22 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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K-SPRAY, MODEL 085-2715
FDA 510(k)
FDA Class 1
·Dental
OsteoMed
FDA UDI
OSTEOMED LLC·00845694000819·2.4mm x 18mm Screw
OsteoMed
FDA UDI
OSTEOMED LLC·00845694008334·2.4mm x 18mm Lag Screw
Sklar®
FDA UDI
SKLAR CORPORATION·10649111076831·PEDIATRIC DUAL STETH 30" BRGDY
OsteoMed
FDA UDI
OSTEOMED LLC·00845694035125·2.4 x 18mm Lag Screw, Sterile
OsteoMed
FDA UDI
OSTEOMED LLC·00845694066969·HPS 2.4 x 18mm Lag Screw Sterile Qty 5
OsteoMed
FDA UDI
OSTEOMED LLC·00845694062879·2.4 x 18mm Screw Sterile Qty 5
BHR MODULAR HEAD 46MM
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code KWY·January 4, 2018
DURACON TOTAL KNEE SYSTEM WITH PERI-APATITE COATING
FDA 510(k)
FDA Class 2
·Orthopedic
BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TEST, MODEL 133C AND 133D
FDA 510(k)
FDA Class 2
·Clinical Toxicology
56MM AND R3 ACETABULAR SHELL
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MBL·September 14, 2018
OT VERIO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 16, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 5, 2014
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·April 12, 2011
TAMPONADE URETERINE BALLOON CATHETER SET
FDA Adverse Event
Injury
·COOK UROLOGICAL·Product code KNA·October 16, 2007
ANGIODYNAMICS / SMART PORT
FDA Adverse Event
Malfunction
·ANGIODYNAMICS·Product code LJT·August 21, 2017
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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022