11 results
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28ms
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Sources: EU EUDAMED, US FDA
PROLACTIN (LACTOGEN) TEST SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Map-iT
FDA UDI
ACCESS POINT TECHNOLOGIES, INC.·00818087020251·Steerable Duo-Decapolar Catheter, Multi-Purpose...
URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GE LIGHTSPEED ACT FP16
FDA 510(k)
FDA Class 2
·Radiology
MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S -4
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·September 12, 2022
ACCURUS 800CS
FDA Adverse Event
Malfunction
·ALCON-IRVINE TECH CTR·Product code HQC·May 7, 2014
ENDO GIA II 45-3.5 DLU
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY USSC·Product code GDW·January 2, 2013
INTEGRATED APD SET W/CASSETTE3-PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 17, 2010
CUP: MPACT ACETABULAR SHELL Ø52 TWO-HOLES
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·April 10, 2024
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