17 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SAPHYRE BIPOLAR ABLATION PROBES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CARDEON ASCENDING BALLOON CANNULA (ABC)
FDA 510(k)
FDA Class 2
·Cardiovascular
NON-STERILE POWDER FREE PINK LATEX EXAMINATION GLOVE AND NON-STERILE POWDER FREE PINK LATEX EXAMINATION GLOVE WITH STRAW
FDA 510(k)
FDA Class 1
·General Hospital
INFINION CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 4, 2021
S3 EX - 3005
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·April 2, 2013
MESHGRAFT II DERMATOME WITH RATCHET
FDA Adverse Event
Injury
·ZIMMER SURGICAL·Product code FZW·March 23, 2011
NELLCOR N-550 PULSE OXIMETER
FDA Adverse Event
Malfunction
·NELLCOR PURITAN BENNETT·Product code DQA·April 18, 2008
BD SYRINGE LUER-LOK TIP
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·June 3, 2020
CONTINUUM ACETABULAR SHELL WITH CLUSTER HOLES
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·June 7, 2018
KINECTIVE TECHNOLOGY MODULAR NECK
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·June 7, 2018
NEUTRAL LINER
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·June 7, 2018
ZIMMER M/L TAPER MODULAR FEMORAL STEM WITH KINECTIV TECHNOLOGY PRESS-FIT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code LPH·June 15, 2016
Brand Name: Canturio¿ Smart Extension Product Name: CSE Implant Model/Catalog Number: 43-5570-030-14 Product Description: Tibial stem extension for use with Zimmer Persona¿ Personalized Knee System; 14mm diameter x 30mm height. Implantable device with integrated electronics for passive kinematic data collection. Single-use, sterile. Packaged in a sterile blister and outer shelf pack. Sold individually. Component: Yes. The Canturio¿ Smart Extension (CSE) is a tibial implant component intended for use with the Zimmer Persona¿ Personalized Knee System.
FDA Enforcement
Class II
·Ongoing·Canary Medical, Inc.·July 16, 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
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018