14 results
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20ms
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Sources: EU EUDAMED, US FDA
WHEELCHAIR MODEL STS
FDA 510(k)
FDA Class 2
·Physical Medicine
NOBELACTIVE INTERNAL NP 3.5X11.5MM
FDA Adverse Event
Injury
·NOBEL BIOCARE AB·Product code DZE·August 13, 2020
NOBELACTIVE INTERNAL RP 4.3X10MM
FDA Adverse Event
Injury
·NOBEL BIOCARE USA INC·Product code DZE·September 8, 2020
NOBELACTIVE INTERNAL NP 3.5X11.5MM
FDA Adverse Event
Injury
·NOBEL BIOCARE AB·Product code DZE·August 13, 2020
BIOSENSE WEBSTER PATIENT CABLE AND LEADWIRES
FDA 510(k)
FDA Class 2
·Cardiovascular
BONUS-ORTHOPEDIC BONE SCREW FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PRECISION MONTAGE MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 7, 2024
ASR ACETABULAR IMPLANT 56
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·April 22, 2013
CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code LWR·July 3, 2008
ASR UNI FEMORAL IMPL SIZE 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·April 13, 2011
Aquarius LPH 511-A CRLF2 Distal Probe Green, model no. LPH 511-A The CRLF2 Distal probe, labelled in green, consists of two probes (71kb and 131kb) that are situated distal (telomeric) to the CRLF2 gene
FDA Enforcement
Class II
·Terminated·Cytocell Ltd.·February 17, 2021
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
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
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018