13 results
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20ms
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Sources: EU EUDAMED, US FDA
PATHWAY PV ATHERECTOMY SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
CoRoent
FDA UDI
Nuvasive, Inc.·00887517284235·CoRoent® Large MP, 13x9x28 8°
TASMIN R 8°
FDA UDI
SIGNUS Medizintechnik GmbH·04047844014820·The basic shape of the TASMIN R devices is a ho...
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810057371127·STRETCHER PAD 24" W X 2" H X 74" L DELUXE
Deploy™ Expandable Interbody System
FDA UDI
Southern Spine LLC·00815351023031·Lumbar Expandable Cage, 8 Degree, 28mm Length, ...
INTRODUCER SHEATH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH
FDA 510(k)DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 8, 2024
VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code MMI·April 26, 2013
ITREL 3
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·July 24, 2008
DUROM US ACETABULAR COMPONENT 52/46 L
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·April 28, 2011
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
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018