15 results
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17ms
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Sources: EU EUDAMED, US FDA
INTERPULSE MEMBRANE OXYGENATION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
Low Speed Saliva Ejector Valve/Head/Filter assembly
FDA UDI
Vista Dental·10818207021639·
LEONE SPA
FDA UDI
LEONE SPA·08033707066095·ELASTIC COTTON THREAD STRONG
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221110053·3M™ Unitek™ Single-Ended Ligature Director, 803...
TruTorq Adaptor Sterile, Single Use
FDA UDI
Eca Medical Instruments·00857676008294·
AESCULAP- MEITHKE PROGAV PROGRAMMABLE SHUNT SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
Pantheon IBFD
FDA 510(k)
FDA Class 2
·Orthopedic
PROGAV®
FDA Adverse Event
Injury
·CHRISTOPH MIETHKE GMBH & CO. KG·Product code JXG·January 3, 2018
PFC*SIGMA TC3 INS17.5MM,SZ2
FDA Adverse Event
Injury
·1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC·Product code JWH·May 9, 2014
CONSTELLATION VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·October 19, 2012
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·August 17, 2010
Nuclear Gamma Cameras (ADAC Vertex Classic, ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60) Philips Medical Systems, Cleveland, OH
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·May 20, 2015
Nuclear gamma cameras (ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60 & ADAC CARDIO C60) Nuclear gamma cameras intended to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·May 20, 2015
Nuclear gamma cameras (ADAC Vertex Plus, ADAC Solus, ADAC Vertex V60 & ADAC Vertex Classic) Philips Medical System, Cleveland, OH 44143. Used to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·May 7, 2014
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012