11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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WILLI GELLER CREATION ZI PORCELAIN
FDA 510(k)
FDA Class 2
·Dental
Raw Surgical Corporation
FDA UDI
RAW SURGICAL CORPORATION·G508RSC40432010·LOVE-GRUENWALD PITUITARY RONGEUR FORCEPS, Cup s...
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0430210·Sagittal Bender, Double Ended Right
CARDIOFOCUS DIODE LASER SYSTEM, MODELS 60R, 60NR, 30NR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
STEALTHSTATION TREATMENT GUIDANCE PLATFORM
FDA 510(k)
FDA Class 2
·Neurology
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·April 9, 2013
EASYPUMP
FDA Adverse Event
Malfunction
·I-FLOW CORPORATION·Product code MEB·February 24, 2011
VITALITY DR
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
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
Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018