14 results · 20ms · Sources: EU EUDAMED, US FDA

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SYNTHASOME X-REPAIR

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

OMEGATRAC, MODEL Z105

FDA 510(k)
FDA Class 2 ·Physical Medicine

DERMAGRIP POWDER FREE PINK POLYMER COATED LATEX EXAMINATION GLOVE, NON-STERILE CONTAINS 50 MICROGRAMS OR LESS OF TOTAL W

FDA 510(k)
FDA Class 1 ·General Hospital

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

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·April 29, 2013

PRECISION XTRA

FDA Adverse Event
Malfunction ·Product code NBW·May 10, 2011

J-VAC RESERVOIR

FDA Adverse Event
Malfunction ·ETHICON, INC.·Product code GCY·July 25, 2008

PASS LP - LIAPASS

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

INFOV.A.C. THERAPY SYSTEM

FDA Adverse Event
Injury ·KINETIC CONCEPTS, INC·Product code OMP·March 4, 2021

Icy Hot Heat Therapy , Air Activated Heat Patch, Back and Large Areas, UPC Code 0-41167-08330-7, Product Code 08330, 4.1" x 8.4" (10.5 cm x 2.1 cm) each, 1 and 3 count patches, Distributed by Chattem, Inc. P.O. Box 2219, Chattanooga, TN 37409-0219

FDA Recall
Terminated ·Chattem Inc·Product code IMD·February 12, 2008

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