11 results · 21ms · Sources: EU EUDAMED, US FDA

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MOBIS SPINAL IMPLANT

FDA 510(k)
FDA Class 2 ·Orthopedic

ADVANCE®

FDA UDI
Microport Orthopedics Inc.·M684K00610821·

STACKHOUSE SMOKE EVACUATOR, MODELS ST-3000, ST 3100

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

TPO IGG ANTIBODY EIA TEST

FDA 510(k)
FDA Class 2 ·Immunology

INCLUSIVE TAPERED IMPLANT 4.7 MMD X 11.5 MML X 4.5 MMP

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·May 2, 2024

NA

FDA UDI
Zimmer, Inc.·00889024186330·

TRILOGY 100

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code CBK·April 9, 2013

INRATIO2

FDA Adverse Event
Other ·ALERE SAN DIEGO, INC.·Product code GJS·April 8, 2011

LIFEVEST WCD 3000 SYSTEM

FDA Adverse Event
Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·June 13, 2008

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

CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015