21 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Trial Tibial Augment
FDA UDI
ADLER ORTHO SPA·08056269044196·TRIAL PANTHEON TIBIAL AUGMENT RM/LL SIZE 6 H5
Sub-Coracoid Clip - Small, Rectangle, Curved
FDA UDI
Cc-Instruments Inc.·G523T1005260·Sub-Coracoid Clip - Small, Rectangle, Curved
COOLEY PEDIATRIC VASCULAR CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896002616·COOLEY PEDIATRIC VASCULAR CLAMP DELICATE DOUBLE...
COOLEY PEDIATRIC VASCULAR CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·B09921005260·COOLEY PEDIATRIC VASCULAR CLAMP DELICATE DOUBLE...
Tungst.Carb.Burr,Ø0.5x70mm,50k
FDA UDI
Bien-Air Surgery SA·07630055506672·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450229675·
HARDYDISK, CEPHALOTHIN 30MCG
FDA 510(k)
FDA Class 2
·Microbiology
MODIFICATION TO THE GRIP
FDA 510(k)
FDA Class 2
·Cardiovascular
O3 PEDIATRIC SENSOR
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code MUD·August 20, 2022
O3 PEDIATRIC SENSOR
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code MUD·August 19, 2022
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·May 8, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 19, 2014
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·May 13, 2011
ROOT
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code MWI·September 20, 2018
MICROCLAVE CLEAR CONNECTOR
FDA Adverse Event
Malfunction
·ICU MEDICAL, INC.·Product code FPA·June 5, 2014
LATITUDE ELBOW ANATOMIC HUMERAL SPOOL SZ PETIT+ SIDE GAUCHE
FDA Adverse Event
Injury
·TORNIER INC·Product code JDC·May 7, 2024
Vertex Max Drill Guide, Catalog Number 9732355, to be used with a Medtronic Computer-Assisted Surgery System to help assist with screw placement during spine procedures. To be used with a Medtronic Computer-Assisted Surgery System to help assist with screw placement during spine procedures.
FDA Recall
Terminated
·Medtronic Navigation, Inc·Product code HAW·September 24, 2010
Latex Rebreathing Bags: Product Code Equivalent Code (a) 151174050 151174 (b) 153000005 153000005 (c) 153000010 153000010 (d) 153000020 153000020 (e) 153000030 153000030 (f) 153000050 153000050 (g) 210700050 2107050 (h) 210700102 2107102 (I) 210700202 2107202 (j) 210700302 2107302 (k) 210700402 2107402 (l) 210700502 2107502 (m) 210700602 2107602 Product Usage: Rebreathing Bag is indicated for manual patient ventilation or in connection with anaesthesia apparatus and/or patient ventilators.
FDA Enforcement
Class II
·Terminated·Teleflex Medical Europe Ltd·April 18, 2018
CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).
FDA Enforcement
Class II
·Terminated·CME America, LLC·December 9, 2020