18 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ATTAIN HYBRID GUIDE WIRES, MODEL GWR419378, GWR419388, GWR419478, GWR419488
FDA 510(k)
FDA Class 2
·Cardiovascular
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA UDI
FX SOLUTIONS·03701037312544·32/10 HUMELOCK REVERSED BROACH
Audit MicroControls Control FD Urine Chemistry
FDA UDI
AALTO SCIENTIFIC·B085K0662100·
C-Taper Head
FDA UDI
Howmedica Osteonics Corp.·07613327016314·Low Friction Ion Treatment
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0132100·Trial, TLIF, 27L OB CRV 7Deg, 10mm
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA UDI
FX SOLUTIONS·03701037317617·32/10 HUMELOCK REVERSED BROACH WITH RADIUS
OMNIFIT SER. II INSERT-10 DEG.
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LPH·October 2, 2013
TRUWAVE
FDA 510(k)
FDA Class 2
·Neurology
SEEDLINKS, MODELS 70301, 70302, 70303
FDA 510(k)
FDA Class 2
·Radiology
BD ULTRA FINE PEN NEEDLES
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·October 11, 2021
TRIDENT ALL POLY CUP-CROSSFIRE
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code JDI·August 17, 2011
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 15, 2024
AC POWER MODULE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·February 27, 2013
PCA PLS II
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·March 22, 2011
ANGIOGUARD RX
FDA Adverse Event
Injury
·CORDIS CORPORATION·Product code NTE·June 17, 2008
OMNIFIT SER. II INSERT 20 DEG.
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LPH·October 25, 2013
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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015