · GYD
Columbus Instruments Intl. Corp.
Neurology · 49d
Cleared Jan 23, 1979
STOPCOCKS, MANIFOLDS
K782095 · DTL
Namic
Cardiovascular · 36d
Cleared Jan 22, 1979
SILASTIC NEPHROSTOMY SYSTEM
K781664 · GBO
Dow Corning Corp. Healthcare...
General & Plastic Surgery · 116d
Cleared Jan 22, 1979
RESPIRATOR/GILL 1/SIMV
K781706 · CBO
Chemetron Medical Products, Inc.
Anesthesiology · 104d
Cleared Jan 22, 1979
CATHETER, AKRON FOLEY TEFLON
K781751 · KOD
Latex Ind., Inc.
Gastroenterology & Urology · 98d
Cleared Jan 22, 1979
LASER SYSTEM, SHARPLAN 791/HE, CO2
K782030 · GEX
Laser Industries , Ltd.
General & Plastic Surgery · 48d
Cleared Jan 22, 1979
HEARING AID, MODEL GB
K782121 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 26d
Cleared Jan 22, 1979
HEARING AID, MODEL AA
K782122 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 26d
Cleared Jan 22, 1979
PRESSURE ALARM
K782174 · CAP
Thompson Respiration Products, Inc.
Anesthesiology · 34d
Cleared Jan 22, 1979
ICE PACK, REUSABLE FLEXIBLE
K790009 · IME
Ackrad Laboratories
Physical Medicine · 20d
Cleared Jan 18, 1979
MONITOR, OXYCHEK OXYGEN
K782114 · CCL
Critikon Company, LLC
Anesthesiology · 29d
Cleared Jan 17, 1979
LIDOCAINE CALIBRATOR KIT
K780731 · DLJ
Vitek Systems, Inc.
Toxicology · 260d
Cleared Jan 17, 1979
CORDIA R
K780885 · GOL
Cordis Corp.
Microbiology · 236d
Cleared Jan 17, 1979
MIRROR WARMER
K781750 · KAI
Arleton Technical Products, Inc.
Ear, Nose, Throat · 93d