15 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKS
FDA 510(k)
FDA Class 2
·Anesthesiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526827936·ACHIMED ACHILLES SUPP BLACK V
ISOLA
FDA UDI
DEPUY SPINE, LLC·10705034004525·ISOLA SPINE SYSTEM MCC PLATE 0-15mm
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526827875·***DISC*LEVAMED ANKLE SUPPORT BLACK V
i-ED COIL
FDA UDI
KANEKA CORPORATION·04540778177314·The i-ED COIL is used for vascular embolization...
Symmetry Surgical
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482051061·Symmetry® Scissors, Operating, Curved, Sharp/Sh...
NITINOL TC ELECTRODE
FDA Adverse Event
Malfunction
·COSMAN MEDICAL·Product code GXI·August 24, 2017
ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200
FDA 510(k)
FDA Class 2
·Radiology
PRO OSTEON 200R RESORBABLE BONE GRAFT SUBSTITUTE, MODELS 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150,
FDA 510(k)
FDA Class 2
·Orthopedic
ROTALINK? BURR
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - CORK·Product code MCX·April 2, 2013
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·March 22, 2011
SILICONE ADVANCED OPTIC-VIOLET SHIELD
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code HQL·April 17, 2008
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
Cocoon Convective Warming System, Product Code: CWS4000 (110V).
FDA Enforcement
Class II
·Terminated·Care Essentials Pty., Ltd.·February 12, 2020
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