14 results · 20ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

REPLACE ONE PIECE IMPLANT, HA, REPLACE ONE PIECE IMPLANT, TIUNITE

FDA 510(k)
FDA Class 2 ·Dental

Bionet

FDA UDI
SUNTECH MEDICAL, INC.·10840935108986·

ZYGOMATIC IMPLANT

FDA Adverse Event
Injury ·NORIS MEDICAL LTD·Product code DZE·April 15, 2025

ZYGOMATIC IMPLANT

FDA Adverse Event
Injury ·NORIS MEDICAL LTD·Product code DZE·July 21, 2024

ZYGOMATIC IMPLANT

FDA Adverse Event
Injury ·NORIS MEDICAL LTD·Product code DZE·April 15, 2025

INTUITIVE SURGICAL STERO VIEW ENDOSCOPIC SYSTEM

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

INDIGO LASEROPTIC TREATMENT SYSTEM

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

TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·March 27, 2013

SECURE II MED/SURG BED

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FNL·February 14, 2011

COLLEAGUE VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 4, 2008

BIPAP AUTO

FDA Adverse Event
Injury ·RESPIRONICS INC.·Product code BZD·October 21, 2010

MONOFOCAL IOL

FDA Adverse Event
Injury ·AMO PUERTO RICO MFG. INC.·Product code HQL·March 14, 2024

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

The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018