17 results
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34ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GRADIA GUM
FDA 510(k)
FDA Class 2
·Dental
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033808·Baltic Denture System BDLoad BDLoad Ln6 PLSEbi...
Acid Etchant
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746071003·ADHESIVE ACID ETCHANT GEL SYRINGE TIP 20/PK
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0330080·Rocker, Hinged, Locking
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00811801037528·Straight LLIF Distractor, 8 Deg Lordotic, 9mm
TAKE 1
FDA 510(k)
FDA Class 2
·Dental
SLEEPBITE
FDA 510(k)
FDA Class 2
·Dental
KYPHX HV-R BONE CEMENT
FDA Adverse Event
Injury
·KYPHON, INC.·Product code NDN·June 23, 2006
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 8, 2024
KYPHX HV-R BONE CEMENT
FDA Adverse Event
Injury
·KYPHON, INC.·Product code NDN·June 20, 2006
NO CODE AVAILABLE
FDA Adverse Event
Injury
·SYNTHES USA·Product code GXN·March 8, 2016
UNKNOWN DEPUY SZ 5 12.5MM STAB TIB INSERT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·April 3, 2013
ASR ACETABULAR CUPS 56
FDA Adverse Event
Injury
·DEPUY INT'L., LTD.·Product code KWA·March 17, 2011
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·April 24, 2008
PLATE, CRANIOPLASTY, PREFORMED, ALTERABLE
FDA Adverse Event
Injury
·SYNTHES USA·Product code GWO·June 21, 2016
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