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
159193–159216 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 03, 1982
ADVANCE TM EMIT(R) & TM AMIKACIN ASSAY
K823370 · KJI
Syva Co.
Toxicology · 23d
Cleared Dec 03, 1982
OCTAGONAL ALUMINUM FRAMING SYSTEM
K823372 · HST
Orthopedic Systems, Inc.
Neurology · 21d
Cleared Dec 03, 1982
CERA 8
K823377 · EIH
Cer-Met, Inc.
Dental · 21d
Cleared Dec 03, 1982
CERA COLOR
K823378 · EIH
Cer-Met, Inc.
Dental · 21d
Cleared Dec 03, 1982
STAX FINGER SPLINTS
K823393 · ILH
Orthopedic Systems, Inc.
Physical Medicine · 21d
Cleared Dec 03, 1982
WALKING HEEL
K823394 · LGF
Orthopedic Systems, Inc.
Orthopedic · 21d
Cleared Dec 03, 1982
TRACTION-STEEL FRAMING SYSTEM
K823395 · HST
Orthopedic Systems, Inc.
Neurology · 21d
Cleared Dec 03, 1982
HEYER-SCHUTE UNIVERSAL URETERAL STENT
K823418 · LJE
American Hospital Supply Corp.
Gastroenterology & Urology · 18d
Cleared Dec 03, 1982
FISCH MODIFIED TEF-WIRE PISTON
K823429 · ETB
Treace Medical, Inc.
Ear, Nose, Throat · 17d
Cleared Dec 03, 1982
HEARING AID #G6H & G6T
K823431 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 17d
Cleared Dec 03, 1982
CAUSSE TEF-PISTON
K823439 · ETB
Treace Medical, Inc.
Ear, Nose, Throat · 17d
Cleared Dec 03, 1982
MCGEE MODIFIED STAINLESS STEEL PISTON
K823440 · ETB
Treace Medical, Inc.
Ear, Nose, Throat · 17d
Cleared Dec 03, 1982
AUSTIN MODIFIED TOTAL OSSICULAR REPLACE
K823441 · LBM
Treace Medical, Inc.
Ear, Nose, Throat · 17d
Cleared Dec 03, 1982
FISCH MODIFIED TOTAL OSSICULAR PROSTHES
K823442 · LBM
Treace Medical, Inc.
Ear, Nose, Throat · 17d
Cleared Dec 03, 1982
HERPES TRANSETTE
K823443 · JTW
Spectrum Diagnostic, Inc.
Microbiology · 17d
Cleared Dec 03, 1982
PRODUCTS IMPLANTABLE PACING LEAD,TINED
K823446 · DTB
Oscor, Inc.
Cardiovascular · 17d
Cleared Dec 03, 1982
IMPLANTABLE PACING LEAD, TINED #3262 &
K823447 · DTB
Vascular Products, Inc.
Cardiovascular · 17d
Cleared Dec 03, 1982
IMPLANTABLE PACING LEAD TINED #3390 &
K823448 · DTB
Oscor, Inc.
Cardiovascular · 17d
Cleared Dec 03, 1982
MODELS G6H, G6T, G1H & G1T
K823460 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 14d
Cleared Dec 03, 1982
MODEL H 37E
K823468 · ESD
Marcon Hearing Instruments, Inc.
Ear, Nose, Throat · 11d
Cleared Dec 03, 1982
SURE SNIP
K823485 · EFQ
South Mountain Medical
General & Plastic Surgery · 10d
Cleared Nov 30, 1982
MEDTRONIC MODELS 4011 & 4511
K822781 · DTB
Medtronic Vascular
Cardiovascular · 77d
Cleared Nov 30, 1982
RIGHT ATRIAL CATHETER
K822964 · LFJ
Quinton, Inc.
Gastroenterology & Urology · 56d
Cleared Nov 30, 1982
THE 500 MONITOR SERIES
K823052 · DXN
Vitatek
Cardiovascular · 43d