MODEL EV4543 MINIATURE TEMPORARY CARDIAC PACEMAKER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENROUTE Transcarotid Neuroprotection System

FDA 510(k)

FDA Class 2 ·Cardiovascular

CYNERGY MODEL 184

FDA 510(k)

FDA Class 2 ·Cardiovascular

RX ACCUNET LP EMBOLIC PROTECTION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

WIRION

FDA 510(k)

FDA Class 2 ·Cardiovascular

EXTERNAL DEMAND PACEMAKER

FDA 510(k)

FDA Class 2 ·Cardiovascular

SPIDERFX EMBOLIC PROTECTION DEVICE

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO: RX ACCUNET EMBOLIC PROTECTION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V

FDA 510(k)

FDA Class 2 ·Cardiovascular

ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

RX ACCUNET Embolic Protection System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Precision Montage and Precision Montage MRI Spinal Cord Stimulator System

Neodent

FDA UDI

JJGC Indústria e Comércio de Materiais Dentários S/A.·07899878059813·GM ZYGOMA-S IMPLANT

OrthoMedFlex

FDA UDI

ORTHOMEDFLEX LLC·M7161111621380·Cemented Stem, Standard Offset, Size 1

OT-F2 / OT-F3 Prosthetics

FDA UDI

OT medical GmbH·EOTM0225090055101·Creative Line Abutment for dental Implant, made...

Hexagon

FDA UDI

ACE SURGICAL SUPPLY CO., INC.·00614950015863·RP Contoured Healing Abutment, D 6.5 mm, H 3.0 mm

Infinity External Hex System

FDA UDI

ACE SURGICAL SUPPLY CO., INC.·00614950004003·SCREW 3MM FOR INTERNAL BALL ABUTMENT 4MM SYSTEM...

Evolve

FDA UDI

SIGNATURE ORTHOPAEDICS PTY LTD·09348215002886·

SenSura

FDA UDI

Coloplast A/S·05701780220873·