19 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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YSIO X.pree
FDA 510(k)
FDA Class 2
·Radiology
NuVasive
FDA UDI
Nuvasive, Inc.·00195377046338·NTS Standard Tube, 16x70mm
Dornier MedTech
FDA UDI
DORNIER MEDTECH AMERICA, INC.·00810116023462·THULIO LL-R TM 270µM 3M SLIM PERF. 3ST 10X USE
CODMAN
FDA UDI
Cerenovus, Inc.·10886704001560·CODMAN SLIM-LINE Aneurysm Clip 30 Degree Forwar...
NA
FDA UDI
Synthes GmbH·10886982142351·2.4MM CORTEX SCREW SELF-TAPPING 40MM
N/A
FDA UDI
HANS RUDOLPH, INC.·00874750005567·HEADGEAR LARGE HC QUEST SERIES
Blade Handle
FDA UDI
KATENA PRODUCTS, INC.·00841668112397·BARD-PARKER HANDLE #9
Zodiac
FDA UDI
ALPHATEC SPINE, INC.·00844856044548·TI ILIAC BONE SCREW ASSY, 7.5MM X 70MM X 15°
Zodiac
FDA UDI
ALPHATEC SPINE, INC.·00844856044555·TI ILIAC BONE SCREW ASSY, 7.5MM X 70MM X 30°
UNITED U2 BIPOLAR IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-757
FDA 510(k)
FDA Class 2
·Cardiovascular
AQUACEL AG SURGICAL
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code FRO·May 3, 2024
MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S -4
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·September 12, 2022
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 15, 2011
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 27, 2014
840 VENTILATOR
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY NELLCOR·Product code CBK·June 28, 2013
CAPSUREFIX NOVUS LEAD MRI SURESCAN
FDA Adverse Event
Injury
·MPRI·Product code DTB·August 11, 2011
CUP: MPACT ACETABULAR SHELL Ø52 TWO-HOLES
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·April 10, 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