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

Filters: Cleared only ×
176,076 results
172105–172128 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 25, 1978
SONOGRAF EDP REAL-TIME ADAPTER
K780578 · IYO
Foley, Lardner, Hollabaugh & Jacobs
Radiology · 45d
Cleared May 25, 1978
GYNESURG
K780587 · KNA
Polamedco, Inc.
Obstetrics & Gynecology · 44d
Cleared May 19, 1978
MICROCELL COUNTER MODEL CC-108
K780224 · GKL
Toa Medical Electronics USA, Inc.
Hematology · 105d
Cleared May 19, 1978
CARDIAC MINISCOPE & MINIGRAPH
K780297 · DRT
Arco Medical Products Co.
Cardiovascular · 87d
Cleared May 19, 1978
CARDIAC MINIGRAPH
K780307 · DPS
Arco Medical Products Co.
Cardiovascular · 87d
Cleared May 19, 1978
RP-510/RP-514 PARALLEL PLATE DIALYZERS
K780427 · FJG
Hospal Medical Corp.
Gastroenterology & Urology · 63d
Cleared May 19, 1978
SUTURELESS MYOCARDIAL PACING LEAD
K780446 · DTB
Medtronic Vascular
Cardiovascular · 60d
Cleared May 19, 1978
ELECTRODE TESTER
K780501 · KRC
Mg Medical Electronics
Cardiovascular · 52d
Cleared May 19, 1978
ULTRA ZYME PLUS AMYL 64982, GILFORD 3500
K780513 · CIJ
Harleco
Chemistry · 50d
Cleared May 19, 1978
ULTRACHEM CREATININE 64972, CENTRIFUCHEM
K780514 · CGX
Harleco
Chemistry · 50d
Cleared May 19, 1978
ULTRACHEM E-GLU, 300 SERIES CENTRIFUCHEM
K780515 · CFR
Harleco
Chemistry · 50d
Cleared May 19, 1978
ULTRACHEM ENZYMATIC CHOLESTEROL 65025
K780523 · CHH
Harleco
Chemistry · 49d
Cleared May 19, 1978
ULTRACHEM T-BILI 64971 GILFORD 3500
K780524 · CIG
Harleco
Chemistry · 49d
Cleared May 19, 1978
T-3 UPTAKE (SORBENT) KIT
K780525 · KHQ
Amersham Corp.
Chemistry · 49d
Cleared May 19, 1978
UREA NITROGEN (ENZYMATIC)
K780534 · CDQ
Macomb Chemical Co.
Chemistry · 46d
Cleared May 19, 1978
PRESSURE MODULES MODELS 1855 & 1856
K780541 · IKN
Life-Tech Instruments, Inc.
Neurology · 46d
Cleared May 19, 1978
ALFATEST
K780542 · LBR
Panmed, Inc.
Chemistry · 46d
Cleared May 19, 1978
COMP. CLIN. CHEM. CONTROL SERUM-DECISION
K780552 · JJY
Beckman Instruments, Inc.
Chemistry · 44d
Cleared May 19, 1978
COMP. CLIN. CHEM. REF. SERUM-BENCHMARK
K780553 · JIX
Beckman Instruments, Inc.
Chemistry · 44d
Cleared May 19, 1978
125-I LABELED HUMAN LUTEINIZING HORMONE
K780576 · CEP
Pcl-Ria, Inc.
Chemistry · 39d
Cleared May 19, 1978
PLATELETS/CU MM
K780577 · GKZ
Geometric Data, Div. Smithkline Corp.
Hematology · 39d
Cleared May 19, 1978
SUBCUPASS TUNNELING TOOL
K780579 · HAO
Medtronic Vascular
Neurology · 39d
Cleared May 19, 1978
AIRWAYS
K780601 · CAE
Abco Dealers, Inc.
Anesthesiology · 39d
Cleared May 19, 1978
REAGENT SET HDL CHOLESTEROL
K780635 · CHH
Boehringer Mannheim Corp.
Chemistry · 32d