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
150385–150408 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 23, 1985
HEARING AID, UNITRON UE12-PPL
K843246 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 156d
Cleared Jan 23, 1985
IMSI/METRIPOND GRIPPER PLATE
K843370 · HRS
Intl. Management Services, Inc.
Orthopedic · 148d
Cleared Jan 23, 1985
MECON X (TEN)
K843484 · ESD
Mecon Labs
Ear, Nose, Throat · 139d
Cleared Jan 23, 1985
MODEL P23XL PHYSIOLOGICAL PRESSURE TRANSDUCER
K843969 · DXO
Gould, Inc.
Cardiovascular · 104d
Cleared Jan 23, 1985
SONOCARE
K844034 · DYO
Echo Ultrasound
Dental · 99d
Cleared Jan 23, 1985
DR. HESSEL'S INSECT POISON REMOVER
K844048 · KYP
Medie Group
General Hospital · 98d
Cleared Jan 23, 1985
BIOBRANE BRAND TEMP. WOUND DRESSING W/ADHESIVE
K844052
Woodroof Laboratories, Inc.
General & Plastic Surgery · 97d
Cleared Jan 23, 1985
MEDO BUBBLE BATH MA-80, 400, 600 & 700
K844064 · ILJ
Medo U.S.A., Inc.
Physical Medicine · 97d
Cleared Jan 23, 1985
ELECTRO-NERVE STIMULATOR B5/SK700B
K844076 · GZJ
Biomedical Life Systems, Inc.
Neurology · 96d
Cleared Jan 23, 1985
ULTRASONIC SCANNER CALIBRATION & TEST OBJECTS
K844120 · GXX
Echo Ultrasound
Neurology · 92d
Cleared Jan 23, 1985
HOLDSTER ARM RETENTION SYSTEM
K844157
P.G.L. Medical
Physical Medicine · 91d
Cleared Jan 23, 1985
PREMIE COMFORT PAD PATIENT & INFANT SUPPORT PADS
K844176 · FRP
Premie Comfort Products
General Hospital · 90d
Cleared Jan 23, 1985
ULTRASONIC SCANNER CALIBRATION & TEST PHANTOMS
K844247 · GXX
Technicare Corp.
Neurology · 83d
Cleared Jan 23, 1985
OSADA ENAC
K844250 · ELC
Osada Electric Co., Ltd.
Dental · 82d
Cleared Jan 23, 1985
FISHER DIAG. PREGNACLONE TUBE PREGNANCY TEST KIT
K844347 · JHJ
Fisher Diagnostics
Chemistry · 75d
Cleared Jan 23, 1985
POROCOAT NEW JERSEY SHOULDER REPLACEMENT SYS
K844415 · MBF
Depuy, Inc.
Orthopedic · 70d
Cleared Jan 23, 1985
HIGH RESOLUTION 5 MHZ LINEAR ARRAY
K844449 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 68d
Cleared Jan 23, 1985
CIVCO SCAN DRAPE
K844472 · IYO
CIVCO Medical Instruments Co., Inc.
Radiology · 65d
Cleared Jan 23, 1985
STORZ CORNEO-SCAN II CS2000
K844477 · IYO
Storz Instrument Co.
Radiology · 65d
Cleared Jan 23, 1985
ADVANCED HEARING INSTRUMENTS - HEARING AIDS
K844728 · ESD
Advanced Hearing Instruments
Ear, Nose, Throat · 50d
Cleared Jan 23, 1985
CARDIO IV/GXT STRESS TESTING SYSTEM
K844744 · DPS
Intl. Medical, Inc.
Cardiovascular · 49d
Cleared Jan 23, 1985
HEMOCLIP X-20 AUTOMATIC HEMOCLIP LIGATING APPLIER
K844836 · GWD
Edward Weck, Inc.
Microbiology · 42d
Cleared Jan 23, 1985
VISISTAT SKIN STAPLING DEVICE
K844837 · GDT
Edward Weck, Inc.
General & Plastic Surgery · 42d
Cleared Jan 23, 1985
SKIN STAT II SKIN STAPLING MEDICAL DEVICE
K844838 · GDT
Edward Weck, Inc.
General & Plastic Surgery · 42d