10 results · 21ms · 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.

da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)

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

Syntec Osteo-plate and screw Fixation

FDA UDI
SYNTEC SCIENTIFIC CORPORATION·04712782853960·Cortex Screw Self-Tappingφ2.7 x L34mm

NA

FDA UDI
Synthes GmbH·10886982144836·2.7MM CORTEX SCREW SELF-TAPPING 34MM

LEONE SPA

FDA UDI
LEONE SPA·08033707061137·BRACKETS 22 PREM

SRS VAGINAL EMG/STIMULATION PERINEOMETER SENSOR SRS ANAL EMG/STIMULATION PERINEOMETER SENSOR

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

DINAMAP PRO 1000 MONITOR WITH SUPERSTAT, MODEL 1000

FDA 510(k)
FDA Class 2 ·Cardiovascular

INFINITI VISION SYSTEM

FDA Adverse Event
Injury ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·October 17, 2008

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

KINETRA

FDA Adverse Event
Death ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·July 2, 2013

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