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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NAVIGATOR URETERAL ACCESS SHEATH SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Graves Vu-More X Long
FDA UDI
MEDGYN PRODUCTS, INC.·M803030956·Graves Vu-More X Long 6 1/3" (161mm)
FREESTYLE GLUCOMETER AND STRIPS
FDA Adverse Event
Malfunction
·ABBOTT·Product code LFR·February 8, 2018
BARD ENDOCINCH SUTURING SYSTEM # 000452; 000454; 000595
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS
FDA 510(k)
FDA Class 2
·Cardiovascular
UNKNOWN BASEPLATE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·March 2, 2026
NC QUANTUM APEX?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·April 2, 2013
EON MINI RECHARGEABLE IPG
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·March 22, 2011
BALLOON APPLICATOR KIT 5-6 SPHERICAL
FDA Adverse Event
Malfunction
·XOFT, INC.·Product code JAQ·April 16, 2008
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018
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