12 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFICATION TO ALLOCLASSIC ZWEYMULLER SL OFFSET FEMORAL STEM
FDA 510(k)
FDA Class 2
·Orthopedic
UNKNOWN PFM-R DISTAL STEM
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code JDI·March 13, 2018
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033664·Baltic Denture System BDLoad BDLoad Mm6 PLSEbi...
DELFIA NEONATAL IRT KIT, MODEL A005-110
FDA 510(k)
FDA Class 2
·Clinical Chemistry
COALESCENT SURGICAL U-CLIP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ABRAMS MULTIDENSITY POLYURETHAN FOAM WOUND DRESSING SYSTEM
FDA Adverse Event
Other
·DR LEN'S MEDICAL PRODUCTS·Product code FRO·October 11, 2005
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 3, 2013
RENEGADE HI-FLO MICROCATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code KRA·March 30, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·August 25, 2014
Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, 5.5mm Part Number: 72202902
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·April 29, 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
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