11 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MEDRAD CONTINUUM MR INFUSION SYSTEM WITH WIRELESS REMOTE ACCESSORY
FDA 510(k)
FDA Class 2
·General Hospital
Vented Vial Adapter Transfer Device
FDA UDI
WEST PHARMA. SERVICES IL, . LTD·07290108241334·Vented Vial Adapter 20mm FLL- VF
INTRAUTERINE DELIVERY SYSTEM - INJECTOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
NANMA ADJUSTABLE CONSTRICTION RING
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 28, 2024
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FPA·April 23, 2013
ENDOPATH** XCEL* TROCAR
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·April 29, 2011
ISOFLEX S
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·July 11, 2008
Product is a lithium ion battery charger sold as both a stand-alone accessory, and as part of endoscopy system sets. --- Stand alone labeling: Vision Sciences Battery Charger, Lithium Ion [REF] 07-3051; [MFG Symbol] Vision-Sciences, Inc., 40 Ramland Road South, Orangeburg, NY 10962 USA. Accessory to endoscopy kits used to charge/recharge lithium ion batteries.
FDA Recall
Terminated
·Vision-Sciences, Inc.·Product code EOB·December 27, 2011
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
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024