18 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EDWARDS TRANSFEMORAL BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Fuji Cervical Plate System
FDA UDI
Altus Spine, LLC·B41711402411·41mm Level 2 Cervical Plate System - Fuji
CONTIPLEX D CONTINUOUS NERVE BLOCK SET, MODEL 331687, 331686, 331685, 331680
FDA 510(k)
FDA Class 2
·Anesthesiology
N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET
FDA 510(k)
FDA Class 2
·Immunology
HISTOACRYL FLEXIBLE PACK 5
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code MPN·December 3, 2019
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code OZO·November 11, 2021
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·October 3, 2014
PROXIMA HI OFFSET R SZ 4
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD - 8010379·Product code LPH·May 31, 2013
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 26, 2011
MICRUSFRAME10 5MM X 17CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·December 15, 2022
GALAXY G3 XSFT 4MM X 10CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·December 15, 2022
GALAXY G3 XSFT 4MM X 10CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·December 15, 2022
GALAXY G3 XSFT 3MM X 6CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·December 15, 2022
GALAXY G3 XSFT 2.5MM X 3.5CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·December 15, 2022
GALAXY G3 XSFT 3MM X 8CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·December 15, 2022
Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 30, 2015
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
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51 b. NOVATION GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS, REF 130-36-52 c. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS, REF 130-40-53 d. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 4 CUPS, REF 130-40-54 e. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 5 CUPS, REF 130-40-55 f. NOVATION GXL LINER LIPPED 32MM ID, GROUP 1 CUPS, REF 132-32-51 g. NOVATION GXL LINER LIPPED 36MM ID GROUP 2, REF 132-36-52 h. NOVATION GXL LINER LIPPED 40MM ID, GROUP 3 CUPS, REF 132-40-53 i. NOVATION GXL LINER LIPPED 40MM ID, GROUP 4 CUPS, REF 132-40-54 j. NOVATION GXL LINER LIPPED 40MM ID, GROUP 5 CUPS, REF 132-40-55 k. NOVATION GXL LINER +5 LAT 40MM GROUP 3 CUPS, REF 136-40-53 l. NOVATION GXL LINER +5 LAT 40MM ID GROUP 4 CUPS, REF 136-40-54 m. NOVATION GXL LINER +5 LAT 40MM ID GROUP 5 CUPS, REF 136-40-55 n. NOVATION GXL LINER 10 DEG FACE 40MM ID, GRP 3 CUP, REF 138-40-53 o. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 4 CUP, REF 138-40-54 p. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 5 CUP, REF 138-40-55
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022