11 results · 35ms · Sources: EU EUDAMED, US FDA

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CG-7000DX-BT ECG RECORDER/TRANSMITTER

FDA 510(k)
FDA Class 2 ·Cardiovascular

PerforMax

FDA UDI
Respironics, Inc.·00606959011892·Performax Mask with Entrainment Elbow, Leak 2, ...

Ophthalmic Forceps

FDA UDI
KATENA PRODUCTS, INC.·00841668106372·HELVESTON FIXATION FORCEPS WITH LOCK

ACUMATCH GXL 15DEG LINER 36MM SZ J

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JDI·April 19, 2024

CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1

FDA 510(k)
FDA Class 1 ·Ophthalmic

REPROCESSED GUIDEWIRES

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

GORE EXCLUDER AAA ENDOPROSTHESIS

FDA Adverse Event
Injury ·W. L. GORE & ASSOCIATES·Product code MIH·January 11, 2013

FLEXTEND

FDA Adverse Event
Malfunction ·CPI - DEL CARIBE·Product code NVN·April 11, 2013

DEPUY 1 GENTAMICIN CEMENT 40G

FDA Adverse Event
Injury ·DEPUY CMW·Product code MBB·April 11, 2011

AUTOCAT2 WAVE

FDA Adverse Event
Malfunction ·ARROW INTERNATIONAL INC·Product code DSP·May 22, 2008

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