11 results · 28ms · Sources: EU EUDAMED, US FDA

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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