13 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PORT ACCESS SYSTEMS ENDODIRECT ARTERIAL CANNULA MODEL ED24 (OLD CODE WAS-DFK24)
FDA 510(k)
FDA Class 2
·Cardiovascular
infinity OCTAGON TL WP Cover screw GH 0.0 mm
FDA UDI
Hager & Meisinger Gesellschaft mit beschränkter Haftung·E0HM50937301·Cover screw GH 0.0 mm for infinity OCTAGON Dent...
CHEMO-AIDE DISPENSING PIN
FDA 510(k)
FDA Class 2
·General Hospital
ARIEL RADIO FREQUENCY (RF) ELECTROSURGICAL CONTROL MODULE AND ACCESSORIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OPTIBOND XTR
FDA Adverse Event
Injury
·KERR CORPORATION·Product code KLE·August 8, 2014
LINEAR? ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 12, 2026
THORACENTESIS SET
FDA Adverse Event
Injury
·ARROW INTERNATIONAL INC.·Product code JOL·May 1, 2013
MONOCRYL PLUS SUTURE
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code GAM·September 16, 2014
FOUNDATION KNEE
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code JWH·April 21, 2011
MDLR CNLTD TRIDRV DRVR
FDA Adverse Event
Malfunction
·EXACTECH, INC.·Product code LXH·August 29, 2023
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP40; b) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP45; c) PAED. TRACHEOSTOMY TUBE 5.0MM FLEXTEND PLUS , Product Code/List Number/Item Code 60PFP50; d) PAED. TRACHEOSTOMY TUBE 5.5MM FLEXTEND PLUS , Product Code/List Number/Item Code 60PFP55
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024
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