24 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AMSURE FOLEY CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Latitude™ EV
FDA UDI
TORNIER, INC.·00846832002573·Ulnar Stem - Coated
SOLID CANCELLOUS LAG SCREW
FDA UDI
Biomet Orthopedics, LLC·00887868005794·
Asnis
FDA UDI
Stryker GmbH·07613154578047·CANNULATED SCREW
Mariner Outrigger
FDA UDI
Seaspine Orthopedics Corporation·10889981174873·Z-Rod, Dia. 5.5mm, Titanium, 120mm
SCFE Screw
FDA UDI
ORTHOPEDIATRICS CORP.·00841132114322·4.0mm X 20mm FULL THREAD CANNULATED SCREW
PRO-TORQ
FDA 510(k)
FDA Class 1
·Dental
MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C
FDA 510(k)
FDA Class 2
·Hematology
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·April 11, 2022
75MM SELECTABLE NEW TLC
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·April 2, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·March 26, 2011
HAKIM VALVE
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC./ MEDOS S.A.·Product code JXG·April 14, 2008
BABY CONTROL COSYCOT INFANT WARMER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code FMT·November 29, 2011
STRATAFIX SYMMETRIC PDS
FDA Adverse Event
Injury
·ETHICON INC.·Product code NEW·October 28, 2024
VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·October 28, 2024
PDS LL PLUS ANTIBACTERIAL SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code NEW·October 28, 2024
HANDPIECE MICS
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·February 3, 2020
HANDPIECE MICS
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·December 2, 2019
Instructions For Use document of the GPS Trackers.
FDA Enforcement
Class II
·Terminated·Blue Ortho·November 4, 2020
Aqauapak 728 SW, 760 ML W/028 Adaptor, Intl, Product No. 403728; Aqauapak 1028 SW, 1070 ML/W028 Adaptor, Intl, Product No. 404128; Aqauapak 428 SW, 440 ML W/028 Adaptor, Intl, Product No. 404428; Aquapak 728 SW, 760 ML W/028 Adaptor, Product No. 037-28; Aquapak SW/EAU Sterile, 760 ML W/Adaptor, Product No. 037-28C; Aquapak 728 SW, 760 ML W/28 Adaptor, French, Product No. 037-02F; Aquapak 733 SW, 760 ML W/033 Adaptor, Product No. 037-33; Aquapak 735 HNS, 760 ML W/028 Adaptor, Product No. 037-35; Aquapak 739 FNS, 760 ML W/028 Adaptor, Product No. 037-39; Aquapak 0.9% NACL, 760 ML W/Adaptor, Product No. 037-39C; Aquapak 770 HNS, 760 ML W/033 Adaptor, Product No. 037-70; Aquapak 1028 SW, 1070 ML W/028 Adaptor, Product No. 041-28; Aquapak SW/EAU Sterile, 1070 ML W/Adaptor, Product No. 041-28C; Aquapak 1033 SW, 1070 ML W/033 Adaptor; Product No. 041-33; Aquapak 1035 HNS, 1070 ML W/028 Adaptor, Product Code 041-35; Aquapak 428 SW, 440 ML W/028 Adaptor, Product No. 044-28; Aquapak SW/EAU Sterile, 440 MLW/Adaptor, Product No. 044-28C; Aquapak 428 SW, 440 ML W/028 Adaptor, French, Product No. 044-28F; Aquapak 433 SW, 440 ML W/033 Adaptor, Product No. 044-33; Aquapak 435 HNS, 440 ML W/028 Adaptor, Product No. 044-35; Aquapak 470 HNS, 440 ML W/033 Adaptor, Product No. 044-70. Used in anesthesiology.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·December 10, 2014