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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
144961–144984 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 07, 1986
TELESCOPE PROTECTION TUBE
K860265 · KOD
R. J. Ltd., Ind.
Gastroenterology & Urology · 70d
Cleared Apr 07, 1986
DIAMATIC, AUTOMATIC INSULIN INJECTOR
K860284 · KZH
Ulster Scientific, Inc.
General Hospital · 69d
Cleared Apr 07, 1986
ACTHK-PR RIA KIT
K860311 · CKG
Compagnie Oris Industrie, S.A.
Chemistry · 69d
Cleared Apr 07, 1986
CLINISET INFUSION SET
K860322 · FPA
Zimmar Consulting , Ltd.
General Hospital · 68d
Cleared Apr 07, 1986
HGM, INC. LASERCATH (STERILE)
K860357 · LNK
Hgm, Inc.
Gastroenterology & Urology · 67d
Cleared Apr 07, 1986
CHALLENGER HOT BIOPSY FORCEPS
K860366 · KNS
Microvasive
Gastroenterology & Urology · 63d
Cleared Apr 07, 1986
FLAME PHOTOMETER STANDARD
K860501 · JLJ
Medical Specialties, Inc.
Chemistry · 55d
Cleared Apr 07, 1986
INFLATOR/DEFLATOR PISTON SYRINGE
K860589 · KNT
Microvasive
Gastroenterology & Urology · 47d
Cleared Apr 07, 1986
TRANSFER SET
K860595 · LHI
Migada, Ltd.
General Hospital · 47d
Cleared Apr 07, 1986
ALPHA-AMYLASE TEST
K860665 · JFJ
Sclavo, Inc.
Chemistry · 42d
Cleared Apr 07, 1986
ION-SPECIFIC ELECTRODE, CHLORIDE
K860668 · CGZ
Em Diagnostic Systems, Inc.
Chemistry · 42d
Cleared Apr 07, 1986
CREATINE KINASE, N-ACETYL-L-CYSTIENE
K860669 · CGS
Em Diagnostic Systems, Inc.
Chemistry · 42d
Cleared Apr 07, 1986
DRS-4 DIALYZER REPROCESSING SYSTEM
K860674 · LIF
Seratronics, Inc.
Gastroenterology & Urology · 42d
Cleared Apr 07, 1986
COMPANION 2800 VOLUME VENTILATOR REMOT ALARM
K860675 · CBK
Puritan Bennett Corp.
Anesthesiology · 42d
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