13 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DA VINCI SONICPRO CLEANING SYSTEM, MODEL 400253
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NOBELREPLACE CC PMC RP 4.3X10MM
FDA Adverse Event
Injury
·NOBEL BIOCARE USA INC·Product code DZE·June 15, 2021
NOBELPARALLEL CC NP 3.75X13MM
FDA Adverse Event
Injury
·NOBEL BIOCARE AB·Product code DZE·March 8, 2021
NOBELPARALLEL CC NP 3.75X13MM
FDA Adverse Event
Injury
·NOBEL BIOCARE AB·Product code DZE·March 8, 2021
FOCAL SIM
FDA 510(k)
FDA Class 2
·Radiology
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
2520274-2013-02089
FDA Adverse Event
Injury
·SYNTHES USA·Product code HSB·April 23, 2013
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·April 29, 2011
RIATA ACTIVE FIXATION LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000594;
FDA Enforcement
Class II
·Ongoing·Beaver Visitec International, Inc.·September 4, 2024
CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 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
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024