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
144385–144408 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 07, 1986
CAPD DISCONNECT SYSTEM 5C4182, 5C4183, 5C4186
K860700 · KDJ
Travenol Laboratories, S.A.
Gastroenterology & Urology · 41d
Cleared Apr 07, 1986
G.T. (GAMMA-GLUTAMYL TRANSFERASE) REAGENT
K860723 · JPZ
Trace Scientific , Ltd.
Chemistry · 40d
Cleared Apr 07, 1986
ENZYMATIC GLUCOSE REAGENT (HEXOKINASE)
K860724 · CFR
Trace Scientific , Ltd.
Chemistry · 40d
Cleared Apr 07, 1986
AST(GOT) (ASPARTATE AMINOTRANSFERASE) REAGENT
K860725 · CIT
Trace Scientific , Ltd.
Chemistry · 40d
Cleared Apr 07, 1986
ALT(GPT) (ALANINE AMINOTRANSFERASE) REAGENT
K860727 · CKA
Trace Scientific , Ltd.
Chemistry · 40d
Cleared Apr 07, 1986
L D H-L (LACTIC DEHYDROGENASE) REAGENT
K860728 · CFJ
Trace Scientific , Ltd.
Chemistry · 40d
Cleared Apr 07, 1986
LDH-P (LACTIC DEHYDROGENASE) REAGENT
K860729 · CFJ
Trace Scientific , Ltd.
Chemistry · 40d
Cleared Apr 07, 1986
ENZYMATIC TRIGLYCERIDES REAGENT (SINGLE VIAL)
K860730 · CDT
Trace Scientific , Ltd.
Chemistry · 40d
Cleared Apr 07, 1986
TRIGLYCERIDES REAGENT (INT, COLORIMETRIC)
K860731 · JGY
Trace Scientific , Ltd.
Chemistry · 40d
Cleared Apr 07, 1986
AUTO SYRINGE MICRO VOL EXT SET W/AIR VENT FILTER
K860746 · FPB
Travenol Laboratories, S.A.
General Hospital · 39d
Cleared Apr 07, 1986
EMDS ENZYME VERIFIER, LEVELS I & II
K860764 · JJT
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Apr 07, 1986
EMDS CHEMISTRY CALIBRATORS, LEVELS I & II
K860765 · JIX
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Apr 07, 1986
SAMPLE MANIFOLD HOLDER
K860889 · FMG
R. Bell
General Hospital · 28d
Cleared Apr 07, 1986
EASY-TEST URIC ACID (URIC), #67516/93
K860916 · KNK
Em Diagnostic Systems, Inc.
Chemistry · 27d
Cleared Apr 07, 1986
EASY-TEST TOTAL PROTEIN (TP), #67513/93
K860917 · CEK
Em Diagnostic Systems, Inc.
Chemistry · 27d
Cleared Apr 07, 1986
GAMBRO FIBER HEMOFILTERS FH 22/66 DISPOS TUBE SETS
K860938 · KDI
Gambro, Inc.
Gastroenterology & Urology · 26d
Cleared Apr 07, 1986
GILFORD UNIQUAL NORMAL CONTROL SERUM - ASSAYED
K861068 · JJY
Ciba Corning Diagnostics Corp.
Chemistry · 18d
Cleared Apr 07, 1986
CELLEMATICS VIRAL/CHLAMYDAL TRANSPORT PACK(MODIFI)
K861080 · JSM
Difco Laboratories, Inc.
Microbiology · 17d
Cleared Apr 07, 1986
AVL MODEL 983 ELECTROLYTE ANALYZER
K861087 · JGS
Avl Scientific Corp.
Chemistry · 17d
Cleared Apr 07, 1986
FRESENIUS HEMOFLOW F80 DIALYZER
K861106 · KDI
Seratronics, Inc.
Gastroenterology & Urology · 14d
Cleared Apr 07, 1986
KODAK AUTOMIXER II
K861225 · IXW
Eastman Kodak Company
Radiology · 6d
Cleared Apr 04, 1986
EMPEROR 5/20 & STD, C.C, ORTHO, PSP REFIT, PERISEA
K853094 · EBI
Psp Dental Co., Ltd.
Dental · 255d
Cleared Apr 04, 1986
HONEYWELL ELECTRONIC VENTILATOR EV-A
K853501 · CBK
Honeywell, Inc.
Anesthesiology · 227d
Cleared Apr 04, 1986
VES-TEC/VES-MATIC
K854223 · CKB
Marvic Interpharma, Inc.
Hematology · 168d