10,000 results
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76ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SAMBA 2 GO w/o manuals
FDA UDI
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.·09008737532925·Audio Processor Streaming Device
2010 VIDEO GUIDED CATHETER
FDA Adverse Event
Malfunction
·MYELOTEC, INC·Product code HRX·April 13, 2017
DREAMSTATION GO W/BT
FDA Adverse Event
Malfunction
·RESPORINOC INC·Product code BZD·June 30, 2021
BAXTER TUBING
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·March 30, 2023
BD PRECISIONGLIDE NEEDLE
FDA Adverse Event
Injury
·BECTON DICKINSON·Product code FMI·October 12, 2011
VISISTAT 35R 6/BOX
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code QQS·August 3, 2022
DREAMSTATION GO W/BT, AUS
FDA Adverse Event
Malfunction
·RESPORINOC INC·Product code BZD·October 6, 2021
DREAMSTATION GO W/BT, AUS
FDA Adverse Event
Malfunction
·RESPORINOC INC·Product code BZD·October 6, 2021
V-GO DISPOSABLE INSULIN DELIVERY DEVICE
FDA Adverse Event
Malfunction
·ZEALAND PHARMA U.S. INC.·Product code LZG·February 22, 2021
BREATHING CIRCUIT SET
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code BZO·May 26, 2026
EUFLEXXA
FDA Adverse Event
Injury
·BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.·Product code MOZ·January 29, 2013
PUMP IN STYLE WIC BREAST PUMP GO W/O BATTERY
FDA Adverse Event
Malfunction
·MEDELA, INC.·Product code HGX·December 18, 2014
REAMER HEAD F/RIA 2 Ø10
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HTO·February 26, 2024
TECNIS ITEC PRELOADED 1-PIECE IOL
FDA Adverse Event
Malfunction
·JOHNSON AND JOHNSON SURGICAL VISION·Product code HQL·September 18, 2018
AQUACEL EXTRA
FDA Adverse Event
Malfunction
·CONVATEC LTD·Product code NAC·March 19, 2026
PREMIUM ARTHROSCOPY PACK - CUSTOMED- (1) ARTHROSCOPY SHEET T WITH POUCH LIF (1) IMPERVIOUS STOCKINETTE (3) STRIPS TAPE 24" X 4" (1) DRAPE U WITH TAPE SPLIT (2) TOWELS ABSORBENT 15" X 20" LIF (1) GOWN IMPERVIOUS REINFORCED X-LARGE SMS (1) GOW SURG. REINFORCED LARGE TOWEL/WRAP (1) TABLE COVER REINFORCED 50" X 90" LIF (1) MAYO STAND COVER REINFORCED LIF (1) CONTAINER SPECIMEN 4oz WITH LID & LABEL (1) TUBE SUCTION CONNECT. }4" X 12' LIF (1) SURGICAL BLADE #11 CARBON STEEL (1 ELASTIC BANDAGE 6" X 5 YRD. L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
INTELLIS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·December 16, 2025
HEATER-COOLER SYSTEM 3T
FDA Adverse Event
Injury
·LIVANOVA DEUTSCHLAND·Product code DWC·April 7, 2022
VISISTAT 35R 6/BOX
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code QQS·August 3, 2022
MAKO ROBOTIC ARM 3.1
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·April 10, 2023