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
170665–170688 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 12, 1979
TINNITUS MASKERS MODEL S584
K790190 · KLW
Vican Instrument Co.
Ear, Nose, Throat · 17d
Cleared Feb 12, 1979
VENTILATION TUBE, SHEEHY COLLAT
K790216 · ETD
Xomed, Inc.
Ear, Nose, Throat · 13d
Cleared Feb 12, 1979
EARETTE HEARING AID
K790228 · ESD
Oticon Corp.
Ear, Nose, Throat · 10d
Cleared Feb 12, 1979
TRANSVERSE TRACTION ASSEMBLY
K790238 · KWP
Zimmer, Inc.
Orthopedic · 11d
Cleared Feb 12, 1979
CANNULAS
K790243 · HMX
Visitec Co.
Ophthalmic · 45d
Cleared Feb 12, 1979
CYSTOTOMES
K790244 · HNY
Visitec Co.
Ophthalmic · 45d
Cleared Feb 09, 1979
IMPLANT, H.P. CONDYLAR
K781870 · KWD
Dow Corning Corp. Healthcare...
Orthopedic · 98d
Cleared Feb 09, 1979
SURGICAL EYE SHIELD
K781960 · HJK
Concept, Inc.
Ophthalmic · 80d
Cleared Feb 09, 1979
HVG-100
K790033 · IPF
Elmed, Inc.
Physical Medicine · 37d
Cleared Feb 08, 1979
PRESSURIZER, EXETER CEMENT
K781792 · KIZ
Howmedica Corp.
Pathology · 106d
Cleared Feb 08, 1979
ELECTRODE, MODEL 030-324
K781822 · DTD
Telectronics, Inc.
Cardiovascular · 104d
Cleared Feb 08, 1979
ELECTRODE, MODEL 030-326
K781823 · DTD
Telectronics, Inc.
Cardiovascular · 104d
Cleared Feb 08, 1979
ELECTRODE, MODEL 030-324/4 GUAGE
K781824 · DTD
Telectronics, Inc.
Cardiovascular · 104d
Cleared Feb 08, 1979
RIA KIT, QUANTITOPE IGE
K781904 · DGC
Kallestad Laboratories, Inc.
Immunology · 87d
Cleared Feb 08, 1979
CONTROL STRIP FOR VISUAL URINALYSIS
K781961 · JJW
Miles Laboratories, Inc.
Chemistry · 79d
Cleared Feb 08, 1979
LASER COAGULATOR, MODEL 41AK
K781965 · HQF
Lasertek OY
Ophthalmic · 76d
Cleared Feb 08, 1979
SERACON-A
K782037 · JIX
Bhp Diagnostix, Inc.
Chemistry · 64d
Cleared Feb 08, 1979
SERACON-C
K782038 · JJY
Bhp Diagnostix, Inc.
Chemistry · 64d
Cleared Feb 08, 1979
COAGULATOR, MODEL 40 AARGON
K782106 · HQF
Lasertek OY
Ophthalmic · 57d
Cleared Feb 08, 1979
PULSE GENERATOR, IMPLANTABLE CARDIAC
K782149 · DXY
Telectronics, Inc.
Cardiovascular · 44d
Cleared Feb 08, 1979
SERACON-HDL
K782171 · JJX
Bhp Diagnostix, Inc.
Chemistry · 41d
Cleared Feb 08, 1979
BIPOLAR, STANICOR LAMBDA MODEL 236,235
K790014 · DXY
Cordis Corp.
Cardiovascular · 36d
Cleared Feb 08, 1979
SERUM, LACTIC DEHYDROGENASE
K790020 · CFJ
Fisher Scientific Co., LLC
Chemistry · 36d
Cleared Feb 08, 1979
ANALYZER, MODEL CC-720
K790026 · GKL
Sysmex Corp.
Hematology · 36d