13 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNERMED CHLORIDE REAGENT KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
RIWO-ART
FDA UDI
Richard Wolf GmbH·04055207044698·TROCAR TIP DULL SZ 3.5MM WL 169MM distal tip r...
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113783·AIR INJECT CANNULA 25GA
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515228306·Drum Elevator, 2mm wide tip, 5 1/2"
3.8mm CS Facet Compression Device
FDA UDI
INTERVENTIONAL SPINE, INC·81195401029448·3.8mm x 20-25mm
Synapse 3D, Synapse 3D Base Tools v6.1
FDA 510(k)
FDA Class 2
·Radiology
PRESSON ELECTRODE
FDA 510(k)
FDA Class 2
·Neurology
ESPRIT VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC.·Product code CBK·June 30, 2014
UNKNOWN DEPUY ASR HIP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWY·November 17, 2010
VERSACARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·November 30, 2012
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
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023