14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HEALOS II BONE GRAFT SUBSTITUTE
FDA 510(k)
FDA Class 2
·Dental
Deploy™ Expandable Interbody System
FDA UDI
Southern Spine LLC·00815351022546·Lumbar Expandable Cage, 8 Degree, 32mm Length, ...
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810057371981·Minor Procedure Table Deluxe Pad
KLEIN SURGICAL INFILTRATION PUMP, MODEL KIP-II
FDA 510(k)
FDA Class 2
·General Hospital
DISPOSABLE PVC SYNTHETIC EXAM GLOVES, POWDER FREE
FDA 510(k)
FDA Class 1
·General Hospital
NDEHP PRIMARY PLUM PREPIERCED Y
FDA Adverse Event
Malfunction
·HOSPIRA HOLDINGS DE COSTA RICA LTD.·Product code FRN·April 25, 2013
WAVEWRITER ALPHA?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·April 13, 2026
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·September 11, 2014
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code NIQ·July 25, 2008
DEXTRUS 4136
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVZ·April 29, 2011
BD SAF-T-INTIMA W/Y ADAPTER YEL 24GA X .75I
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·April 23, 2025
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
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
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015