13 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
DUREX SPEARMINT SCENTED LUBRICATED LATEX CONDOM (DUREX 'TINGLING PLEASURE' CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
3M™ Unitek™ SmartClip™ MBT™
FDA UDI
3m do Brasil Ltda.·00652221003379·SmartClip(TM) Self-Ligating Bracket MBT(TM) LL5...
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809867251·FOR MEN 20-30 MM HG THIGH MICRO DOT BAND OPEN T...
MODIFICATION TO N PROTEIN STANDARD SL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
M2424A SONOS 5500/4500 DIAGNOSTIC ULTRASOUND SYSTEM, VERSION B.2. 21330A TRANSDUCER
FDA 510(k)
FDA Class 2
·Radiology
EAGLE/SWIFT PLUS, SCREW PRM, SD, 12MM
FDA Adverse Event
Malfunction
·DEPUY SYNTHES SPINE·Product code KWQ·April 9, 2013
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·April 6, 2011
VENTAK PRIZM 2 DR
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
CR VIVACIT-E 36MM BRNG STD
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBI·March 1, 2023
MINI TRAY +5MM COCR +0 OFFSET
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·March 1, 2023
PKG, 3MM INSERT, STRAIGHT NEEDLEHOLDER, 29CM, P/N 0250282061 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014
Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm, 23"; Silhouette Paradigm 13mm, 43"; Silhouette Paradigm 13mm, 32"; Silhouette Paradigm 32" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
FDA Enforcement
Class II
·Terminated·Unomedical As·November 9, 2016
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