25 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NON REINFORCED SURGICAL GOWNS, FILM REINFORCED SURGICAL GOWNS, FABRIC REINFORCED SURGICAL GOWNS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Shannon Recta Round Shank
FDA UDI
Gebr. Brasseler GmbH & Co. KG·14053613289587·
neria™soft tubing
FDA UDI
Unomedical A/S·05705244001671·Single use infusion tubing for subcutaneous inf...
Custom Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964108976·Endo Carry-On Procedure Kit
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00811801036118·2x12mm Up-angled Caspar Rongeur – 6” long
Endo Carry-On Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964104749·Endo Carry-On Procedure Kit
remanium®
FDA UDI
DENTAURUM GmbH & Co.KG·J011102652000·remanium® star MD I milling blank, 10 mm border...
REPROCESSED DYONICS ARTHROSCOPIC BURS
FDA 510(k)
FDA Class 2
·Orthopedic
SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT AND ACM AND MIXEVACII
FDA 510(k)
FDA Class 2
·Orthopedic
RETROFLEX DILATOR KIT
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DRE·May 9, 2013
PLUM A+ DRIVER ED 2
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·August 28, 2014
TERUMO PERFUSION SYSTEM 8000
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEM CORP·Product code JOR·May 23, 2011
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·April 14, 2015
Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
FDA Enforcement
Class I
·Terminated·Animas Corporation·April 10, 2013
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
EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021
Model Number L101, ESSENTIO DR SL Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·July 14, 2021
VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021