20 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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REPROCESSED ELECTROSURGICAL ELECTRODE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Surestream
FDA UDI
ORIDION MEDICAL 1987 LTD.·10884521552197·SURELINE O2 ADULT
BENCO
FDA UDI
BENCO DENTAL SUPPLY CO.·00366975018526·Amalgam Carrier Double Ended Stainless Steel Re...
IRONMAN
FDA UDI
FGX INTERNATIONAL INC.·00193033435717·
IRONMAN
FDA UDI
FGX INTERNATIONAL INC.·00193033435670·
PERSONAL OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00027995680017·
IRONMAN
FDA UDI
FGX INTERNATIONAL INC.·00193033435694·
PERSONAL OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00884409072833·
PERSONAL OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00884409073557·
IRONMAN
FDA UDI
FGX INTERNATIONAL INC.·00193033435687·
IRONMAN
FDA UDI
FGX INTERNATIONAL INC.·00193033435663·
IRONMAN
FDA UDI
FGX INTERNATIONAL INC.·00193033435700·
RX HERCULINK PLUS BILIARY STENT SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
COMPOSIX E/X MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INTERSTIM
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code EZW·March 20, 2013
ASR ACETABULAR CUPS 50
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 24, 2011
HEARTMATE XVE LVAS
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·March 12, 2008
BARD EP XT Steerable, Product Number 200794; 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
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