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
162985–163008 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 19, 1981
ULTRA-DIG
K812749 · LCS
Antibodies, Inc.
Toxicology · 20d
Cleared Oct 19, 1981
AMES TDA QUINIDINE TEST
K812753 · LBZ
Miles Laboratories, Inc.
Toxicology · 20d
Cleared Oct 19, 1981
BECKMAN ASTRA SYSTEMS DIRECT BILIRUBIN
K812754 · CIG
Beckman Instruments, Inc.
Chemistry · 19d
Cleared Oct 19, 1981
NML CK-MB RIA
K812759 · JHX
Nuclear Medical Laboratories, Inc.
Chemistry · 18d
Cleared Oct 19, 1981
PERITONEAL DIALYSIS DRAINAGE
K812771 · KDJ
Dravon Medical, Inc.
Gastroenterology & Urology · 14d
Cleared Oct 19, 1981
PERITONEAL DIALYSIS CYCLER SET (8UNIT)
K812772 · KDJ
Dravon Medical, Inc.
Gastroenterology & Urology · 14d
Cleared Oct 19, 1981
DIRECT IRON REAGENT SET
K812777 · JIY
The Dow Chemical Co.
Chemistry · 14d
Cleared Oct 16, 1981
DRESSING CHANGE TRAYS & STERILE SPONGES
K811951 · EFQ
O.R. Specialties, Inc.
General & Plastic Surgery · 101d
Cleared Oct 14, 1981
PROXIMAL INTERPHALANGEAL JOINT IMPLANT
K802342 · JDI
Sutter Biomedical, Inc.
Orthopedic · 383d
Cleared Oct 14, 1981
BIO-TONE MODEL 4
K811737 · IPF
Biotone International, Inc.
Physical Medicine · 117d
Cleared Oct 14, 1981
OPERATING ROOM KIT
K811916 · FSM
American Hospital Supply Corp.
General & Plastic Surgery · 105d
Cleared Oct 14, 1981
EARSCAN
K812529 · EWO
Micro Audiometrics Corp.
Ear, Nose, Throat · 42d
Cleared Oct 14, 1981
TEMP-FILL
K812532 · EMA
Madrid Uso, Jr., D.D.S.
Dental · 42d
Cleared Oct 13, 1981
ATRIAL ENDOCARDIAL ELECTRODE LEAD OF J
K811593 · DTB
Telectronics, Inc.
Cardiovascular · 127d
Cleared Oct 13, 1981
TROCAR & TROCAR SLEEVES
K812199 · HET
Reznik Instruments
Obstetrics & Gynecology · 70d
Cleared Oct 13, 1981
ELECTROSURGICAL UNIT
K812203 · GEI
Reznik Instruments
General & Plastic Surgery · 70d
Cleared Oct 13, 1981
UTERINE MANIPULATORS
K812204 · KOH
Reznik Instruments
Obstetrics & Gynecology · 70d
Cleared Oct 13, 1981
LAPAROSCOPE
K812206 · HET
Reznik Instruments
Obstetrics & Gynecology · 70d
Cleared Oct 13, 1981
KALOS-03
K812218 · DXY
Biotronik Sales, Inc.
Cardiovascular · 68d
Cleared Oct 13, 1981
TOUCHLESS HOME-CATH
K812281 · KOD
Diamed Division Ill. Tool Works, Inc.
Gastroenterology & Urology · 61d
Cleared Oct 13, 1981
DORROS-SPRING PRESSURIZER
K812304 · MAV
Cardiovascular Diagnostic Services
Cardiovascular · 56d
Cleared Oct 13, 1981
4001 CT SCANNER
K812393 · JAK
Omnimedical
Radiology · 54d
Cleared Oct 13, 1981
SUNLAMP
K812446 · FTC
The Richmond Light Co.
Radiology · 46d
Cleared Oct 13, 1981
TANDEM QUALITATIVE HCG KIT
K812461 · JHI
Hybritech, Inc.
Chemistry · 43d