ACCU-SPACE ABSORBABLE SEEDING SPACERS

FDA 510(k)

FDA Class 2 ·Radiology

INNOFLUOR DIGOXIN CALIBRATOR SET

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CMI VELVET TOUCH VACUUM EXTRACTOR

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

PELVX RING, PELVX RING WITH SUPPORT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SLEEP APP

FDA 510(k)

FDA Class 2 ·Dental

BK-N SEALING CAP

FDA 510(k)

FDA Class 2 ·Cardiovascular

KILEJIAN CIRCUMCISION TEMPLATE [THE DOME]

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Coconut Hybrid

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

HEARTHWATCH III(TM)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BioNourish Lubricant

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE

FDA 510(k)

FDA Class 2 ·Cardiovascular

A1-A,ABP,B,MBP, LEAD CONNECTORS; PEH ADAPTER SLEEVE

FDA 510(k)

FDA Class 2 ·Cardiovascular

MULTICHANNEL RECORDING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACUMED CANNULATED SCREW SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

AFFIRM ONE-STEP PROFESSIONAL PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACUMED SCAPULA CONGRUENT BONE PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

AUDICOR CPAM WITH SDB (SINGLE SENSOR)

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACTIWATCH-SCORE

FDA 510(k)

FDA Class 2 ·Neurology

MODIFIED ACCUFLUOR PHENOBARBITAL REAGENT & CALIBRA

FDA 510(k)

FDA Class 2 ·Clinical Toxicology