16 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ZIMMER ORTHO GUIDANCE SYSTEMS- KNEE INSTRUMENTS
FDA 510(k)
FDA Class 2
·Neurology
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091033011·Baltic Denture System BDLoad ↓ Sw6 PLSEum6DFs C...
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0330150·Coronal Bender, Left
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0130110·Segmental Rod Reducer, Slim, Assembly
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0330160·Coronal Bender, Right
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710620330110·Quad Channel Met-Traverse, 33mm x 11mm
OSMONICS SOLUTION DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SELF ETCH BONDING PRIMER
FDA 510(k)
FDA Class 2
·Dental
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 3, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·March 29, 2011
COOK TPN CATHETER REPAIR SET
FDA Adverse Event
Malfunction
·COOK INCORPORATED·Product code DQY·April 22, 2008
NAIL, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code JDS·July 25, 2016
NAIL, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code JDS·July 25, 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
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018