10 results
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18ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MEDISIZE GOLD
FDA 510(k)
FDA Class 2
·Anesthesiology
SURGICAL SYSTEM WITH CRYOGUIDE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CENTERPULSE, SPINE-TECH DIVISION CEMENT RESTRICTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
REMSTAR PRO C-FLEX+
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·November 18, 2025
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·April 2, 2013
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·May 27, 2008
CONTAK RENEWAL
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 13, 2011
CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
Cocoon Convective Warming System, Product Code: CWS4000 (110V).
FDA Enforcement
Class II
·Terminated·Care Essentials Pty., Ltd.·February 12, 2020
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