54 results
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19ms
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Sources: EU EUDAMED, US FDA
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Evolut (TM) R System. With the following model numbers: a. EVOLUTR-23, Labeled as VLV EVOLUTR-23 VT IR 6L COMM OUS, VLV EVOLUTR-23 TAV EVOLUT R CE 29L MX, VLV EVOLUTR-23 TAV CE AU 2Y MX, VLV EVOLUTR-23 TAV JPN MX, VLV EVOLUTR-23 GREY 29L COMM OUS, VLV EVOLUTR-23 TAV EVOLUT R CE 7L MX, VLV EVOLUTR-23 TAV EVOLUT R CE 26L MX, VLV EVOLUTR-23 TAV CA 2Y MX, VLV EVOLUTR-23 GREY 6L COMM OUS, VLV EVOLUTR-23-US TAV 23 US COMM MX; b. EVOLUTR-23-C, Labeled as VLV EVOLUTR-23-C TAV EVOLUT R US IDE MEX; c. EVOLUTR-23-US, Labeled as VLV EVOLUTR-23-US GREY COMM US, VLV EVOLUTR-23-US TAV 23 US COMM MX; d. EVOLUTR-26, Labeled as VLV EVOLUTR-26 TAV EVOLUT R CE 29L MX VLV EVOLUTR-26 VT IR 6L COMM OUS, VLV EVOLUTR-26 TAV EVOLUT R CE 7L MX, LV EVOLUTR-26 TAV CE AU 2Y MX, VLV EVOLUTR-26 TAV JPN MX, VLV EVOLUTR-26 GREY 29L COMM OUS, VLV EVOLUTR-26-US TAV 26 US COMM MX, VLV EVOLUTR-26 TAV CLN OUS MX, VLV EVOLUTR-26 TAV CA 2Y MX, VLV EVOLUTR-26 TAV CE CA 2Y MX, VLV EVOLUTR-26 GREY 6L COMM OUS; e. EVOLUTR-26-C, Labeled as VLV EVOLUTR-26-C TAV EVOLUT R US IDE MEX, VLV EVOLUTR-26-C TAV CLN US MX; f. EVOLUTR-26-US, Labeled as VLV EVOLUTR-26 TAV EVOLUT R CE 29L MX, VLV EVOLUTR-26-US GREY COMM US, VLV EVOLUTR-26-US TAV 26 US COMM MX; g. EVOLUTR-29, Labeled as VLV EVOLUTR-29 TAV EVOLUT R CE 29L MX, VLV EVOLUTR-29 GREY 6L COMM OUS, VLV EVOLUTR-29 VT IR 6L COMM OUS, VLV EVOLUTR-29 TAV CE AU 2Y MX, VLV EVOLUTR-29 TAV JPN MX, VLV EVOLUTR-29 GREY 29L COMM OUS, VLV EVOLUTR-29 TAV EVOLUT R CE 7L MX, VLV EVOLUTR-29 TAV CLN OUS MX, VLV EVOLUTR-29 TAV CA 2Y MX, VLV EVOLUTR-29 TAV CE CA 2Y MX, VLV EVOLUTR-29-US TAV 29 US COMM MX; h. EVOLUTR-29-C, Labeled as VLV EVOLUTR-29-C TAV EVOLUT R US IDE MEX, LV EVOLUTR-29-C TAV CLN US MX, VLV EVOLUTR-29-US TAV 29 US COMM MX; i. EVOLUTR-29-US, Labeled as VLV EVOLUTR-29-US GREY COMM US, VLV EVOLUTR-29-US TAV 29 US COMM MX, VLV EVOLUTR-29 TAV EVOLUT R CE 29L MX; j. EVOLUTR-34, Labeled as VLV EVOLUTR-34 BLUE 29L COMM OUS, VLV EVOLUTR-34 VT IR 6L COMM OUS, VLV EVOLUTR-34 BLUE 6L COMM OUS, VLV EVOLUTR-34 TAV CE AU 2Y MX, VLV EVOLUTR-34 TAV JPN MX, VLV EVOLUTR-34 TAV CLN OUS MX, VLV EVOLUTR-34 TAV CA 2Y MX, VLV EVOLUTR-34 TAV CE CA 2Y MX, VLV EVOLUTR-34 TAV EVOLUT R CE 29L 1Y MX, VLV EVOLUTR-34 TAV EVO R CE 29L 2Y MX SA, DRAPE 9732722 TUBE STERILE O-ARM 20PK; k. EVOLUTR-34-C, Labeled as VLV EVOLUTR-34-C TAV EVOLUT R US IDE MX, VLV EVOLUTR-34-C TAV CLN US MX; l. EVOLUTR-34-US, Labeled as VLV EVOLUTR-34-US BLUE COMM US, VLV EVOLUTR-34-US TAV 34 US COMM MX, VLV EVOLUTR-34 TAV EVOLUT R CE 29L 1Y MX, VLV EVOLUTR-34-US TAV 34 US COMM MX SA.
