18 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TROJAN NIRVANA COLLECTION LUBRICATED CONDOMS
FDA Adverse Event
Injury
·CHURCH & DWIGHT CO., INC.·Product code HIS·June 24, 2020
TROJAN-ENZ LUBRI. CONDOMS (MODIFIED LABELING)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
KENSEY NASH P1076 COLLAGEN DENTAL MEMBRANE, MODEL 20655-XX
FDA 510(k)
FDA Class 2
·Dental
SELF ADHERING NAVIGUS GUIDE
FDA 510(k)
FDA Class 2
·Neurology
OT ULTRAMINI METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 30, 2014
INTEGRATED APD SET W/CASSETTE3-PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 17, 2010
PELVICOL ACELLULAR COLLIGEN MATRIX
FDA Adverse Event
Injury
·COVIDIENT, FORMERLY TISSUE SCIENCE·Product code FTL·November 7, 2012
NDLE 18GA 1-1/2IN BLT FILL NC TW SHLD
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·March 28, 2019
PINNACLE MTL INS NEUT36IDX52OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·February 7, 2013
5.0MM DIA TPRD HD PER SCRW 35
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·May 23, 2013
5.0MM DIA TPRD HD PER SCRW 30
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·May 23, 2013
PINN CAN BONE SCREW 6.5MMX40MM
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIV. OF DEPUY - REG. # 1219655·Product code NDJ·May 23, 2013
PINN CAN BONE SCREW 6.5MMX20MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·May 23, 2013
PINN CAN BONE SCREW 6.5MMX25MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·May 23, 2013
PINNACLE SECTOR II CUP 52MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·May 23, 2013
PINN CAN BONE SCREW 6.5MMX20MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code NDJ·May 23, 2013
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