61 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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InFill Interbody Fusion Devices
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04064984699588·GENUMEDI PSS BLUE, SIZE VI
Vilex Guidewire
FDA UDI
VILEX IN TENNESSEE, INC.·00841731120571·Guidewire 2.0x150mm Sgl Trocar
Vilex Guidewire
FDA UDI
VILEX IN TENNESSEE, INC.·00841731120564·Guidewire 2.0x150mm Dbl Trocar
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100097·BARRAQUER SPECULUM SOLID SMALL
CEDIA TACROLIMUS ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AESCULAP- MEITHKE SHUNT SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code ODG·July 24, 2021
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code ODG·July 21, 2021
IMPELLA CP
FDA Adverse Event
Malfunction
·ABIOMED, INC.·Product code OZD·January 7, 2026
PRODIGY AUTOCODE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD.·Product code NBW·December 27, 2016
UNK_INTRODUCER
FDA Adverse Event
Malfunction
·ABIOMED, INC. - 1220648·Product code DYB·February 6, 2026
OMNIPOD 5 POD
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code QFG·July 13, 2022
LAKE REGION 0.027" PTFE GUIDEWIRE
FDA Adverse Event
Injury
·ABIOMED, INC. - 1220648·Product code OZD·January 14, 2026
Medline Convenience kits labeled as: 1) SYR CONTROL PAD 12ML L/L, Pack Number DYNJSYR12CP; 2) MSC - AHMC ANAHEIM REG MED CTR, Pack Number 148056; 3) MSC - JOHN MUIR MC, Pack Number 150206
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024
PAINSMART IOD
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·May 28, 2013
GOBED+
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code INK·June 10, 2011
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM
FDA Adverse Event
Injury
·COSTA RICA·Product code LTI·September 3, 2008
MEDTRONIC DUAL CHAMBER TEMPORARY EXTERNAL PACEMAKER 510(K) K150246
FDA Adverse Event
Death
·MEDTRONIC, INC.·Product code DTE·February 10, 2021
OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·February 9, 2022