31 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AxSOS 3 Ti Locking Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
MAXIM® VI KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00887868225857·
MAXIM VI KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304205789·
ALEUTIAN SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
PASS LP
FDA Adverse Event
Injury
·MEDICREA INTERNATIONAL·Product code MNI·July 12, 2013
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·March 3, 2026
PASS LP
FDA Adverse Event
Injury
·MEDICREA INTERNATIONAL·Product code MNI·July 12, 2013
ZEPHYR XL DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, CRMD·Product code DXY·January 13, 2014
HEARTMATE II LVAD
FDA Adverse Event
Death
·THORATEC CORP.·Product code DSQ·May 30, 2013
VC EVH, OD, SMR, VD, BP
FDA Adverse Event
Other
·SORIN GROUP USA, INC.·Product code GEI·June 17, 2011
PASS LP
FDA Adverse Event
Injury
·MEDICREA INTERNATIONAL·Product code MNI·July 12, 2013
PASS LP
FDA Adverse Event
Injury
·MEDICREA INTERNATIONAL·Product code MNI·July 12, 2013
PASS LP - LIAPASS
FDA Adverse Event
Injury
·MEDICREA TECHNOLOGIES·Product code MNI·March 29, 2013
KIT VERITOR FLU HOSPITAL 30 TEST JAPAN
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·March 19, 2021
PKG., 3MM INSERT, BABCOCK FORCEPS, 29CM, P/N 0250282103 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·October 7, 2025
TECNIS
FDA Adverse Event
Injury
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code HQL·September 6, 2018
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 24, 2026
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 24, 2026