15 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AUTOSUTURE ENDO GIA SINGLE USE BLACK RELOAD WITH TRI-STAPLE TECHNOLOGY
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198215·AK3 PS Insert Trial Size 4, 10mm
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0134100·Trial, TLIF, 27L OB STR 7Deg, 10mm
ROCCIA
FDA UDI
Silony Medical GmbH·04054896028194·ROCCIA MultiLIF Cage 9 x 34 mm, 10° Lor.
OMEGALIF
FDA UDI
SPINAL ELEMENTS·00840916133245·OMEGA XP™ 9MM X 34MM X 10MM 3° C
AT HOME DRUG TEST, MODEL 9064
FDA 510(k)
FDA Unclassified
·Unknown
CONCENTRIC RETRIEVER, MODEL 90030
FDA 510(k)
FDA Class 2
·Cardiovascular
TRILOGY 200
FDA Adverse Event
Malfunction
·RESPIRONICS INC·Product code CBK·August 19, 2020
INTIMA-II Y 24GAX0.75IN PRN/EC SLM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·February 10, 2021
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 26, 2013
RESTORE SENSOR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·September 16, 2014
PLMA DVC V11.51 1 N
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA, LTD.·Product code FRN·April 12, 2011
MDLR CNLTD TRIDRV DRVR
FDA Adverse Event
Malfunction
·EXACTECH, INC.·Product code LXH·August 29, 2023
XP-XP Tibial Tray - Interlok 73 mm Item # 195756
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
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