17 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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CALYSTO SERIES IV PATIENT CARE MONITORS AND CENTRAL STATION AND ECG MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
CTXA Hip Extended Reference Data
FDA UDI
MINDWAYS SOFTWARE, INC.·B052DICTXAHIPEXTDB0·The CTXA Hip Extended Reference Data is an acce...
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091033030·Baltic Denture System BDLoad Lm6 PLSEbil2DFl C4...
Mixing Tip 6.5T 48pk
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172019279·Dental material mixing nozzle, non-sterile
Mixing Tip 6.5T 48-Pack
FDA UDI
DEN-MAT HOLDINGS, LLC·00359883002527·Dental material mixing nozzle, non-sterile
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0130300·Wrench, Derotation, Double Ended
Kalitec Universal Instruments
FDA UDI
Kalitec Direct LLC·B07301K0380300·Handle, Threaded In Line, Plastic M8
ALPHATEC
FDA Adverse Event
ALPHATEC MFG INC. AKA NEXMED INC·Product code HWC·February 26, 2004
Omnicurve
FDA UDI
STRYKER CORPORATION·07613327638257·10G 30MM EXTRA LEVEL
LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET
FDA 510(k)
FDA Class 2
·Hematology
DEMETECH POLYESTER NONABSORBABLE SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWQ·April 3, 2013
UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·March 29, 2011
UNKNOWN CERAMIC ON CERAMIC HIP
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS CORK·Product code LZO·April 22, 2008
SYNERGY
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·February 2, 2015
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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024