18 results
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19ms
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Sources: EU EUDAMED, US FDA
SENSOMAT
FDA 510(k)
FDA Class 2
·Anesthesiology
Needle aspiration and injection
FDA UDI
KATENA PRODUCTS, INC.·00841668113608·PERIBULBAR NEEDLE 25GA 22MM
Rampart-O
FDA UDI
SPINEOLOGY INC.·M7403803014·Asm, Rampart-O
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450270134·
Rampart-O
FDA UDI
SPINEOLOGY INC.·M7402803014·Rampart-O
ATLAS SPEEDER HEAD/CERVICAL COIL, MODEL MJAH-137A
FDA 510(k)
FDA Class 2
·Radiology
SOMATOM EMOTION MS
FDA 510(k)
FDA Class 2
·Radiology
LOCKING SCREW, 3.5 X 18MM
FDA Adverse Event
Malfunction
·ASCENSION ORTHOPEDICS·Product code HRS·March 17, 2014
VISIFLEX
FDA Adverse Event
Injury
·ENDOLOGIX·Product code MIH·November 30, 2015
ADVIA CENTAUR XP
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJE·May 9, 2014
HEARTSTART ONSITE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·October 19, 2012
COBAS E411 DISK SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code DHA·August 17, 2010
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 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, 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
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
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
Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018