FDA Recall
Terminated
·Medtronic Heart Valves Division·Product code NPT·October 23, 2020
GYRUS ACMI, dissector PlasmaKnife" , REF 7035-3005, Rx only, STERILE R, CE 0344, 161416-CA, MANUFACTURED FOR; GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01722-2104, USA, EC REP, GYRUS MEDICAL LIMITED, FORTRAN ROAD, ST. MELLONS, CARDIFF, CF3 0LT, UK
FDA Recall
Terminated
·Gyrus Acmi, Incorporated·Product code GEI·August 6, 2010
NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619
FDA Recall
Terminated
·Nobel Biocare Usa Llc·Product code NHA·July 19, 2019
Epix latis GRASPER, 5mm x 45 cm, REF: C4140, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110154
FDA Recall
Terminated
·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code NWV·March 17, 2020
Epix latis GRASPER, 5 mm x 35 cm, REF C4130, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110147
FDA Recall
Terminated
·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code NWV·March 17, 2020
UroLift System REF Catalog Number: UL400-4 Tray Contents: UroLift System with Handle Release Tool STERILE R CE 0050 Manufactured By: neotract
FDA Recall
Terminated
·Neotract Inc·Product code PEW·July 6, 2018
CERCLAGE WIRE, 0.6 MM DIA. X 175 MM LENGTH, SST, REF 71163006, QTY: (6), STERILE R, CE 008, 2020/07, Smith & Nephew, Inc., Memphis, TN 38116, EC REP: Smith & Nephew Orthopaedics GmbH, Tuttlingen, Germany Usage: Bone fracture fixation
FDA Recall
Terminated
·Smith & Nephew Inc·Product code JDQ·June 28, 2010
CERCLAGE WIRE, 0.8 MM DIA. X 200 MM LENGTH, SST, REF 71163008, QTY: (6), STERILE R, CE 008, 2020/07, Smith & Nephew, Inc., Memphis, TN 38116, EC REP: Smith & Nephew Orthopaedics GmbH, Tuttlingen, Germany Usage: Bone fracture fixation
FDA Recall
Terminated
·Smith & Nephew Inc·Product code JDQ·June 28, 2010
ENCORE (R) Microptic (R) Powder-Free Latex Surgical Gloves, 1 Pair, Size 5, Sterile R, CE 0086, EC REP Ansell (UK) Ltd., Tamworth, Staffordshire, B79 7UL UK, Ansell Lanka (pvt) Ltd., Biyagama Export Processing Zone, Biyagama, Sri Lanka Intended use: Surgical Gloves
FDA Recall
Terminated
·Ansell Healthcare Products LLC·Product code KGO·September 3, 2010
PERI-LOC (R), 3.5 MM ANTEROLATERAL DISTAL TIBIA PLATE, 10 HOLE, RIGHT - 148 MM, REF 71800710, QTY: (1), STERILE R, CE 0086, Smith & Nephew, Inc., Memphis, TN 38116, USA, EC REP: Smith & Nephew Orthopaedics Gmbh, Tuttlingen, Germany. Adult and pediatric patients, as indicated for pelvic, small, and long bone fracture fixation.
FDA Recall
Terminated
·Smith & Nephew Inc·Product code HRS·July 20, 2010
Ami HTX.
FDA Recall
Open, Classified
·Spectral Instruments Inc·Product code RCE·May 13, 2025
Nikon Metrology XTH cabinet x-ray Systems which includes variations STH225, XTH225ST, and MCT225.
FDA Recall
Terminated
·Nikon Metrology·Product code RCE·December 23, 2019
v|tome|x L Series non-destructive testing cabinet x-ray systems
FDA Recall
Terminated
·Ge Inspection Technologies Llc·Product code RCE·September 29, 2020
YXLON Cougar Cabinet X-Ray System Product Usage: The products are generally used for non-destructive testing and quality control
FDA Recall
Terminated
·Comet Technologies Usa Inc·Product code RCE·October 1, 2018
GE Inspection Technologies x|tome|x L240 an Cabinet X-ray system
FDA Recall
Terminated
·Product code RCE·January 13, 2015
GE eXplore Locus Micro CT cabinet x-ray system model RS9-80. CT Scanner for laboratory mice or other research.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code RCE·January 31, 2011
Phoenix x/ray analyser series. Phoenix x|ray analyser series cabinet x-ray systems are used in non-destructive testing, failure analysis, process control, and metrology.
FDA Recall
Terminated
·Product code RCE·March 16, 2009
Lago X
FDA Recall
Open, Classified
·Spectral Instruments Inc·Product code RCE·May 13, 2025
GE Inspection Technologies Blade|line Industrial Cabinet X-ray system
FDA Recall
Terminated
·Product code RCE·June 28, 2017
PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Programmer software. Software approved for use with BIOTRONIK device programmers (trade names: Renamic and ICS 3000). Allows physicians to program devices to pace exclusively in the left ventricle.
FDA Recall
Terminated
·BIOTRONIK, Inc.·Product code rce·June 30, 2015