Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACE Header, End Cap, Epicardial Patch Lead and Upsizing Sleeve

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·MynxGrip, Mynx Ace, and Mynx Control Vascular Closure Device (VCD)

Medline ReNewal Reprocessed Harmonic ACE+7 Shears

FDA 510(k)

FDA Unclassified ·Unknown

ACETAMINOPHEN ASSAY (ACE), CATALOGUE NUMBER 503-10

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DEPUY ACE AIM(R) TITANIUM SUPRACONDYLAR NAIL

FDA 510(k)

FDA Class 2 ·Orthopedic

STRATUS N-ACE (NAPA) FLUOROMETRIC ENZYME/IMMUNO.

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ACE CANNULATED SELF-TAPPING CORTICAL BONE SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

CK 5000 SERIES, ACE BANDAGE/ESMARK BANDAGE

FDA 510(k)

HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE

FDA 510(k)

FDA Unclassified ·Unknown

SALICYLATE ASSAY (ACE), CATALOGUE NUMBER 501-71

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Micro Ace Gold Advanced Micro Access System

FDA 510(k)

FDA Class 2 ·Cardiovascular

5MM/8MM HARMONIC ACE(TM) CURVED SHEARS, DISPOSABLE HARMONIC ACE(TM) INSERT, DISPOSABLE HARMONIC(TM) CURVED SHEARS INSERT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HARMONIC ACE+ SHEARS 23 CM LENGTH WITH ADVANCED HEMOSTASIS, HARMONIC ACE + LAPAROSCOPIC SHEARS 36 CM LENGTH WITH ADVANCE

FDA 510(k)

FDA Unclassified ·Unknown

HYCOGEL

Basic UDI-DI

EU MDD · Eu Md Class 3 ·MEDI J Co., Ltd·1 device

HYCOGEL

Basic UDI-DI

EU MDD · Eu Md Class 3 ·MEDI J Co., Ltd·1 device

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACE HEADER/TRANSVENE DEFIBRILLATION LEAD/LEAD END PIN CAP/UPSIZING SLEEVE

PARAMAX ALKALINE PHOSPHATASE REAGENT-

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ALP REAGENT SET, ALKALINE PHOSPHATASE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GILCHEM ALP REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ALKALINE PHOSPHATASE (AP) FOR CONT. FLOW INSTRU.

FDA 510(k)

FDA Class 2 ·Clinical Chemistry