19 results
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6ms
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Sources: EU EUDAMED, US FDA
Titanium MPJ (Toe Implant)TOE JOINT TITANIUM NPC LG, Part ID 16816
FDA Enforcement
Class II
·Terminated·BioPro, Inc.·March 9, 2022
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC LG, Part ID 17038
FDA Enforcement
Class II
·Terminated·BioPro, Inc.·March 9, 2022
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MS, Part ID 17197
FDA Enforcement
Class II
·Terminated·BioPro, Inc.·March 9, 2022
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC ML, Part ID 16815
FDA Enforcement
Class II
·Terminated·BioPro, Inc.·March 9, 2022
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MD, Part ID 17036
FDA Enforcement
Class II
·Terminated·BioPro, Inc.·March 9, 2022
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813
FDA Enforcement
Class II
·Terminated·BioPro, Inc.·March 9, 2022
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MS, Part ID 17198
FDA Enforcement
Class II
·Terminated·BioPro, Inc.·March 9, 2022
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD, Part ID 16814
FDA Enforcement
Class II
·Terminated·BioPro, Inc.·March 9, 2022
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC M/L, Part ID 17037
FDA Enforcement
Class II
·Terminated·BioPro, Inc.·March 9, 2022
Titanium MPJ (Toe Implant)TOE JOINT TITANIUM PC SM, Part ID 17035
FDA Enforcement
Class II
·Terminated·BioPro, Inc.·March 9, 2022
MAJ-247 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-247 - Product Usage: REPLACEMENT BASKET for BML-3Q Mechanical Lithotripter.
FDA Enforcement
Class II
·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021
MAJ-244 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-244 - Product Usage: REPLACEMENT BASKET for BML-3Q Mechanical Lithotripter.
FDA Enforcement
Class II
·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021
Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209 Product Usage: This product has been designed to be attached to the suction cylinder of compatible endoscopes for aspirating fluid from the distal end of the endoscopes through the instrument channel. Compatible endoscopes include Olympus bronchoscopes, cystoscopes, rhino-laryngoscopes and pleurascopes models.
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·August 14, 2019
Olympus WM-NP2 or WM-DP2 Mobile Workstations with Nurse Control Panel Arm, Model. No. MAJ-1664
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·July 24, 2019
Duodenoscope and accessories, flexible/rigid - Product Usage: used with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy accessories (such as biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·March 31, 2021
MAJ-1606 Instrument Channel Adaptor; a single use adapter which enables a connection between the endoscope's instrument channel port and the O FP-2 pump's tubing.
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·October 14, 2015
EVIS EXERA Duodenovideoscope Olympus TJF Type 160F/VF used with an Olympus video system center, light source, documentation equipment monitors, Endo Therapy accessories and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·June 8, 2016
Invacare Power Wheelchair, one per box To provide mobility to a person restricted to a sitting position.
FDA Enforcement
Class II
·Terminated·Invacare Corporation·October 2, 2013
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 Enforcement
Class II
·Terminated·Medtronic Heart Valves Division·December 16, 2020