15 results
·
21ms
·
Sources: EU EUDAMED, US FDA
EQ-PRC LC WARFARIN GENOTYPING KIT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Thermaloy
FDA UDI
Rmo, Inc.·00885797017383·THERMALOY(R) PREFORMED NATURAL ARCH MX .019 X .025
SECURCUT ASPIRATION BIOPSY NEEDLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GLITTER EYES (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
FDA 510(k)
FDA Class 2
·Ophthalmic
BD¿ PRN ADAPTER
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·March 8, 2023
BD¿ PRN ADAPTER
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FPA·January 6, 2023
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·April 23, 2013
FLEXIVA (TM) HIGH POWER SINGLE-USE LASER FIBER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code GEX·April 29, 2011
RIATA ST ACTIVE FIXATION LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008
LEGION PS OXIN FEM SZ5 LT
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·February 5, 2018
GII OVAL RESURFACING PAT 32MM
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·December 18, 2015
NAIL, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code JDS·July 25, 2016
NAIL, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code JDS·July 25, 2016
Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 2016
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