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
168481–168504 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 31, 1979
HELENA FACTOR IX DEFICIENT SUBSTRATE
K792475 · GGP
Helena Laboratories
Hematology · 28d
Cleared Dec 31, 1979
HELENA FACTOR XI DEFICIENT SUBSTRATE
K792476 · GGP
Helena Laboratories
Hematology · 28d
Cleared Dec 31, 1979
CULTURE PLATES & TUBED MEDIA
K792481 · JTZ
Laboratory Products, Inc.
Microbiology · 42d
Cleared Dec 31, 1979
SERACON-SRI
K792485 · JIX
Bhp Diagnostix, Inc.
Chemistry · 28d
Cleared Dec 31, 1979
SERACON-SRI (PROD. # D029
K792486 · JIX
Bhp Diagnostix, Inc.
Chemistry · 28d
Cleared Dec 31, 1979
SERACON-SRII
K792487 · JIX
Bhp Diagnostix, Inc.
Chemistry · 28d
Cleared Dec 31, 1979
VOLU-SOL NMB RETICULOCYTE STAIN
K792496 · KQC
Volu Sol Medical Industries
Hematology · 27d
Cleared Dec 31, 1979
SANDARE CYANMETHEMOGLOBIN REAGENT
K792503 · KHG
Sandare Chemical Co., Inc.
Hematology · 27d
Cleared Dec 31, 1979
HELENA FACTOR V DEFICIENT SUBSTRATE
K792507 · GGP
Helena Laboratories
Hematology · 27d
Cleared Dec 31, 1979
HELENA FACTOR X DEFICIENT SUBSTRATE
K792508 · GGP
Helena Laboratories
Hematology · 27d
Cleared Dec 31, 1979
HELENA FACTOR VII DEFICIENT SUB. PLASMA
K792511 · GGP
Helena Laboratories
Hematology · 26d
Cleared Dec 31, 1979
VOGEL-JOHNSON AGAR
K792542 · JSH
Isle Media and Sterile Products, Inc.
Microbiology · 21d
Cleared Dec 31, 1979
PATIENT TROLLEY B49
K792570 · FPO
Ets Rene Marzet
General Hospital · 18d
Cleared Dec 31, 1979
ALARM USED W/MONITORING SPIROMETER
K792573 · BZK
Empire Plastics Manufacturer
Anesthesiology · 18d
Cleared Dec 31, 1979
ACA ETHOSURIMIDE TEST PACK
K792584 · DLF
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 17d
Cleared Dec 31, 1979
HALO SUPPORT JACKET & ASSOC. HARDWARE
K792586 · HAX
Depuy, Inc.
Neurology · 14d
Cleared Dec 31, 1979
PHENYLETHANOL AGAR
K792593 · JSJ
Isle Media and Sterile Products, Inc.
Microbiology · 14d
Cleared Dec 31, 1979
TRYPTIC SOY AGAR W/LECITHIN & POLYSRBTE.
K792594 · JSG
Isle Media and Sterile Products, Inc.
Microbiology · 14d
Cleared Dec 31, 1979
SF MEDIUM (SF BROTH, STREPTOCOCCUS
K792595 · JSJ
Isle Media and Sterile Products, Inc.
Microbiology · 14d
Cleared Dec 31, 1979
TRYPTIC SOY AGAR W/PHENYLETHANOL &
K792596 · JSJ
Isle Media and Sterile Products, Inc.
Microbiology · 14d
Cleared Dec 31, 1979
LIFELIFT MODELS ONE AND TWO
K792601 · FSA
Corda Int'L Holiday, Inc.
General Hospital · 13d
Cleared Dec 31, 1979
LIFELINE TLE ENDOCARDIAL PACING LEAD,
K792604 · DTB
Intermedics, Inc.
Cardiovascular · 13d
Cleared Dec 31, 1979
H-H SHUNT INTRODUCER
K792639 · GYK
Holter-Hausner Intl.
Neurology · 11d
Cleared Dec 28, 1979
PSORALITE MARK I
K791977 · KGL
Paul B. Elder Co.
General & Plastic Surgery · 87d