14 results
·
27ms
·
Sources: EU EUDAMED, US FDA
OB-1 FETAL MONITOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
IMPACT-PLUS
FDA UDI
Denplus Inc·D8451011304·IMPACT-PLUS, SPI, 11.3 kg
Zirlux
FDA UDI
HENRY SCHEIN, INC.·H65890113040·Zirlux Titanium Blank Abutment compatible with:...
MASEL
FDA UDI
Ortho Organizers, Inc.·00190707053789·GeoShapes™ Elastics 5/16" (7.94 mm) Medium 3.5...
Ovation Tribute Hip Stem
FDA UDI
Ortho Development Corporation·00822409011254·EXT SIZE 4 Stem Plasma Spray
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0112040·Tap, 5.50mm
MXR-2000 MOBILE X-RAY UNIT
FDA 510(k)
FDA Class 2
·Radiology
NEEDLELOK HYPODERMIC NEEDLE PROTECTION
FDA 510(k)
FDA Class 2
·General Hospital
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·July 26, 2019
JUGGRKNOT 2.9MM 2 #2MB BLUE
FDA Adverse Event
Injury
·BIOMET SPORTS MEDICINE·Product code MBI·March 19, 2013
ASR ACETABULAR IMPLANT 58
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD - 8010379·Product code KWA·March 4, 2011
ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT OTW
FDA Adverse Event
Malfunction
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·March 11, 2008
Amvisc Intraocular Injection Sodium hyaluronate 12 mg/ml For European Distribution Manufactured for Bausch & Lomb Surgical,Irvine,CA and
FDA Recall
Terminated
·Anika Therapeutics·Product code LZP·October 8, 2003
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