27 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES
FDA 510(k)
FDA Class 2
·Orthopedic
2.4MM VA LOCKING SCREW STARDRIVE 22MM
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·June 25, 2013
VA LOCKSCR Ø2.4 SELF-TAP L18 TAN
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HRS·July 15, 2013
2.4MM TI LOCKING SCR SLF-TPN WITH STARDRIVE RECESS 18MM
FDA Adverse Event
Malfunction
·SYNTHES BETTLACH·Product code HWC·June 21, 2017
SCREW, FIXATION, BONE
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HWC·December 24, 2015
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·July 30, 2015
2.4MM TI LOCKING SCR SLF-TPN WITH STARDRIVE RECESS 18MM
FDA Adverse Event
Malfunction
·SYNTHES BETTLACH·Product code HWC·June 21, 2017
PLATE, FIXATION, BONE
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HRS·October 24, 2015
REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
PLUM A+ DRIVER NEW
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·May 2, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·September 19, 2014
DEEP BRAIN STIMULATION LEAD
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code MHY·May 19, 2011
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
Item # 4042-CPR Rescue Kit, containing CPR shield with one way valve & barrier filter. brand Lifeline, UPC 845174004429 each; UPC 845174004436 master case of 6. Item #4043-CPR Rescue Kit, containing CPR shield with one way valve & barrier filter. brand Lifeline. UPC Red color kit: 845174005464; UPC Lime color kit: 845174005594; UPC Purple color: 845174005600; UPC of master case of 6 845174005471 (2 each color) Item # 4037, Outfitter First Aid Kit, CPR shield with one way valve & barrier filter, brand Lifeline, UPC 845174003453
FDA Enforcement
Class II
·Terminated·Lifeline First Aid LLC·July 13, 2016
Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SEP). Model Number: WA91327U. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·August 27, 2025
Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·November 6, 2024
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Enforcement
Class I
·Ongoing·Covidien·November 8, 2023
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