18 results
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29ms
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Sources: EU EUDAMED, US FDA
MAY ILLUMINATED/INFUSION PIC
FDA 510(k)
FDA Class 1
·Ophthalmic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257010075·M.3 SOFT OA BRACE, VARUS, RIGHT, XS
Mini-Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78014111·Mini Sprint Bracket McLaugh/Benn/Trev. .022" ma...
Mini-Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78014111001·Mini Sprint Bracket McLaugh/Benn/Trev. .022" ma...
Mini-Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78014110101·Mini Sprint Bracket McLaugh/Benn/Trev. .022" ma...
Mini-Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78014110051·Mini Sprint Bracket McLaugh/Benn/Trev. .022" ma...
VITROS CHEMISTRY PRODUCT NA+ SLIDES; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2
FDA 510(k)
FDA Class 2
·Clinical Chemistry
WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC IRMA DIAGNOSTIC ASSAY KIT, MODEL 3KG056
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PORTEX BIVONA TTS TRACHEOSTOMY TUBE
FDA Adverse Event
Injury
·SMITHS MEDICAL ASD; INC.·Product code JOH·February 5, 2020
PORTEX BIVONA TTS TRACHEOSTOMY TUBE
FDA Adverse Event
Injury
·SMITHS MEDICAL ASD; INC.·Product code JOH·February 5, 2020
PORTEX BIVONA TTS TRACHEOSTOMY TUBE
FDA Adverse Event
Injury
·SMITHS MEDICAL ASD; INC.·Product code JOH·February 5, 2020
PORTEX BIVONA TTS TRACHEOSTOMY TUBE
FDA Adverse Event
Injury
·SMITHS MEDICAL ASD; INC.·Product code JOH·February 5, 2020
Dr. Landi EVLT Pack, part number AMS1483(E Dr. Landi EVLT Pack, part number AMS1483(E
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 8, 2014
CONSTELLATION VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·October 18, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 25, 2007
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180
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