18 results · 23ms · Sources: EU EUDAMED, US FDA

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POWDER FREE NITRILE EXAMINATION GLOVES, STERILE WITH CHEMOTHERAPY CLAIM

FDA 510(k)
FDA Class 1 ·General Hospital

NOBELACTIVE INTERNAL RP 4.3X8.5MM

FDA Adverse Event
Injury ·NOBEL BIOCARE AB·Product code DZE·August 17, 2020

NOBELACTIVE INTERNAL NP 3.5X8.5MM

FDA Adverse Event
Injury ·NOBEL BIOCARE AB·Product code DZE·September 9, 2020

NOBELACTIVE INTERNAL NP 3.5X8.5MM

FDA Adverse Event
Injury ·NOBEL BIOCARE AB·Product code DZE·September 9, 2020

NOBELACTIVE INTERNAL RP 4.3X8.5MM

FDA Adverse Event
Injury ·NOBEL BIOCARE AB·Product code DZE·August 17, 2020

PEDIATRIC INGESTASCAN

FDA 510(k)
FDA Class 2 ·Ophthalmic

ENOXAPARIN TEST CARD

FDA 510(k)
FDA Class 2 ·Hematology

PASS LP

FDA Adverse Event
Injury ·MEDICREA TECHNOLOGIES·Product code MNI·April 17, 2013

PASS LP

FDA Adverse Event
Injury ·MEDICREA·Product code MNI·April 17, 2013

6.0MM TI CANN MATRIX POLYAXIALSCREW 45MM THREAD LENGTH

FDA Adverse Event
Malfunction ·SYNTHES BRANDYWINE·Product code NKB·April 29, 2013

RESERVOIR 3CC

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code FRN·April 13, 2011

ACCU-CHEK SPIRIT

FDA Adverse Event
Injury ·DISETRONIC MEDICAL SYSTEMS·Product code LZG·July 28, 2008

PASS LP - LIAPASS

FDA Adverse Event
Injury ·MEDICREA TECHNOLOGIES·Product code MNI·March 29, 2013

UNKNOWN_NEUROVASCULAR_PRODUCT

FDA Adverse Event
Injury ·CONCENTRIC MEDICAL·Product code NRY·December 14, 2012

Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925754335.

FDA Recall
Terminated ·Smiths Medical PM, Inc.·Product code DPS·March 16, 2005

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 CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024

Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018