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
153553–153576 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 09, 1984
NARCOTRACE 40 - NT40
K833656 · DSF
Narco Bio-Systems
Cardiovascular · 202d
Cleared May 09, 1984
DIASONICS DLA-100
K833667 · IYO
Diasonics, Inc.
Radiology · 203d
Cleared May 09, 1984
BETAJECT BD U100
K833705 · FMI
Orange Medical Instruments, Inc.
General Hospital · 204d
Cleared May 09, 1984
GALLIE CRYONUCLEATOR
K833747 · HPS
Mono Research Laboratories
Ophthalmic · 196d
Cleared May 09, 1984
M305
K833819 · DXJ
Burkick Corp.
Cardiovascular · 189d
Cleared May 09, 1984
E 310 ELECTROCARDIOGRAPH
K833951 · DPS
Burdick Corp.
Cardiovascular · 176d
Cleared May 09, 1984
MINOLTA SM-32 OXYGEN SATURATION MONIT
K833973 · DQA
Marquest Medical Products, Inc.
Anesthesiology · 175d
Cleared May 09, 1984
MODEM ACCESSORY FOR EPI CARDIA SYS
K834034 · DXH
Medicomp, Inc.
Cardiovascular · 168d
Cleared May 09, 1984
ULTRASOUND SCANNER 501
K834284 · IYO
Imex Medical Systems, Inc.
Radiology · 166d
Cleared May 09, 1984
SWITCHING UNIT ELECTRODE CATHETER
K834602 · DRF
Webster Laboratories, Inc.
Cardiovascular · 131d
Cleared May 09, 1984
IREX 720 SECTOR SCANNER
K840139 · IYO
Irex Corp.
Radiology · 126d
Cleared May 09, 1984
HEALTHCHECK AUTO INFLATE DIGITAL BP
K840228 · DXN
Timex Medical Products Corp.
Cardiovascular · 110d
Cleared May 09, 1984
NON STRESS TEST MONITOR 507
K840285 · HGH
Imex Medical Systems, Inc.
Obstetrics & Gynecology · 106d
Cleared May 09, 1984
CAT. 7-EAR, NOSE & THROAT DEVICES
K840311 · KCP
Imm Enterprises , Ltd.
Ear, Nose, Throat · 106d
Cleared May 09, 1984
AUDIO BANDWIDTH ANALYZER
K840402 · IYN
D. E. Hokanson, Inc.
Radiology · 99d
Cleared May 09, 1984
OPTHERM FINE TIP
K840425 · HQP
Suncoast Medical Manufacturers, Inc.
Ophthalmic · 99d
Cleared May 09, 1984
OPTHERM EXTRA FINE TIP
K840426 · HQP
Suncoast Medical Manufacturers, Inc.
Ophthalmic · 99d
Cleared May 09, 1984
SUN-LITE BLUE SPOT
K840427
Suncoast Medical Manufacturers, Inc.
Ophthalmic · 99d
Cleared May 09, 1984
SUN-LITE PEN LIGHT
K840428
Suncoast Medical Manufacturers, Inc.
Ophthalmic · 99d
Cleared May 09, 1984
SUN-LITE WHITE SLIT
K840430
Suncoast Medical Manufacturers, Inc.
Ophthalmic · 99d
Cleared May 09, 1984
BIOPSY ATTACHMENT
K840451 · IYO
Elscint, Inc.
Radiology · 98d
Cleared May 09, 1984
SUN-LITE BLUE SLIT
K840492 · HTP
Suncoast Medical Manufacturers, Inc.
Orthopedic · 93d
Cleared May 09, 1984
TECHNICARE MODEL 330
K840540 · IYO
Technicare Corp.
Radiology · 91d
Cleared May 09, 1984
FLEISCHMAN-SWARTZ ENDO-OCULAR PROBE
K840590 · HQF
Hgm, Inc.
Ophthalmic · 90d