FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
171265–171288 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 19, 1978
HEMATOLOGY SLIDE STAINER
K780637 · KPA
A. J. P. Scientific, Inc.
Hematology · 32d
Cleared May 19, 1978
CSS-60 DIGITAL HEART RATE METER
K780702 · DRT
Burdick Corp.
Cardiovascular · 24d
Cleared May 19, 1978
INFUSION PUMP-MODEL 2616
K780705 · FRN
Harvard Apparatus, Inc.
General Hospital · 24d
Cleared May 19, 1978
NEUROLOGICAL SCREENING STIMULATOR M 3623
K780758 · GZB
Medtronic Vascular
Neurology · 11d
Cleared May 19, 1978
MODEL 902 STAND
K780759 · FSH
Applied Medical Research
General & Plastic Surgery · 11d
Cleared May 19, 1978
ECONO-FLOAT WATER FLOTATION MATTRESS
K780779 · IKY
Jefferson Industries, Inc.
General Hospital · 8d