11 results
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18ms
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Sources: EU EUDAMED, US FDA
POPMESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Premier H-FILES
FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·D6919053424·FILES HEDSTROM PKG 6 25MM 08
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809842227·FOR MEN 30-40 MM HG KNEE HIGH OPEN TOE LARGE FU...
INTRAMEDULLARY FIXATION SYSTEM FOR THE HAND
FDA 510(k)
FDA Class 2
·Orthopedic
PINNACLE R/O II OR RADIFOCUS INTRODUCER II
FDA 510(k)
FDA Class 2
·Cardiovascular
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·April 11, 2013
ELECTRODE, ELECTROCARDIOGRAPH
FDA Adverse Event
Malfunction
·UNOMEDICAL, LTD·Product code DRX·March 17, 2011
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Death
·CORDIS LLC (PR)·Product code NIQ·May 27, 2008
MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195028 MS-00009 (Pack of 10) - MOLLI Introducer (12cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195134 MP2001 - MOLLI 2 Wand UDI (GTIN): 00850024195141 MP2015A - MOLLI OncoPen UDI (GTIN): 00850024195219 MT2001 - MOLLI 2 Tablet UDI (GTIN): 00850024195158 The MOLLI Marker is intended to be placed percutaneously in soft tissue to temporarily mark a surgical site intended for surgical removal. the MOLLI Marker is located and surgically removed with the target tissue.
FDA Enforcement
Class II
·Ongoing·Stryker Corporation·February 25, 2026
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
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026