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

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STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES)

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

SureFlex

FDA UDI
AMERICAN MEDICAL SYSTEMS·00878953000145·200 µm Lithotripsy Fiber

Diamond D

FDA UDI
Keystone Industries·H66810130591·Denture Acrylic SC Lrp Pwd

FOSTER GRANT

FDA UDI
FGX INTERNATIONAL INC.·00193033454206·

ENGPLUS

FDA 510(k)
FDA Class 2 ·Neurology

LASER 4SPSC340

FDA 510(k)
FDA Class 2 ·Physical Medicine

G7 PPS LTD ACET SHELL 48C

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code PBI·October 15, 2020

INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT

FDA Adverse Event
Injury ·ALLERGAN (COSTA RICA)·Product code FTR·November 21, 2024

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 1, 2013

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Other ·INVACARE·Product code CAW·March 1, 2011

12MM PRESS FIT FLUTED STEM

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code KRO·August 15, 2014

G7 VIT E NEUTRAL LNR 32MM C

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LPH·October 15, 2020

AVENIR CMPL HA HO COL SIZE 4

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LZO·October 15, 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

Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

FDA Enforcement
Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014

Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018