14 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SURGICAL DRAPE KIT - D.I.R.R.A. SRL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Arthrex®
FDA UDI
ARTHREX, INC.·00888867522404·Cannulated Canc Screw,36mm Thd,7.0x80mm
AOS CANNULATED CANCELLOUS SCREW, 36mm THREAD 7.0mm x 80mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665010022·
TRIALTIS
FDA UDI
Medos International Sàrl·10705034597027·TRIALTIS Spine System Polyaxial Sacral Alar Ili...
SPINE SYSTEM EVOLUTION
FDA 510(k)
FDA Class 2
·Orthopedic
BRIDGE SE SELF-EXPANDING STENT DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
REMSTAR AUTO M SERIES
FDA Adverse Event
Injury
·RESPIRONICS, INC.·Product code BZD·April 14, 2024
GOOD SAM CINCINNATI OH 1
FDA Adverse Event
Malfunction
·SORIN GROUP USA, INC.·Product code DWE·December 11, 2008
COMP RVRS 25MM BSPLT HA+ADPTR
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·October 7, 2019
DEPUY ASR XL FEM IMP SIZE 49
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·April 8, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 23, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·August 27, 2014
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