18 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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CP-3 DENTAL POLISHING MATERIAL
FDA 510(k)
FDA Class 1
·Dental
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR METHAMPHETAMINE AND 4-METHYLENEDIOXYMETHAMPHETAMINE (MDMA)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
METASUL TAPER LINERS, METASUL FEMORAL HEADS
FDA 510(k)
FDA Class 3
·Orthopedic
RESTORE RECHARGABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·November 12, 2010
MALLINCKRODT
FDA Adverse Event
Malfunction
·COVIDIEN·Product code BTR·February 21, 2014
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·November 21, 2012
METASUL LDH, HEAD, 56, CODE V, TAPER 18/20
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·April 27, 2018
METASUL LDH, HEAD, 56, CODE V, TAPER 18/20
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWY·January 31, 2018
METASUL LDH, HEAD, 40, CODE F, TAPER 18/20
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·June 13, 2018
METASUL LDH, HEAD, 44, CODE J, TAPER 18/20
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KXA·October 24, 2017
METASUL HEAD 28MM L 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·August 7, 2018
METASUL HEAD 28MM L 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·August 3, 2018
METASUL, HEAD, M, 32/0, TAPER 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·March 12, 2018
METASUL LDH, HEAD, 44, CODE J, TAPER 18/20
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·February 22, 2018
ECHO BI-MTRC MICR RP SO 5X73
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·June 6, 2018
METASUL LDH, HEAD, 44, CODE J, TAPER 18/20
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·June 14, 2018
METASUL LDH, HEAD, 48, CODE N, TAPER 18/20
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·May 18, 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