21 results
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23ms
·
Sources: EU EUDAMED, US FDA
Atalante X
FDA 510(k)
FDA Class 2
·Physical Medicine
Bosma Enterprises
FDA UDI
Bosma Enterprises·00818634025470·Opportunity Flex Nitrile Exam Glove Extra Large...
Bradshaw Medical Inc.
FDA UDI
Bradshaw Medical, Inc.·00810019931314·BIT, INT.SCREW REMOVER 7.0MM 1/4 SQ
Life Instruments
FDA UDI
Life Instrument Corporation·M930525090410·Pedicle Probe slight curve
Life Instruments
FDA UDI
Life Instrument Corporation·M930525090400·Penfield Pedicle Probe 10" 4mm Flat
Life Instruments
FDA UDI
Life Instrument Corporation·M93052509040D0·Pedicle Probe delicate
CPAP HUMIDIFIER, MODEL HC238JHU
FDA 510(k)
FDA Class 2
·Anesthesiology
Tosoh Automated Glycohemoglobin Analyzer HLC-723G8
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ADVANTA BED
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·December 2, 2008
ALARIS
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·August 29, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 29, 2013
LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 11MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·July 31, 2024
HLC-723 G8
FDA Adverse Event
Malfunction
·TOSOH HI-TEC, INC.·Product code PDJ·July 26, 2024
G8
FDA Adverse Event
Malfunction
·TOSOH HI-TEC, INC.·Product code PDJ·August 27, 2025
BFLEX 2 REGULAR 5.0 SINGLE-USE BRONCHOSCOPE
FDA Adverse Event
Malfunction
·VERATHON MEDICAL ULC·Product code EOQ·August 5, 2025
DEX Ophthalmic Tissue Forceps, 25ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-25
FDA Enforcement
Class II
·Ongoing·Katalyst Surgical, LLC·May 13, 2026
DEX Ophthalmic Tissue Forceps, 23ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-23
FDA Enforcement
Class II
·Ongoing·Katalyst Surgical, LLC·May 13, 2026
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-25-S
FDA Enforcement
Class II
·Ongoing·Katalyst Surgical, LLC·May 13, 2026
DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-27
FDA Enforcement
Class II
·Ongoing·Katalyst Surgical, LLC·May 13, 2026
BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 13 X 145 MM, 57 MM, Silicone, Sterile, Item 431213.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020