9 results
·
20ms
·
Sources: EU EUDAMED, US FDA
TROJAN NATURALAMB NATURAL MEMBRANE CONDOM W/SPERM.
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Synergy
FDA UDI
Rmo, Inc.·00885797486707·SYN ROTH .018 HK345 GIN 5-5 20 BKTS
Zavation IBF System
FDA 510(k)
FDA Class 2
·Orthopedic
HASS ZIRTOOTH MODEL ZORTOOTH H. ZIRTOOTH T. ZIRTOOTHC, ZIRTOOTH P
FDA 510(k)
FDA Class 2
·Dental
GIA 100-4.8 SINGLE USE RELOADABLE
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY USSC·Product code GDW·June 25, 2014
PINNACLE PELVIC FLOOR REPAIR KITS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·November 18, 2010
CARTO¿ XP SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL)·Product code DQK·January 8, 2013
DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 13, 2025
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