15 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
UCR SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Symmetry Nelson
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482051436·Symmetry® Scissors, Nelson Metzenbaum Dissectin...
ZAAG
FDA UDI
Zest Anchors, LLC·00840481109225·ZAAG Implant Cap Male (Standard) (2 Pack)
RS NITRILSTAT MEDICAL EXAMINATION GLOVES, POWDER FREE (NON-STERILE)
FDA 510(k)
FDA Class 1
·General Hospital
CYBERCASES BY BAUSCH & LOMB
FDA 510(k)
FDA Class 2
·Ophthalmic
HNM Medical
FDA UDI
HNM STAINLESS, LLC.·00842962107492·NELSON METZENBAUM DISSECTING SCISSORS, 12", STR
BONE SCREW SELF-TAPPING 6.5 MM DIA. 70 MM LENGTH
FDA Adverse Event
Malfunction
·ZIMMER MANUFACTURING B.V.·Product code LPH·May 5, 2023
COGNIS
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 9, 2013
LC PCA III INFUSER
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code MEA·February 24, 2011
THINLINE II STEROX
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008
ARCHITECT IPTH REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code CEW·March 19, 2025
ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required.
FDA Enforcement
Class II
·Terminated·Arjo Hospital Equipment AB·October 15, 2014
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
Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify Assura, Model Numbers: CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q; Quadra Assura, Model Numbers: CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q; Quadra Assura MP, Model Numbers: CD3269-40, CD3269-40Q, CD3369-40C, CD3369-40Q Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing
FDA Enforcement
Class I
·Terminated·St Jude Medical Inc.·October 18, 2017
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018