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
170041–170064 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 25, 1979
TEST KIT, IIF-AMA
K790295 · DBM
Medica Corp.
Immunology · 105d
Cleared May 25, 1979
TXOCELL-IHA REAGENT SYSTEM
K790460 · GMM
Calbiochem-Behring Corp.
Microbiology · 81d
Cleared May 25, 1979
RIA KIT, PROSTATIC ACID
K790580 · JFH
Monitor Science Corp.
Chemistry · 59d
Cleared May 25, 1979
ACCUTRON POLLUTION REDUCER
K790638 · BSJ
Parker Laboratories, Inc.
Anesthesiology · 56d
Cleared May 25, 1979
EMIT CFA THYROXINE ASSAY
K790686 · KLI
Syva Co.
Chemistry · 44d
Cleared May 25, 1979
MEDTRONIC MODELS 6907/6901
K790766 · DTB
Medtronic Vascular
Cardiovascular · 36d
Cleared May 25, 1979
PISCES-SELECTOR X
K790790 · GZB
Medtronic Vascular
Neurology · 31d
Cleared May 25, 1979
PURGE LINE UNIT
K790804 · DTL
Surgikos, Inc.
Cardiovascular · 31d
Cleared May 25, 1979
DISPOSA-CUF
K790810 · DXQ
Crest Medical Equipment
Cardiovascular · 29d
Cleared May 25, 1979
EGS MODEL 300
K790847 · IPF
Alfred V. Greco
Physical Medicine · 21d
Cleared May 25, 1979
GENERATOR, 16 SERIES, MODIFIED TOP CAP
K790868 · DXY
Telectronics, Inc.
Cardiovascular · 18d
Cleared May 24, 1979
TERUMO IMUGARD
K790105 · GKT
Terumo America, Inc.
Hematology · 128d
Cleared May 23, 1979
CONCEP-7-B-HCG
K790397 · JHI
Leeco Diagnostics, Inc.
Chemistry · 86d
Cleared May 23, 1979
DATA-ZYME ACIA PHOSPHATASE PROCEDURE
K790524 · CKE
Data Medical Associates, Inc.
Chemistry · 69d
Cleared May 23, 1979
ELECTRODES, STAODERM STERILE
K790542 · GXY
Staodynamics, Inc.
Neurology · 62d
Cleared May 23, 1979
STIMULATOR, NIC-106 VISUAL
K790570 · GWE
Nicolet Biomedical Instruments
Neurology · 61d
Cleared May 23, 1979
CENTRIFICHEM FILTER CALIBRATION SET
K790643 · JIW
Union Carbide Corp.
Chemistry · 54d
Cleared May 23, 1979
HELENA QUIPLATE SYSTEM
K790646 · JZQ
Helena Laboratories
Immunology · 54d
Cleared May 23, 1979
VENOUS PRESSURE MONITOR, MF 35 LF
K790668 · KRK
Deco Medical, Inc.
Cardiovascular · 47d
Cleared May 23, 1979
ESTRADIOL RIA KIT
K790679 · CHP
Serono Laboratories, Inc.
Chemistry · 44d
Cleared May 23, 1979
ENZYMATIC DETERMINATION
K790724 · CHH
Sigma Chemical Co.
Chemistry · 40d
Cleared May 23, 1979
REAGENT SYSTEM #350HDL, SIGMA PROCEDURE
K790760 · CHH
Sigma Chemical Co.
Chemistry · 36d
Cleared May 23, 1979
IMMU-TEK AUTOMATIC CENTRIFUGE
K790767 · KSN
Dade, Baxter Travenol Diagnostics, Inc.
Hematology · 34d
Cleared May 23, 1979
WAKO CHOLESTEROL TEST
K790768 · CHH
Wako Intl., Inc.
Chemistry · 34d