18 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MEMOMETAL MEMORY STAPLES
FDA 510(k)
FDA Class 2
·Orthopedic
Reuter Venturi™
FDA UDI
MEDTRONIC XOMED, INC.·00681490032773·VENT TUBE 1070031 5PK VENTURI BOBB 1.27
Reuter Venturi™
FDA UDI
MEDTRONIC XOMED, INC.·00763000039776·VENT TUBE 1070031 5PK VENTURI BOBB 1.27
Vari-Simplex - Archwire
FDA UDI
ORMCO CORPORATION·00889989026504·ARCH ALEXANDER SZ 2 LWR 16 RD PK 10
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108690491·Titanium Anatomic Angulated Abutment Internal H...
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108696639·Twist Drill Ø3.8mm, Long
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290114690171·Open Tray Impression Coping Screw SP, Short
SETROX S 45
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO.·Product code DTB·February 26, 2007
AQUANET, MODEL EC 2000
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
VERCISE CARTESIA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·March 27, 2020
Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital processing of medical image data sets and treatment plans in radiation oncology.
FDA Enforcement
Class II
·Ongoing·PTW-FREIBURG·February 28, 2024
OFFSET CUP REAMER HANDLE
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·March 6, 2018
CONTOUR USB
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·April 22, 2013
INFUSOR SV 2, 12 PACK
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·April 26, 2011
ANALYTICAL P MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·July 3, 2008
Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital processing of medical image data sets and treatment plans in radiation oncology.
FDA Recall
Open, Classified
·PTW-FREIBURG Lorracher Str. 7 Freiburg Im Breisgau Germany·Product code IYE·February 8, 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