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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
150265–150288 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 08, 1985
GDC-1489 A CASTING ALLOY
K850103 · EJS
Deringer-Ney, Inc.
Dental · 28d
Cleared Feb 08, 1985
C/PES 9103, ECG STRESS TESTING SYSTEM
K850113 · DRT
Gould, Inc.
Cardiovascular · 25d
Cleared Feb 08, 1985
PORS-ON HF-SOLDER(PORCELAIN DENTAL ALLOYS)
K850193 · EJS
Degussa Dental, Inc.
Dental · 21d
Cleared Feb 07, 1985
QUIKPAGE ARRHYTHMIA REPORT GENERATOR
K841083 · DSI
Agilent Technologies
Cardiovascular · 331d
Cleared Feb 07, 1985
BIOTRONIK DNP UNIPOLAR
K841450 · DTD
Biotronik Sales, Inc.
Cardiovascular · 304d
Cleared Feb 07, 1985
BIOTRONIK DY-UNIPOLAR
K841451 · DTD
Biotronik Sales, Inc.
Cardiovascular · 304d
Cleared Feb 07, 1985
DONWAY SPLINT
K843522 · ITH
Australian Biomedical Corporation , Ltd.
Physical Medicine · 153d
Cleared Feb 07, 1985
FLUOROSCAN/TM BY HEALTHMATE
K843920 · JAA
Healthmate, Inc.
Radiology · 125d
Cleared Feb 07, 1985
SYNATOMIC STANDARD TIBIAL PLATEAU
K844355 · HSX
Depuy, Inc.
Orthopedic · 90d
Cleared Feb 07, 1985
SOLEO SUNBED
K844788
Hapro International B.V.
General & Plastic Surgery · 59d
Cleared Feb 07, 1985
TURN NEEDLE INTRAVENOUS CANNUL, NUB, W/TUBING INTE
K844917 · FPA
Turn Needle Intl., Inc.
General Hospital · 50d
Cleared Feb 07, 1985
ORIGINAL REGULAR TAMPAX TAMPONS
K844935 · HEB
Tambrands, Inc.
Obstetrics & Gynecology · 50d
Cleared Feb 07, 1985
SUPER TAMPAX TAMPONS
K844936 · HEB
Tambrands, Inc.
Obstetrics & Gynecology · 50d
Cleared Feb 07, 1985
EPICHROME PAP
K844968 · JFH
Cetus Corp.
Chemistry · 45d
Cleared Feb 07, 1985
ACE INTRAMEDULLARY ROD FOR SMALL BONES
K850142 · HSB
Buckman Co., Inc.
Orthopedic · 24d
Cleared Feb 07, 1985
COPAL DIGITAL THERMOMETER UF-12
K850195 · FLL
Takeda Medical, Inc.
General Hospital · 20d
Cleared Feb 07, 1985
COPAL DIGITAL THERMOMETER UF-22B
K850196 · FLL
Takeda Medical, Inc.
General Hospital · 20d
Cleared Feb 07, 1985
ISOCONTROL SERUM LD-
K850211 · JJT
Sclavo, Inc.
Chemistry · 23d
Cleared Feb 07, 1985
ISOENZYME TEST CK-MB
K850212 · CGS
Sclavo, Inc.
Chemistry · 23d
Cleared Feb 07, 1985
BREWER HEAVE-DUTY I.V. STAND W/FOOT OPERATED PNUEM
K850245 · FOX
E.F. Brewer Co.
General Hospital · 16d
Cleared Feb 07, 1985
BCS POTASSIUM TURBIDIMETRIC TEST
K850258 · CEJ
Bioclinical Systems, Inc.
Chemistry · 16d
Cleared Feb 06, 1985
SURGICAL MODULE 7000 ECG
K840869 · DPS
Marquette Electronics, Inc.
Cardiovascular · 345d
Cleared Feb 06, 1985
ANTERIOR CRUCIATE LIGAMENT GRASPER
K841241 · HRX
Surgical Products Corp.
Orthopedic · 320d
Cleared Feb 06, 1985
MICRO ORGANISM GROWTH SYS-M1000
K843000 · LIO
Hml Inc/Biotechnology Transfer
Microbiology · 191d