20 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
D-Fine Double Diamond™ Final High Shine Refill #04
FDA UDI
DEN-MAT HOLDINGS, LLC·00359883003685·Dental burnisher
D-Fine Double Diamond™ Final High Shine Refill #04
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172001915·Dental burnisher
STILLE Various Instruments
FDA UDI
Stille AB·07332339210496·SOFT PROFILES for PLASTER CAST REMOVER STILLE 1...
Batrik Arc Wire Brushes Single Use
FDA UDI
Batrik Medical Manufacturing Inc·00690521008151·Brush/Green/BD 4mm/BL 25mm/OL 30cm - Flexible -...
STILLE Various Instruments
FDA UDI
Stille AB·07332339210502·SOFT PROFILES for PLASTER CAST REMOVER STILLE 1...
K2M General Instruments
FDA UDI
VB Spine LLC·10888857561410·Parallel Rasp Size 12x12x7 mm
FEMORAL HEADS, 2.5 AND 7.5 MM NECK LENGTH
FDA 510(k)
FDA Class 2
·Orthopedic
ARTHROCARE SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
UniTip Catheter
FDA UDI
Unisensor AG·07640172973684·
BD PERFUSION 50 ML SYRINGE WITH MOUNTED NEEDLE, OPAQUE
FDA Adverse Event
Malfunction
·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code FMF·January 24, 2022
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 1, 2014
UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·May 29, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 17, 2011
RAD AIMING ARM/FRN GREATER TROCHANTER
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·October 13, 2021
PINNACLE SECTOR II CUP 56MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·June 9, 2011
ARTICULEZE M HEAD 36MM +8.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·June 12, 2013
Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016A Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No
FDA Enforcement
Class I
·Ongoing·Edwards Lifesciences, LLC·July 16, 2025
BBL Brain Heart Infusion Agar CC w/Sheep Blood - Catalog Number 296178.
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code JSO·July 2, 2004
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024