14 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
TALON INFUSION SET, MODEL IP XXXX
FDA 510(k)
FDA Class 2
·General Hospital
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033290·Baltic Denture System BDLoad BDLoad Lm6 PLSEbi...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197256865·PAYR Pylorus Clamp with pin
290mm,...
ALPHATEC
FDA Adverse Event
ALPHATEC MFG INC. AKA NEXMED INC·Product code HWC·February 26, 2004
MODIFIED 650 MAMMOGRAPHY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
STERRAD 50 & STERRAD 100S STERILIZERS
FDA 510(k)
FDA Class 2
·General Hospital
RAD-5 PULSE OXIMETER
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code DQA·July 13, 2018
HOURGLASS
FDA Adverse Event
Injury
·MEDTRONIC·Product code MQP·June 16, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 3, 2013
STRYKEFLOW II
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS·Product code FQH·March 28, 2011
CB INFANT PACK
FDA Adverse Event
Injury
·MEDTRONIC PERFUSION SYSTEMS·Product code DTZ·April 21, 2008
HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203801
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·October 28, 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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024