17 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SW
FDA UDI
SW SAFETY SOLUTIONS INC.·00616489125556·PowerChem Neoprene Exam Gloves, Extra Large
PROBE HOLDER SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SW
FDA UDI
SW SAFETY SOLUTIONS INC.·00616489105657·PowerChem Neoprene Exam Gloves, Extra Large
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481113277·LOCATOR R-Tx Abutment for 5.5mm XiVE Connection...
EXEL INJECTION PLUG WITH CAP
FDA 510(k)
FDA Class 2
·General Hospital
ASPIRATION PUMP, MODEL IMD-020
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PINNACLE MTL INS NEUT40IDX58OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·April 22, 2013
PINNACLE SECTOR II CUP 60MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·April 13, 2011
ACCU-CHEK RAPID D INFUSION SET
FDA Adverse Event
Injury
·DISETRONIC MEDICAL SYSTEMS·Product code FPA·July 7, 2008
CORMATRIX ECM FOR PERICARDIAL CLOSURE
FDA Adverse Event
Injury
·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·October 26, 2011
CORMATRIX ECM FOR PERICARDIAL CLOSURE
FDA Adverse Event
Injury
·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·October 30, 2013
CORMATRIX ECM FOR PERICARDIAL CLOSURE
FDA Adverse Event
Injury
·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·April 14, 2015
CORMATRIX ECM FOR PERICARDIAL CLOSURE
FDA Adverse Event
Injury
·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·May 7, 2010
Site-Rite Sterile Needle Guide Kit - 18 gauge
FDA Recall
Terminated
·Bard Access Systems, Inc·Product code ITX·November 3, 2004
SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm; SureT G29 6mm 32"' SureT G29 6mm, 32", Paradigm; SureT G29 8mm, 23"; SureT G29 8mm, 23", Paradigm; SureT G29 8mm, 32"; SureT G29 8mm, 32", Paradigm; SureT G29 10mm, 32", Paradigm The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
FDA Enforcement
Class II
·Terminated·Unomedical As·November 9, 2016
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
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024