10,000 results
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28ms
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Sources: EU EUDAMED, US FDA
ExacTrac 6.0.x Patient Positioning System, Radiation therapy. Intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures.
FDA Enforcement
Class II
·Terminated·Brainlab AG·September 2, 2015
ExacTrac versions 6.5 through 6.5 intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. ExacTrac may also be used to monitor the patient position during the treatment.
FDA Enforcement
Class II
·Terminated·Brainlab AG·March 21, 2018
ExacTrac 6.0 is a patient positioning and monitoring system. Model/catalogue numbers: 20833B EXACTRAC 6.0 IR POSITIONING SOFTWARE 49936 ET SOFTWARE UPDATE 6.0.X TO 6.0.3 49926B ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR) 49934A EXACTRAC UPGRADE 5.5 TO 6.0 BASIC 49927B ET UPGRADE SOFTWARE 4.X TO 6.0 (IR+XR) 49928B ET UPGRADE SOFTWARE 5.X TO 6.0 (IR+XR) 49933B ET UPGRADE TRUEBEAM 5.5 TO 6.0 LIMITED 49973B ET DATA PREP / REVIEW SYSTEM 49998B ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT 49996B ET UPGRADE SOFTWARE X.X TO 6.0 SW ONLY 49997B ET UPGRADE SOFTWARE 5.5 TO 6.0 LIMITED
FDA Enforcement
Class II
·Terminated·Brainlab AG·May 7, 2014
ExacTrac is intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. ExacTrac may also be used to monitor the patient position during the treatment.
FDA Enforcement
Class II
·Terminated·Brainlab AG·August 13, 2014
Quickie IRIS Wheelchair. model EIZ4-2 in combination with option code 183M02 - MONO Backrest system with Dynamic Backrest option. Provide mobility to persons limited to a sitting position.
FDA Enforcement
Class II
·Terminated·Sunrise Medical (US) LLC·September 2, 2015
STAR S4 IR Excimer System (STAR S4 IR) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations.
FDA Enforcement
Class II
·Terminated·Abbott Medical Optics, Inc.·June 19, 2013
Animas(R) 2020, Animas(R) IR 1250 (1200 plus), Animas(R) IR 1200 Insulin Infusion Pumps Indicated for continuous subcutaneous infusion of insulin.
FDA Enforcement
Class III
·Terminated·Animas Corporation·February 27, 2013
IR1200, IR1250(IR1200 Plus), 2020 and One Touch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver insulin therapy.
FDA Enforcement
Class II
·Terminated·Animas Corporation·October 10, 2012
4FR Single Lumen Pressure Injectable PICC; intravascular therapeutic catheter, for long-term use greater than 30 days.
FDA Enforcement
Class II
·Terminated·Arrow International Inc·October 21, 2015
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
XCELA PASV 5F SL 55CM IR-145 Nitinol Wire KIT PG, Catalog Number 25-124
FDA Enforcement
Class II
·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·June 20, 2018
Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved PG, Catalog Number 45-872
FDA Enforcement
Class II
·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·June 20, 2018
Bio-Stable 5F SL-55CM IR-145 Kit Valved PG, Catalog Number 45-818
FDA Enforcement
Class II
·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·June 20, 2018
Bio-Stable 5F SL-55CM IR-145 Kit Valved with Nitinol GW PG, Catalog Number 45-882
FDA Enforcement
Class II
·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·June 20, 2018
Centurion-_General Surgery Trays DYNDA1127A RADIOLOGY CUT DOWN TRAY #1 DYNDA1178 ICIO TRAY DYNDA1183 AUXILARY TOWEL PACK DYNDA1223 CUSTOM PREP CUP KIT DYNDA1223 CUSTOM PREP CUP KIT DYNDA1246A CIRCUMCISION PACK DYNDA1349A CIRCUMCISION TRAY DYNDA1388 STERILE EK DOUBLE PACK DYNDA1615 STERILE BARRIER KIT DYNDA1615 STERILE BARRIER KIT DYNDA1628 VAG DELIVERY ACCESSORY PACK DYNDA1706A CIRCUMCISION TRAY W/OUT CLAMP DYNDA1843A DISPOSABLE SUTURE TRAY FGS DYNDA1843A DISPOSABLE SUTURE TRAY FGS DYNDA1861 IR KIT DYNDA1904 PREP TRAY DYNDA2076 VEIN PROCEDURE KIT DYNDA2201 SMALL BOWL KIT DYNDA2241 CIRCUMCISION TRAY DYNDA2271 CIRCUMCISION TRAY DYNDA2361 HYSTERO PACK - RADIOLOGY WEILER DYNDA2361 HYSTERO PACK - RADIOLOGY WEILER DYNDA2418 MINOR PROCEDURE TRAY DYNDA2498 STERILE UNIVERSAL KIT
FDA Enforcement
Class II
·Terminated·Centurion Medical Products Corporation·February 12, 2020
Bio-Stable 5F SL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-886
FDA Enforcement
Class II
·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·June 20, 2018
Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-887
FDA Enforcement
Class II
·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·June 20, 2018
DONJOY REF:11-0472-9 ULTRASLING PRO ER/IR 30, UNIVERSAL, Rx ONLY, UDI: (01)00190446683674 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
FDA Enforcement
Class II
·Terminated·DJ Orthopedics de Mexico S.A. de C.V.·May 5, 2021
RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. RadSuite provides a means to distribute, display, and store diagnostic-quality medical images in electronic format.
FDA Enforcement
Class II
·Terminated·Merge Healthcare, Inc.·September 7, 2016
5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with 70 cm Guidewire Unit Label: PowerPICC REF CK000340B BARD MYPICC KIT 5F French Size Dual-Lumen 70cm Guidewire
FDA Enforcement
Class II
·Terminated·Bard Access Systems Inc.·July 7, 2021