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
168529–168552 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 27, 1979
RIONET HEARING AID HB-68L
K792506 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 23d
Cleared Dec 27, 1979
IREX CARDIOPLAN
K792525 · DQK
Irex Corp.
Cardiovascular · 21d
Cleared Dec 27, 1979
PLAQUE-X DENTURE CLEANER
K792530 · JER
Nexell Corp.
Dental · 20d
Cleared Dec 27, 1979
TRYPTOSE BLOOD AGAR BASE & TRYPTOSE
K792543 · JSG
Isle Media and Sterile Products, Inc.
Microbiology · 17d
Cleared Dec 27, 1979
LYSINE IRON AGAR
K792544 · JSH
Isle Media and Sterile Products, Inc.
Microbiology · 17d
Cleared Dec 27, 1979
CONTAINER SYSTEM
K792558 · FLE
Aesculap Instruments Corp.
General Hospital · 15d
Cleared Dec 27, 1979
BACTEC BACTERIAL DETECTION SYSTEM
K792575 · JTA
Bd Becton Dickinson Vacutainer...
Microbiology · 14d
Cleared Dec 20, 1979
ACCESSORIES FOR SYS. 400 CO2 SURG. LASER
K791895 · GEX
Coherent Medical Division
General & Plastic Surgery · 86d
Cleared Dec 20, 1979
P1806 MOBILE C-ARM IMAGE INTENSIFIER
K792225 · JAA
Precise Optics
Radiology · 45d
Cleared Dec 20, 1979
MULTI-AD FLUID DISPENSING SYSTEM
K792227 · KYX
National Patent Development Corp.
General Hospital · 45d
Cleared Dec 20, 1979
SORBIES
K792295 · FRL
American Hospital Supply Corp.
General Hospital · 37d
Cleared Dec 20, 1979
SPAN AIDS KIT
K792297 · FMP
American Hospital Supply Corp.
General Hospital · 34d
Cleared Dec 20, 1979
THE VERSA-BED
K792298 · FNJ
First & Ten, Inc.
General Hospital · 37d
Cleared Dec 20, 1979
A SLEEP ASSESSMENT DEVICE
K792305 · LEL
Farrall Instruments, Inc.
Neurology · 34d
Cleared Dec 20, 1979
SKIL-CARE TURN AND HOLD PAD
K792318 · FMR
Skil-Care Corp.
General Hospital · 31d
Cleared Dec 20, 1979
INTEGRON
K792327 · IZF
Tecnomed, Inc.
Radiology · 31d
Cleared Dec 20, 1979
TOMMY TOES
K792331 · FQM
Tommy Toes
General Hospital · 31d
Cleared Dec 20, 1979
STONE AND RETRIEVAL BASKET
K792344 · FFL
Mill-Rose Laboratory
Gastroenterology & Urology · 31d
Cleared Dec 20, 1979
RETRIEVABLE FORCEPS
K792345 · OCZ
Mill-Rose Laboratory
Gastroenterology & Urology · 31d
Cleared Dec 20, 1979
STOMAHESIVE POWDER
K792382 · EXB
E. R. Squibb & Sons, Inc.
Gastroenterology & Urology · 24d
Cleared Dec 20, 1979
OCTOSON
K792388 · IYO
Ausonics Pty , Ltd.
Radiology · 24d
Cleared Dec 20, 1979
POLYPHOS
K792392 · IZO
Siemens Corp.
Radiology · 24d
Cleared Dec 20, 1979
GIGANTOS 1012 MP
K792393 · IZO
Siemens Corp.
Radiology · 24d
Cleared Dec 20, 1979
SIRCAM 106
K792394 · IZJ
Siemens Corp.
Radiology · 24d