26 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IBED WIRELESS WITH IBED AWARENESS
FDA 510(k)
FDA Class 2
·General Hospital
Neodent
FDA UDI
JJGC Indústria e Comércio de Materiais Dentários S/A.·07899878047063·NGS REGULAR TAPERED DRILL
RingLoc® Hip System
FDA UDI
Biomet Orthopedics, LLC·00880304185708·
MEDIUM 199, CATALOG NO. 210-3536
FDA 510(k)
FDA Class 1
·Hematology
Cortium Universal OCT Spinal Fixation System
FDA UDI
Ulrich Medical Usa, Inc.·00814386026468·Screw, Ø 3.5mm, length 36mm, high angulation
HARDYDISK NAFCILLIN, 1 MCG
FDA 510(k)
FDA Class 2
·Microbiology
EMTRAC; DELPHIN; SEMTRAC 2000 SET
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MOTO PARTIAL KNEE TIBIAL INSERT FIX S4 RM - 8MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code HSX·January 25, 2022
Gibralt
FDA UDI
Choice Spine, LP·10885862303059·
Gibralt®
FDA UDI
INNO Holdings, Inc.·M711050021035360·POSTERIOR CERVICAL, ROD, STRAIGHT, CoCr, 3.5 X ...
MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S3 RM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code HSX·May 8, 2023
CAIMAN DISP.INSTR.NON ARTICUL.D:5/360MM
FDA Adverse Event
Malfunction
·AESCULAP, INC.·Product code GEI·March 4, 2015
M2A-T UNIV 2-HOLE SHL
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·August 21, 2017
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·May 9, 2013
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDI·September 19, 2014
ATLANTIS SR PRO CORONARY IMAGING CATHETER, MODEL 38942
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - FREMONT·Product code DQO·May 26, 2011
M2A HI CARBON TAPER LINER
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·August 7, 2017
M2A HI CARBON MODULAR HEAD
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·August 7, 2017
The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Numbers: a) 955626 b) 955558 c) 955701 PrisMax V2 Preventive Maintenance Kit, Product Code SC616 ARPS PUMP, Product Code SC6035 ARPS Pump Assembly, Product Code SC6053
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corporation·March 10, 2021
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