10 results · 36ms · Sources: EU EUDAMED, US FDA

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LIGHT AGE Q-CLEAR LASER, MODEL 701-1101

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Baltic Denture System BDLoad

FDA UDI
Merz Dental GmbH·D7091033259·Baltic Denture System BDLoad BDLoad ↓ Mm7 PLSEu...

PORTABLE NON-CONTACT TONOMETER, MODEL PT100

FDA 510(k)
FDA Class 2 ·Ophthalmic

ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 34470,34475,34479

FDA 510(k)
FDA Class 2 ·Microbiology

PROXIMATE** LINEAR CUTTER RELOAD - STANDARD

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·April 3, 2013

LIGAMAX-5MM

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·March 30, 2011

PROFEMUR(R) XM STEM

FDA Adverse Event
Death ·MICROPORT ORTHOPEDICS INC.·Product code KWA·August 25, 2014

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

Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·October 13, 2021