PICA WHOLE-BODY MRI SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

SIGNET DXIS DIRECT X-RAY IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

PHILIPS HERCEPTEST DIGITAL SCORE

FDA 510(k)

FDA Class 2 ·Hematology

RIGIDFIX BIOCRYL 2.7MM BTB (210815), FEMORAL 3.3MM ST (210816), AND TIBIAL 3.3MM ST (210817) CROSS PIN KITS

FDA 510(k)

FDA Class 2 ·Orthopedic

PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip; RIGIDLOOP™ BTB; RIGIDLOOP™ Suture Loop

FDA 510(k)

FDA Class 2 ·Orthopedic

POLY PISTON

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SHEA LOCKING BAIL PROSTHESIS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

INCUDOSTAPEDIAL JOINT

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

HAPES MALLEABLE INCUS STAPES

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

TEF/PLATINUM PISTON

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

TREBAY PARTIAL RECTRANGULAR HEADS, MORETZ CAM, INCUS/STAPEDIAL JOINT & STRAIGHT INCUS STRUT

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

STAINLESS STEEL PISTONS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SMITH & NEPHEW OFF-CENTERED PORP

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

WEHRS INCUS AND INCUS-STAPES PROSTHESES

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

CAUSSE SPONGE BOAT

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MICROTEK PISTON & WIRE PROSTHESES

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MICROMEDICS S&T PARTIAL OSSICULAR REPLACEMENT PROSTHESIS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MISTEN MEDICAL PARTIAL OSSICULAR REPLACEMENT PROSTHESIS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat