TEG 6s Hemostasis System

FDA 510(k)

FDA Class 2 ·Hematology

IntelliSpace Radiology

FDA 510(k)

FDA Class 2 ·Radiology

Vario-Cup System

FDA 510(k)

FDA Class 2 ·Orthopedic

MICROVASIVE ZERO TIP AIRWAY RETRIEVAL BASKET, MODELS M00513200 AND M00513210

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

CRE PULMONARY BALLOON DILATATION CATHETER, MODELS K00550300, M00550310, M00550320, M00550330, M00550340, M00550350

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Premium Teeth Resin

FDA 510(k)

FDA Class 2 ·Dental

ATTUNE™ Revision Hinge Knee

FDA 510(k)

FDA Class 2 ·Orthopedic

DUALFLEX RX ERCP CANNULA, MODELS 4681, 4682

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

P.004 NC ANATOMIC ABUTMENTS

FDA 510(k)

FDA Class 2 ·Dental

ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, ENDOVIVE STANDARD PROFILE BALLOON REPLACEMENT, MODELS 6520, 6521, 6220

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ENDOVIVE INITIAL PLACEMENT GASTROSTOMY KIT; ENDOVIVE LOW PROFILE BUTTON REPLACEMENT GASTROSTOMY TUBE; SECURI-T INITIAL P

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, PEG SAFETY KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

P.004 RC CARES TITANIUM AND CERAMIC ABUTMENTS

FDA 510(k)

FDA Class 2 ·Dental

ARTICUL/EZE Ceramic Heads

FDA 510(k)

FDA Class 2 ·Orthopedic

ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, MODELS 6520 & 6521

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

P.004 ABUTMENTS

FDA 510(k)

FDA Class 2 ·Dental

LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface

FDA 510(k)

FDA Class 2 ·Orthopedic

SP-CL Hip Stem and LCU Hip System

FDA 510(k)

FDA Class 2 ·Orthopedic

RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology