13 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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REGENEREX ULTRA POROUS CONSTRUCT-FEMORAL AND TIBIAL KNEE AUGMENTS
FDA 510(k)
FDA Class 2
·Orthopedic
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809843804·FOR MEN 30-40 MM HG KNEE HIGH CLOSED TOE EXTRA ...
CERAMENT® G
FDA UDI
Bone Support AB·07350055430523·CERAMENT G is an implantable bone void filler (...
KFA-127 KNEE, FOOT AND ANKLE ARRAY
FDA 510(k)
FDA Class 2
·Radiology
AUROFLUID PLUS
FDA 510(k)
FDA Class 2
·Dental
ESON 2 NASAL MASK
FDA Adverse Event
Injury
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·August 14, 2019
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 6, 2025
IBP ELB INT. ULNA LRG RGT LNG STM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JDC·June 24, 2016
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM INC.·Product code MDS·April 11, 2013
HOMECHOICE CYCLER-REFURBISHED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·May 28, 2008
ATTAIN STARFIX
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 13, 2011
Advisor Vital Signs Monitor model 9200, catalog number 925474325. Item Description 9200II 3LD/RP/SO/O2/IP/TP BMDD. The basic monitoring package includes ECG (3 lead / 5 lead), impedance respiration, non-invasive blood pressure, pulse oximetry, two invasive blood pressures, and tow temperature channels. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals.
FDA Recall
Terminated
·Smiths Medical PM, Inc.·Product code DPS·January 5, 2005
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