14 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MIIG II BONE GRAFT SUBSTITUTE
FDA 510(k)
FDA Class 2
·Orthopedic
OneTouch Verio Flex
FDA UDI
LifeScan Europe GmbH·00353885012799·OneTouch Verio Flex Blood Glucose Monitoring Sy...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197152112·Vise Micro Suture Tying Forceps
straig...
ENDOSCOPIC CAMERA MC404/C3
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NOVABONE-RESORBABLE BONE GRAFT SUBSTITUTE
FDA 510(k)
FDA Class 2
·Orthopedic
DEVICE 8252410 NIM-NEURO 2.0 INTERFACE
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code IKN·February 21, 2014
UNK PERCLOSE
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code MGB·March 24, 2026
VALIANT CAPTIVIA THORACIC STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·March 27, 2013
CAPSURE SENSE
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·March 18, 2011
CLEARSTAR PUMP
FDA Adverse Event
Malfunction
·ROSS PRODUCTS DIVISION·Product code LZH·April 3, 2008
LOGIC TIBIA PS MOD INSRT SZ 2 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 14, 2024
HEARTMATE 3 LVAS IMPLANT KIT
FDA Adverse Event
Death
·THORATEC CORPORATION·Product code DSQ·December 8, 2021
Brand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number: EG-111 Software Version: N/A Product Description: These bottles are sold empty and are filled by the user with water - in some cases small quantities of disinfectant solutions - for dental treatments. The bottle is pressurized on the device during use. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
FDA Enforcement
Class II
·Ongoing·Electro Medical Systems SA·May 1, 2024
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