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ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH COATING

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

IMPACT-20

FDA UDI
Denplus Inc·D8451031301·IMPACT-20, SPL, 11.3 kg

Cardiovascular Procedure Kit

FDA UDI
Terumo Cardiovascular Systems Corporation·00699753510036·

Response 5.5/6.0 Cannulated Screw System

FDA UDI
ORTHOPEDIATRICS CORP.·00840194422369·5.5/6.0 Cannulated Reduction Screw Instrument T...

Response 5.5/6.0 Cannulated Screw System

FDA UDI
ORTHOPEDIATRICS CORP.·00840194422345·5.5/6.0 Cannulated Polyaxial Reduction Screw Ca...

Response 5.5/6.0 Cannulated Screw System

FDA UDI
ORTHOPEDIATRICS CORP.·00840194422376·5.5/6.0 Cannulated Reduction Screw Instrument T...

Response 5.5/6.0 Cannulated Screw System

FDA UDI
ORTHOPEDIATRICS CORP.·00840194417136·5.5/6.0 Cannulated Screw Instrument Tray 2

OP Response Spine System

FDA UDI
ORTHOPEDIATRICS CORP.·00840194455817·5.5/6.0 Closed Instrument Tray 2

Response 5.5/6.0

FDA UDI
ORTHOPEDIATRICS CORP.·00840194418294·5.5/6.0 SI Fixation Caddy

Response 5.5/6.0

FDA UDI
ORTHOPEDIATRICS CORP.·00840194418461·5.5/6.0 SI Fixation Implant Caddy

Response 5.5/6.0 Cannulated Screw System

FDA UDI
ORTHOPEDIATRICS CORP.·00840194417129·5.5/6.0 Cannulated Screw Instrument Tray 1

OP Response Spine System

FDA UDI
ORTHOPEDIATRICS CORP.·00840194422383·5.5/6.0 Closed Screw Caddy 1

Response 5.5/6.0 Cannulated Screw System

FDA UDI
ORTHOPEDIATRICS CORP.·00840194422338·5.5/6.0 Cannulated Screw Instrument Tray 3

OP Response Spine System

FDA UDI
ORTHOPEDIATRICS CORP.·00840194455800·5.5/6.0 Closed Instrument Tray 1

Response 5.5/6.0 Cannulated Screw System

FDA UDI
ORTHOPEDIATRICS CORP.·00840194417105·5.5/6.0 Cannulated Polyaxial Screw Caddy 1

UNICONDYLAR FEMORAL COMPONENT

FDA 510(k)
FDA Class 2 ·Orthopedic

UNI-T SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

Trulink

FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522127359·SAMPLE LINE,AGENT,W/SAMPLING TEE,10',50/BX

Optimotion Blue CR HCCR Total Knee System

FDA UDI
OPTIMOTION IMPLANTS LLC·B6961014P0313010·CR Tibial Insert, UHMWPE + Vitamin E, Size 3, ...

ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code MCX·April 2, 2013