15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFACE, MODEL CB4014
FDA 510(k)
FDA Class 2
·Cardiovascular
Key Surgical K-Wires and Steinmann Pins
FDA UDI
KEY SURGICAL, INC.·00849771012887·K-Wires, Single diamond, round end, .062-inch (...
NA
FDA UDI
KEY SURGICAL, INC.·10849771049507·K-Wires, Single diamond, round end, .062-inch (...
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704293203·
ConMed Linvatec
FDA UDI
Provision·B504OM50712530·
Sklar®
FDA UDI
SKLAR CORPORATION·10649111096686·F.O. WISC AMER STYLE SIZE 2
HALL®
FDA UDI
Conmed Corporation·20845854045999·OSCILLATOR BLADE, COATED, 25 X 90 X 1.27 MM
SURGITRON IEC II
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FLAVORED MALE LATEX CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 26, 2025
IN TOUCH ZU
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·April 22, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 27, 2011
S-ROM M HEAD 36MM +6
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD·Product code JDI·July 7, 2008
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
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018