11 results
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19ms
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Sources: EU EUDAMED, US FDA
ZYMALAR IMPLANT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113226·VITRECTOMY KNIFE 20GA (BX/5)
3M™ Victory Series™
FDA UDI
3M UNITEK CORPORATION·00652221111999·3M™ Victory Series™ First Molar Bands, 902-284,...
VENTURE IDD OXYGEN CONSERVING DEVICE IDD 20EX AND 50EX
FDA 510(k)
FDA Class 2
·Anesthesiology
LIPISYSTEMS AQUAVAGE, MODELS AV2000 AND AV1200
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CUP: MPACT ACETABULAR SHELL 50 NO-HOLE
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·June 4, 2021
ENDO GIA ROTICULATOR 45-2.5 SULU
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL·Product code GDW·June 25, 2014
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
MEDEL S.P.A.·Product code BTI·January 8, 2013
ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code KNT·November 18, 2010
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
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