12 results · 19ms · 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.

DISCOVERY MODEL NM/CT 670

FDA 510(k)
FDA Class 2 ·Radiology

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690198338·AK3 PS Insert Trial Size 5, 14mm

LEONE SPA

FDA UDI
LEONE SPA·08033707065890·EXTRAORAL ELASTICS 3/8" 14 oz

PHSL-63 PEDIATRIC HEAD AND SPINE ARRAY COIL

FDA 510(k)
FDA Class 2 ·Radiology

ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200

FDA 510(k)
FDA Class 2 ·Radiology

EDWARDS ESHEATH INTRODUCER SET

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code NPT·December 6, 2021

EDWARDS TF SHEATH UNKNOWN

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code NPT·October 30, 2021

ACCESS

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MALTA·Product code FPA·May 6, 2013

HARMONIC SYNERGY* CURVED BLADE

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·September 16, 2014

GREENLIGHT ADDSTAT

FDA Adverse Event
Malfunction ·AMS, INNOVATION CTR - SILICON VALLEY·Product code GEX·April 6, 2011

Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-33, c) 44, 47, 50, 53 head, Large, Item Number 314-02-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-35; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 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