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
148513–148536 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 08, 1985
GEN. DIAG. CHROMOSTRATE PLASMINOGEN ASSAY
K850410 · DDX
Warner-Lambert Co.
Immunology · 93d
Cleared May 08, 1985
GEN. DIAG. CHROMOSTRATE ALPHA-2 ANTIPLASMIN ASSAY
K850411 · LGP
Warner-Lambert Co.
Immunology · 93d
Cleared May 08, 1985
GEN. DIAG. CHROMOSTRATE ANTITHROMBIN III ASSAY
K850412 · JBQ
Warner-Lambert Co.
Hematology · 93d
Cleared May 08, 1985
GENERAL DIAG. CHROMOSTRATE HEPARIN ASSAY
K850486 · KFF
Warner-Lambert Co.
Hematology · 90d
Cleared May 08, 1985
ABCO SUCTION CANISTER
K851316 · KDQ
Abco Dealers, Inc.
General Hospital · 36d
Cleared May 08, 1985
IMED GRAVISET INTRAVASCULAR ADMIN. SET
K851360 · FRN
Imed Corp.
General Hospital · 34d
Cleared May 08, 1985
MEDICAL/SURGICAL SUCTION SYSTEM
K851384 · GCX
Puritan Bennett Corp.
General Hospital · 29d
Cleared May 08, 1985
IVAC MODEL 580 GENER. USE VOLUMETRIC INFUSION PUMP
K851447 · FRN
Y
General Hospital · 44d
Cleared May 08, 1985
MERIVAARA ELECTRIC HOSPITAL BED & ACCESSORIES
K851551 · FNL
Daun International, Inc.
General Hospital · 22d
Cleared May 08, 1985
MERIVAARA HOSPITAL BED
K851552 · FNJ
Daun International, Inc.
General Hospital · 22d
Cleared May 08, 1985
BILE ESCULIN AZIDE AGAR
K851577 · JSI
Preferred Micro-Media
Microbiology · 22d
Cleared May 08, 1985
BILE ESCULIN AGAR
K851578 · JSI
Preferred Micro-Media
Microbiology · 22d
Cleared May 08, 1985
CHOCOLATE MUELLER HINTON AGAR
K851579 · JTY
Preferred Micro-Media
Microbiology · 22d
Cleared May 08, 1985
TRICHOMONAS BROTH (KUPFORBERG
K851599 · JSJ
Preferred Micro-Media
Microbiology · 22d
Cleared May 08, 1985
TRYPTIC SOY AGAR W/5% SHEEP BLOOD
K851600 · KZI
Preferred Micro-Media
Microbiology · 22d
Cleared May 08, 1985
TRYPTIC SOY BROTH
K851601 · JSG
Preferred Micro-Media
Microbiology · 22d
Cleared May 08, 1985
UREA AGAR
K851602 · JSH
Preferred Micro-Media
Microbiology · 22d
Cleared May 08, 1985
XYLOSE LYSINE DESOXYCHOLATE AGAR
K851603 · JSI
Preferred Micro-Media
Microbiology · 22d
Cleared May 07, 1985
ESCOTEK-EST 221 VACUUM UNIT
K844387 · IPF
Nor-Am Patient Care Products, Inc.
Physical Medicine · 175d
Cleared May 07, 1985
ESCOTEK EST 220 INTERFERENCE THERAPY UNIT
K844388 · IPF
Nor-Am Patient Care Products, Inc.
Physical Medicine · 175d
Cleared May 07, 1985
ESCOTEK EST 210, HIGH VOLTAGE ELECTRO GALVANIC STI
K844389 · IPF
Nor-Am Patient Care Products, Inc.
Physical Medicine · 175d
Cleared May 07, 1985
ESCOTEK-EST 204 MULTI STIM
K844390 · IPF
Nor-Am Patient Care Products, Inc.
Physical Medicine · 175d
Cleared May 07, 1985
HYPAFIX POST OPERATIVE DRESSING
K850282 · NAD
Smith & Nephew, Inc.
General & Plastic Surgery · 104d
Cleared May 07, 1985
SINUS AC-POWERED MUSCLE STIMULATOR
K850453 · IPF
Zimmer Elektromedizin GmbH
Physical Medicine · 90d