13 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
PINPOINTE FOOTLASER MODEL 6W, 30W, 100W
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Infinity Internal Hex System
FDA UDI
ACE SURGICAL SUPPLY CO., INC.·00614950008056·UCLA Ø3.5mm 4.5MM WIDE NON HEX FOR INFINITY INT...
TRI-CAM Dental Implant System
FDA UDI
ACE SURGICAL SUPPLY CO., INC.·00614950007998·UCLA Ø3.5mm 4.5MM WIDE NONHEX W/SCREW FOR INFIN...
MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAN·April 8, 2020
NUGARD POWDERFREE, BLUE POLYMER COATED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE
FDA 510(k)
FDA Class 1
·General Hospital
SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221
FDA 510(k)
FDA Class 2
·Hematology
LINER AND SHELL WITH PLASTIC BARRIER 48 MM I.D. 60 MM O.D.
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·May 3, 2023
EDWARDS ESHEATH INTRODUCER SET
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·December 6, 2021
EDWARDS TF SHEATH UNKNOWN
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·October 30, 2021
POLY C-OMCP-VISUB (H3000)
FDA Adverse Event
Death
·PHILPS HEALTHCARE·Product code IZL·May 11, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 6, 2013
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 16, 2014
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