16 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DENTORIUM CONVERTIBLE ACRYLIC
FDA 510(k)
FDA Class 2
·Dental
INTER FIX™ RP Threaded Fusion Device
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00673978957449·18X20 INTERFIXRP FUSION DEVICE
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040012444·Zirlux 16+ B2 95X22
neoWave LS
FDA UDI
XENIX MEDICAL LLC·00818345023871·BAYONETTED STRAIGHT RING CURETTE
Battalion
FDA UDI
ALPHATEC SPINE, INC.·00840967186771·Battalion, LLIF Trial, 10°, 18 mm Wide, 20 mm X...
Vasomedical-Biox™ ARCS S/W & Dongle, Comb (3 CH ECG & ABP), USB
FDA UDI
VASOMEDICAL, INC.·00817980020238·ARCS Analysis & Reporting S/W & Dongle, Comb (3...
TITAMAX SMART IMPLANT (4.1) 4.0X13
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·May 11, 2018
GLUCOPRO INFUSION SET, MODEL GPISXXXXXXXX SERIES
FDA 510(k)
FDA Class 2
·General Hospital
DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 19, 2013
UNK
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code JDI·February 24, 2011
SOLUSET VENTED 100 X 60
FDA Adverse Event
Malfunction
·HOSPIRA DE COSTA RICA LTD.·Product code FPA·March 11, 2008
CANNULA & CATHETER
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code DWF·April 22, 2025
MUSTANG?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·September 2, 2025
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
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025