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
145945–145968 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 25, 1985
OMIDERM WOUND & BURN DRESSING
K851885 · FRO
Biosystems Assoc.
General & Plastic Surgery · 209d
Cleared Nov 25, 1985
POROCOAT SYNATOMIC UNICONDYLAR KNEE
K853020 · HSX
Depuy, Inc.
Orthopedic · 130d
Cleared Nov 25, 1985
P.C.A. UNIVERSAL ACETABULAR COMPONENT SYSTEM
K853886 · JDI
Howmedica Corp.
Orthopedic · 67d
Cleared Nov 25, 1985
EGNELL UNIVERSAL SUCTION PUMP
K853909 · BTA
Egnell, Inc.
General & Plastic Surgery · 66d
Cleared Nov 25, 1985
EGNELL COMPACT SUCTION PUMP
K853917 · BTA
Egnell, Inc.
General & Plastic Surgery · 63d
Cleared Nov 25, 1985
PLASTELAST AND/OR ELASTOPLASTE
K854006 · KGX
Cp Medical
General & Plastic Surgery · 56d
Cleared Nov 25, 1985
BIOPSY TRAY I & II
K854095 · LRO
North Coast Medi-Tek
General & Plastic Surgery · 49d
Cleared Nov 25, 1985
IN-VITRO TEST FOR THE DETERMINATION OF GLUCOSE
K854177 · CGA
Clinical Data, Inc.
Chemistry · 41d
Cleared Nov 25, 1985
IN-VITRO TEST FOR THE DETERMINATION OF CREATININE
K854178 · CGX
Clinical Data, Inc.
Chemistry · 41d
Cleared Nov 25, 1985
IN-VITRO TEST FOR THE DETERMINATION OF CHOLESTEROL
K854179 · CHH
Clinical Data, Inc.
Chemistry · 41d
Cleared Nov 25, 1985
IN-VITRO TEST DETERMINATION TOTAL BILIRUBIN
K854180 · CIG
Clinical Data, Inc.
Chemistry · 41d
Cleared Nov 25, 1985
IN-VITRO TEST DETERMINATION OF ALBUMIN
K854181 · CIX
Clinical Data, Inc.
Chemistry · 41d
Cleared Nov 25, 1985
IN-VITRO TEST DETERMINATION OF TRIALYCERIDE
K854182 · CDT
Clinical Data, Inc.
Chemistry · 41d
Cleared Nov 25, 1985
IN-VITRO TEST DETERMINATION OF URIC ACID
K854185 · KNK
Clinical Data, Inc.
Chemistry · 41d
Cleared Nov 25, 1985
IN-VITRO TEST DETERMINATION OF SGOT (AST)
K854187 · CIS
Clinical Data, Inc.
Chemistry · 41d
Cleared Nov 25, 1985
IN VITRO TEST DETERMINATION OF INORGANIC PHOSPHORO
K854188 · CEO
Clinical Data, Inc.
Chemistry · 41d
Cleared Nov 25, 1985
CANTROL SPINAL FLUID CONTROL
K854190 · DFI
Canyon Diagnostics, Inc.
Immunology · 41d
Cleared Nov 25, 1985
DIESSE CRP TEST KIT
K854221 · DCK
Marvic Interpharma, Inc.
Immunology · 38d
Cleared Nov 25, 1985
ENZYMATIC TRIGLYCERIDES GPO-GRINDER METHOD
K854366 · CDT
American Monitor Corp.
Chemistry · 27d
Cleared Nov 25, 1985
TDX CORTISOL
K854419 · JFT
Abbott Laboratories
Chemistry · 21d
Cleared Nov 25, 1985
TDX R OPIATES
K854421 · DJG
Abbott Laboratories
Chemistry · 21d
Cleared Nov 25, 1985
SPECTRA 724
K854498 · FTC
Daavlin Co.
General & Plastic Surgery · 13d
Cleared Nov 25, 1985
ALT(OPTIMIZED) REAGENT
K854502 · CKA
Sigma Diagnostics, Inc.
Chemistry · 13d
Cleared Nov 25, 1985
AST(OPTIMIZED) REAGENT
K854503 · CIT
Sigma Diagnostics, Inc.
Chemistry · 13d