14 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ABX MICROS CRP 200, OPTION IM
FDA 510(k)
FDA Class 2
·Hematology
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00533081·
LEONE SPA
FDA UDI
LEONE SPA·08033707065821·EXTRAORAL ELASTICS 1/4" 8 oz
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809842784·FOR MEN 30-40 MM HG KNEE HIGH CLOSED TOE LARGE-...
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, IR1DAI, IR1DB1, IR1DD1
FDA 510(k)
FDA Class 2
·General Hospital
VENTLAB HYPERINFLATION BAG SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
PASS LP
FDA Adverse Event
Injury
·MEDICREA TECHNOLOGIES·Product code MNI·April 17, 2013
PASS LP
FDA Adverse Event
Injury
·MEDICREA·Product code MNI·April 17, 2013
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 11, 2013
PERFIX PLUG
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·May 23, 2008
SIGMA 300 SR
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code DXY·April 13, 2011
PASS LP - LIAPASS
FDA Adverse Event
Injury
·MEDICREA TECHNOLOGIES·Product code MNI·March 29, 2013
Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 10300361301028 (Package) - Product Usage: A gel pad for use on woman s areola during an ultrasound examination. Its primary purpose is for patient comfort over the loose gel and helps with nipple location during the scan, making the areola location easier to identify.
FDA Enforcement
Class II
·Terminated·Pharmaceutical Innovations, Inc.·August 26, 2020
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