8,071 results
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33ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ETHILON BLK 45CM M0.7::USP6/0 SGLE ARMED PS-3 PRIM MP
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code GAR·March 13, 2020
Alpha-D-Galactosidase A (Gla) Newborn Screening Test System
FDA classification
FDA Class 2
·Alpha-D-Galactosidase A (Gla) Newborn Screening Test System
4.5MM HEALIX ADVANCE¿ BR ANCHOR WITH DYNA (BLUE, WHT/BLUE/GRN, WHT/BLK)
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code MAI·October 26, 2022
GE Healthcare, Drapes and Sterile Covers PART NUMBER DESCRIPTION 00-900352-01 DRAIN BAG W/HOSE (2000/2500) 2.0 PE MATERIAL 00-900352-01-OEC STRL, BAG, DRAIN WITH PLASTIC CLIPS AND HOSE 2000,2500 00-900352-02 STRL, BAG, DRAIN WITH METAL TABS 00-900493-03 COVER DISPOSABLE X-RAY TUBE 00-900605-01 UROFAST DRAIN BAG (UROFAST ONLY) 00-900605-01-OEC STRL, BAG, DRAIN, WITH HOSE, UROFAST 00-900885-01 URO2600 DRAIN BAG 2.0 PE MATERIAL 00-900885-01-OEC STRL, BAG, DRAIN, URO2600 00-900943-01 STRL, COVER, CARM, HALF BAG, 36X80, 90,94,76 00-900974-01 STRL, DRAPING, MINI-CARM, KYBRD, BLK FTSW, 6600 00-901072-01 URO 2600 DISPOSABLES PACK 2.0 PE MATERIAL 00-901072-01-OEC STRL, PACK, DISPOSABLES, UROVIEW 2600 00-901169-01 12 TUBE DRAPE (36X36) 2.0 PE MATERIAL 00-901169-01-OEC STRL, COVER, DISPOSABLE, 12 INCH TUBE 9600 00-901268-01 DRAPE,STERIQUIK, STANDARD&SUPER- C,9600/7700 00-901390-01 STRL, DRAPING, KEYBOARD, FOOTSWITCH, 20PACK, 6600 00-901391-01 STRL, DRAPE, C-ARM ONLY, 6600 00-901392-01 STRL, COVER, KEYBOARD, 66,68 00-901501-01 9600/9800/SUPER C DISPOSABLES PACK 2.0 PE MATERIAL 00-901501-01-OEC STRL, PACK, DISPOSABLES, MODEL 9800, 20 PACK 00-901581-01-OEC STRL, COVER, DISPOSABLE, IR REMOTE, 9600, 9800 00901588-01 12 C ARM DISPOSABLES PACK 2.0 PE MATERIAL 00-901588-01-OEC STRL, PACK, DISPOSABLES, 12 INCH, 20 PACK SCD 9600 00-901761-01 STRL, DISPOSABLES PACK, UROVIEW 2800 00-901831-02 STRL, COVER, FLUOROTRAK MONITOR, DISPOSABLE BOX 10 PER PKG 00-901832-01 STRL, APIX, COVER, DISPOSABLE CONTROLPANEL COVERS, REPLACEMENT PART CASE OF 25 00-901917-01 STRL, DRAPE, C-ARM, 6800 00-901918-01 MINIVIEW 6800 C-ARM CONSUMABLES PACK GRAY FOOTSWITCH 00-901918-01-OEC STRL, DRAPE, 20 PACK, 6800 00-902752-01 STRL, RUI COVERS 25 COVERS 00-902753-01 STRL, PACK, DISPOSABLE, 9800MD, 9 INCH 20 PACKS 00-902754-01 STRL, PACK, DISPOSABLE, 9800MD, 12 INCH 20 PACKS 00-902776-01 STRL, DRAPE, VASCULAR 00-902864-01 STRL, DRAPE, HALF, C ARM, 9800 9600 00-902934-01 STRL, DRAPE, WORKSTATION, 20 PER BOX, 9900 1003135 STRL, BAG, FLAT PANEL E7009AE STRL, DRAPE, AFM/CFM PEDESTAL, 25 PER BOX E7009AF STRL, DRAPE, AFM/CFM JOYSTICK, 50 PER BOX E7009AG STRL, DRAPE, LARGE DOME BAG, 20 PER BOX E7009AH STRL, DRAPE, MEDIUM DOME BAG, 20 PER BOX E7009AJ STRL, DRAPE, SMALL DOME BAG, 20 PER BOX Sterile EO, Distributed by GE Medical Systems, Milwaukee, WI 53201, Manufactured by Contour Fabricators, Inc. Fenton, MI 48430. The disposable sterile product provide a sterile barrier between the imaging device and sterile surgical field.
FDA Recall
Terminated
·GE Medical Systems, LLC·Product code MMP·August 29, 2008
4.5MM HEALIX ADVANCE¿ BR ANCHOR WITH DYNACORD¿ SUTURE (BLU,WHT/BLU/GRN,WHT/BLK)
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code MAI·July 6, 2023
5.5MM HEALIX ADVANCE¿ BR ANCHOR WITH DYNACORD¿ SUTURE (BLU,WHT/BLU/GRN,WHT/BLK)
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SÃ RL·Product code MAI·July 26, 2023
4.5MM HEALIX ADVANCE¿ BR ANCHOR WITH DYNACORD¿ SUTURE (BLU,WHT/BLU/GRN,WHT/BLK)
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code MAI·June 29, 2023
5.5MM HEALIX ADVANCE¿ BR ANCHOR WITH DYNACORD¿ SUTURE (BLE, WHI/BLU/GRN, WH/BLK)
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code MAI·March 1, 2023
4.5MM HEALIX ADVANCE¿ BR ANCHOR WITH DYNACORD¿ SUTURE (BLU,WHT/BLU/GRN,WHT/BLK)
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SÃ RL·Product code MAI·July 26, 2023
5.5MM HEALIX ADVANCE¿ PEEK ANCHOR WITH DYNACORD¿ SUT (BLU,WHT/BLU/GRN,WHT/BLK)
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code MBI·April 11, 2023
5.5MM HEALIX ADVANCE¿ PEEK ANCHOR WITH DYNACORD¿ SUT (BLU, WHT/BLU/GRN, WHT/BLK)
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code MBI·December 27, 2022