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
163993–164016 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 26, 1981
RIONET HEARING AID HB-69S
K811529 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 25d
Cleared Jun 26, 1981
RIONET HEARING AID HB 69 T
K811530 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 25d
Cleared Jun 26, 1981
RIONET HEARING AID HB-69
K811531 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 25d
Cleared Jun 26, 1981
LO-VOL I.V. SETS
K811561 · FPA
Sea Medical Products, Inc.
General Hospital · 23d
Cleared Jun 26, 1981
GLASSMAN-DORMIA GALLSTONE EXTRACTOR SET
K811580 · FFL
Porges Catheter Corp.
Gastroenterology & Urology · 21d
Cleared Jun 26, 1981
VISIO-SEAL
K811624 · EBC
Espe-Premier Sales Co.
Dental · 17d
Cleared Jun 26, 1981
ETHIX FEEDING TUBES POLYURETHANE/RADIOP.
K811639 · KNT
Ethox Corp.
Gastroenterology & Urology · 16d
Cleared Jun 26, 1981
ANIS LENS IMPLANT FORCEPS #2
K811658 · HNR
American V. Mueller
Ophthalmic · 14d
Cleared Jun 26, 1981
CREATININE REAGENT
K811659 · CGX
Gilford Diagnostics
Chemistry · 14d
Cleared Jun 26, 1981
NORELCO ELECTRONIC DIGITAL THERMOMETER
K811672 · FLL
North American Philips Corp.
General Hospital · 11d
Cleared Jun 26, 1981
FORDER RETRACTOR
K811693 · KOA
Dacomed Corp.
Gastroenterology & Urology · 11d
Cleared Jun 25, 1981
ACTH RADIOIMMUNOASSAY KIT
K811565 · CKG
Immuno Nuclear Corp.
Chemistry · 21d
Cleared Jun 25, 1981
C-TERMINAL PTH BY RADIOIMMUNOASSAY KIT
K811566 · CEW
Immuno Nuclear Corp.
Chemistry · 21d
Cleared Jun 25, 1981
CARDIOZYME PLUS CK-MB ITEM #65045
K811573 · JHW
Harleco
Chemistry · 21d
Cleared Jun 25, 1981
CARDIOZYME PLUS CK-TOTAL ITEM #65046
K811574 · CGS
Harleco
Chemistry · 21d
Cleared Jun 25, 1981
CARDIOZYME PLUS CK-MB ITEM #65045 (G)
K811575 · JHW
Harleco
Chemistry · 21d
Cleared Jun 25, 1981
CARDIOZYME PLUS CK-TOTAL ITEM #65046 (A)
K811576 · CGS
Harleco
Chemistry · 21d
Cleared Jun 25, 1981
HELENA FETAL-TEK 200 METHOD
K811588 · JHG
Helena Laboratories
Chemistry · 17d
Cleared Jun 25, 1981
ZIMMER ARTHROSCOPY SYSTEM
K811596 · HRX
Zimmer, Inc.
Orthopedic · 17d
Cleared Jun 25, 1981
UREA AGAR SLANT
K811597 · JSH
Micro Media Laboratories
Microbiology · 17d
Cleared Jun 25, 1981
DNASE AGAR MEDIA
K811598 · JSI
Micro Media Laboratories
Microbiology · 17d
Cleared Jun 25, 1981
EOSIN METHYLENE BLUE AGAR
K811599 · JSI
Micro Media Laboratories
Microbiology · 17d
Cleared Jun 25, 1981
BILE ESCULIN MEDIA
K811600 · JSI
Micro Media Laboratories
Microbiology · 17d
Cleared Jun 25, 1981
PHENYETHYL ALCOHOL AGAR
K811601 · JSJ
Micro Media Laboratories
Microbiology · 17d