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
74545–74568 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 01, 2002
PLAYTEX BREAST PUMP
K022594 · HGX
Playtex Products, Inc.
Obstetrics & Gynecology · 88d
Cleared Nov 01, 2002
K-FIX
K022597 · HTY
New Deal, S.A.
Orthopedic · 88d
Cleared Nov 01, 2002
AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST STRIP (DIPSTICK)
K022680 · DHA
Azog, Inc.
Chemistry · 81d
Cleared Nov 01, 2002
AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST (DEVICE OR CASSETTE)
K022681 · DHA
Azog, Inc.
Chemistry · 81d
Cleared Nov 01, 2002
STEPHENS DISPOSABLE FORCEPS
K022835 · HNR
Stephens Instruments
Ophthalmic · 66d
Cleared Nov 01, 2002
STEPHENS DISPOSABLE SPECULUM
K022836 · HNC
Stephens Instruments
Ophthalmic · 66d
Cleared Nov 01, 2002
STEPHENS DISPOSABLE SCISSORS
K022840 · HNF
Stephens Instruments
Ophthalmic · 66d
Cleared Nov 01, 2002
STEPHENS DISPOSABLE HOOKS
K022842 · HNQ
Stephens Instruments
Ophthalmic · 66d
Cleared Nov 01, 2002
GAYHEART CORNEAL EXCISION DEVICE
K022843 · HRH
Stephens Instruments
Ophthalmic · 66d
Cleared Nov 01, 2002
WIENER LAB. BILIRRUBINA TOTAL AA
K022962 · CIG
Wiener Laboratories Saic
Chemistry · 56d
Cleared Nov 01, 2002
LUCIUS 76
K023196 · EJT
Sb Lucius, Inc.
Dental · 37d
Cleared Nov 01, 2002
CERANUM 90
K023198 · EJT
Sb Lucius, Inc.
Dental · 37d
Cleared Nov 01, 2002
CONTROL PLASMA N
K023309 · GIZ
Dade Behring, Inc.
Hematology · 29d
Cleared Nov 01, 2002
CONTROL PLASMA P
K023312 · GGC
Dade Behring, Inc.
Hematology · 29d
Cleared Nov 01, 2002
ULTRASOUND SCANNER, TYPE 1101
K023457 · IYO
B & K Medical A/S
Radiology · 17d
Cleared Nov 01, 2002
TIMEX ACCUCURVE TALKING 30 SECOND THERMOMTER
K023538 · FLL
Medport, Inc.
General Hospital · 11d
Cleared Oct 31, 2002
SHERLOCK MYCOBACTERIA IDENTIFICATION SYSTEM
K020689 · NJO
Midi, Inc.
Microbiology · 241d
Cleared Oct 31, 2002
DIGITAL TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL EV-803 DIGITAL TENS
K020749 · GZJ
Everyway Medical Instruments Co.,Ltd
Neurology · 238d
Cleared Oct 31, 2002
DIGITAL ELECTRICAL MUSCLE STIMULATOR, MODEL EV-807 DIGITAL EMS
K020750 · IPF
Everyway Medical Instruments Co.,Ltd
Physical Medicine · 238d
Cleared Oct 31, 2002
PERMACOL
K021056 · FTM
Tissue Science Laboratories, Plc
General & Plastic Surgery · 213d
Cleared Oct 31, 2002
MEDCOMP REPAIR KIT, MODEL ASPCRPK
K022570 · NFK
Medcomp
Gastroenterology & Urology · 90d
Cleared Oct 31, 2002
FLASH 1
K022583 · GEX
Emed, Inc.
General & Plastic Surgery · 87d
Cleared Oct 31, 2002
NEURORECOVERY VENTRICULAR CATHETER & MAIN VALVE ASSEMBLY KIT
K022638 · GWM
Neurorecovery, Inc.
Neurology · 84d
Cleared Oct 31, 2002
KERADEC
K022663 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 83d