17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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POLYSORB* SYNTHETIC ABSORBABLE SUTURE WITH MODIFIED PACKAGING
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HARDYDISK NAFCILLIN, 1 MCG
FDA 510(k)
FDA Class 2
·Microbiology
EMTRAC; DELPHIN; SEMTRAC 2000 SET
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
STRATUS CS
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code DAP·November 11, 2015
STRATUS CS
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code DAP·November 9, 2015
CR TIBIAL INSERT SZ 5, 13MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·October 28, 2024
METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 48, 42,CODE H
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·June 19, 2018
EASYPUMP II LT 100-50-S
FDA Adverse Event
Malfunction
·B. BRAUN MEDICAL PRODUCTION LTD.·Product code MEB·April 12, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·April 19, 2011
BLACKMAX SYSTEM MOTORS
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code HBB·June 19, 2008
METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 54, 48, CODE N
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·March 28, 2019
METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 50, 44, CODE J
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·February 20, 2018
METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 50, 44, CODE J
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·February 20, 2018
METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 46/ 40, CODE F
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·June 13, 2018
METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 62/56, CODE V
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·January 31, 2018
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