14 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VENA CAVA FILTER
FDA 510(k)
FDA Class 2
·Cardiovascular
Map-iT
FDA UDI
ACCESS POINT TECHNOLOGIES, INC.·00818083011482·Fixed, 4 electrode, HIS, 5mm electrode spacing
ERA ANGLE 3.25MM IMP MICRO HEAD 10X4MM, Ti
FDA UDI
STERNGOLD DENTAL LLC·00841549108013·Designed for both transitional and long-term de...
Elite®Opti-MIM® Bondable Buccal Tubes
FDA UDI
Ortho Organizers, Inc.·00190707070328·.022 U6L STD OPTI-MIM -14T DB
SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 DIAMETER, 145CM LENGTH, SUPPORT) SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 D
FDA 510(k)
FDA Class 2
·Cardiovascular
PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Toxicology
STEM: AMISTEM C CEMENTED STD STEM SIZE 4
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·March 24, 2021
DOUBLE MOBILITY LINER
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·March 12, 2025
CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL 48
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·July 7, 2020
BARD-PARKER
FDA Adverse Event
Injury
·ASPEN SURGICAL PRODUCTS, INC.·Product code GES·June 19, 2014
PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·November 17, 2010
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·January 3, 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
The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Inc.·April 10, 2019