21 results
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37ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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3I PATIENT-SPECIFIC DENTAL ABUTMENT AND OVERDENTURE BAR
FDA 510(k)
FDA Class 2
·Dental
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032263·Baltic Denture System BDLoad ↓ Sw6 PLSEum6DFs B...
THE QUALITY ASSURANCE SERVICE CORP.
FDA registration
THE QUALITY ASSURANCE SERVICE CORP.·1 product·🇺🇸 United States
MARQUETTE EAGLE MONITOR MODEL 4000, MODEL N3024
FDA 510(k)
FDA Class 2
·Cardiovascular
BRANAN MEDICAL CORPORARTION MONITECT THC DRUG SCREEN TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
XORAN
FDA Adverse Event
Malfunction
·XORAN TECHNOLOGIES, INC.·Product code JAK·May 9, 2011
SCP PANEL CENTRIFUGE JMS
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DWA·November 5, 2013
SCP PANEL CENTRIFUGE JMS
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DWA·March 14, 2014
SCP CONTROL PANEL
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTQ·January 5, 2012
CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DWA·January 19, 2018
CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND GMBH·Product code DWA·January 5, 2022
STOCKERT JMS CENTRIFUGAL PUMP SYSTEM
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTQ·January 5, 2012
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 29, 2013
PROPHY-JET POWDER
FDA Adverse Event
Injury
·DENTSPLY PROFESSIONAL·Product code KOJ·March 23, 2011
ASCENSIA CONTOUR
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·April 18, 2008
STOCKERT CENTRIFUGAL PUMP (SCP) SYSTEM
FDA Adverse Event
Injury
·SORIN GROUP DEUTSCHLAND·Product code DWA·May 7, 2010
EVOLUT FX PLUS VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·April 14, 2025
FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below descriptions and corresponding article numbers. 1. FLS - Foot Locking Plates System, Cancellous Stabilization Screw; Article Numbers: 37303-10, 37303-12, 37303-14, 37303-16, 37303-18, 37303-20, 37303-22, 37303-24, 37303-26, 37303-28, 37303-30. 2. FLS - Foot Locking Plates System, Cortical Screw; Article Numbers: 32271-10, 32271-12, 32271-14, 32271-16, 32271-18, 32271-20, 32271-22, 32271-24, 32271-26, 32271-28, 32271-32, 32271-34. 3. FLS - Foot Locking Plates System, Cortical Stabilization Screw; Article Numbers: 37304-10, 37304-12, 37304-14, 37304-16, 37304-18, 37304-20, 37304-22, 37304-24. 4. FLS - Foot Locking Plates System, FLS Plate, Curved; Article Numbers: 21413-6. 5. FLS - Foot Locking Plates System, FLS Plate, H-Shape; Article Numbers: 21431-ME. 6. FLS - Foot Locking Plates System, FLS Plate, L-Shape; Article Numbers: 21482, 21483. 7. FLS - Foot Locking Plates System, FLS Plate, Straight; Article Numbers: 21421-5. 8. FLS - Foot Locking Plates System, Stabilization Screw; Article Numbers: 37241-10, 37241-12, 37241-14, 37241-16, 37241-18, 37241-20, 37241-22, 37241-24, 37241-26, 37241-28, 37241-30. 9. HOL - Hallux Osteotomy Locking Plate, Hallux Osteotomy Plate; Article Numbers: 21015-08, 21015-09.
FDA Enforcement
Class II
·Ongoing·I.T.S. GmbH·April 1, 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
The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·March 23, 2016