7 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Bivona brand TTS Adjustable Neck Flange Hyperflex Tracheostomy Tubes, sterile, Product 67HA70.
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code BTO·July 25, 2005
Endotec Prothesis Ankle, Titanium Alloy, Sterilized, BP Ankle System. BP Ankle System, B-P Type II Talar Ankle Component: Size 1 B-P Type II Talar Ankle Component Catalog: 05-01-0101, Size 2 B-P Type II Talar Ankle Component Catalog: 05-01-0102, Size 3 B-P Type II Talar Ankle Component Catalog: 05-01-0103, Size 4 B-P Type II Talar Ankle Component Catalog: 05-01-0104, Size 5 B-P Type II Talar Ankle Component Catalog: 05-01-0105, Size 6 B-P Type II Talar Ankle Component Catalog: 05-01-0106. BP Ankle System, BP Type II Ankle Bearing: 3x5mm BP Type II Ankle Bearing Catalog: 05-02-0103, 3x6mm BP Type II Ankle Bearing Catalog: 05-02-0113, 3x7mm BP Type II Ankle Bearing Catalog: 05-02-0123, 3x9mm BP Type II Ankle Bearing Catalog: 05-02-0143, 3x11mm BP Type II Ankle Bearing Catalog: 05-02-0163, 3x13mm BP Type II Ankle Bearing Catalog: 05-02-0183, 4x5mm BP Type II Ankle Bearing Catalog: 05-02-0104, 4x6mm BP Type II Ankle Bearing Catalog: 05-02-0114, 4x7mm BP Type II Ankle Bearing Catalog:05-02-0124, 5x5mm BP Type II Ankle Bearing Catalog: 05-02-0105, 5x7mm BP Type II Ankle Bearing Catalog: 05-02-0125, 5x9mm BP Type II Ankle Bearing Catalog: 05-02-0145. 5x6mm BP Type II Ankle Bearing Catalog 05-02-0106. 6x5mm BP Type II Ankle Bearing Catalog 05-02-0115. 6x6mm BP Type II Ankle Bearing Catalog 05-02-0116. 7x6mm BP Type II Ankle Bearing Catalog 05-02-0126. 9x6mm BP Type II Ankle Bearing Catalog 05-02-0146. 11x5mm BP Type II Ankle Bearing Catalog 05-02-0165. 11x6mm BP Type II Ankle Bearing Catalog 05-02-0166. 13x5mm BP Type II Ankle Bearing Catalog 05-02-0185. 13x6mm BP Type II Ankle Bearing Catalog 05-02-0186. BP Ankle System, B-P Type II Tibial Ankle Component Size 1 B-P Type II Tibial ankle Component Catalog: 05-03-0101, Size 2 B-P Type II Tibial ankle Component Catalog: 05-03-0102, Size 3 B-P Type II Tibial ankle Component Catalog: 05-03-0103, Size 4 B-P Type II Tibial ankle Component Catalog: 05-03-0104, Size 5 B-P Type II Tibial ankle Component Catalog: 05-03-0105, Size 6 B-P Type II Tibial ankle Component Catalog: 05-03-0106.
FDA Recall
Terminated
·Endotec, Inc.·Product code JWH·June 5, 2009
GE Healthcare MRI Systems, Software Version 12.x, sold under the following product names: SIGNA MR/I ECHOSPD W/ EXCITE, 1.5 HISPEED HD 8-CH 400-AP, MR GOLDSEAL 1.5T HD 8CH USED, UPGRADE 1.5 EXC-II TO EXC-III HD, SIGNA MR/I HISPD W/ EXCITE, 1.5 ECHOSPEED HD 16-CH 800-AP, 1.5 HISPEED HD 4-CH 200-AP, 1.5 TWINSPEED HD 8CH-400-AP, MR UPGRADE LX/HZ TO HD FOR NON LCC, 1.5 TWINSPEED HD 16CH-800-AP, 1-5T HDXT TWINSPEED 16 CHANNEL, SIGNA MR/I TWISP TR W/EXCITE, 3T HD 16CH-800-AP, 1.5 ECHOSPEED HD 4-CH 200-AP, UPGRADE PREEXCITE TO 1.5TS HD 8CH, MR GOLDSEAL 1.5T HDXT 16CH NEW, MR GOLDSEAL 1.5T HD ES 8CH MOB, 1-5T NON LCC LX/5_5 TO HDIUPG8CH, UPGRADE 1.5 EXC-II TO EXC-III 16HD, UPGRADE 1.5 HORIZON TO HS/ES EXCITE, UPGRADE FROM 1.5 4X TO HISPEED LX, 1.5 LX TO HD 8CH FORKLIFT UPG., MR GOLDSEAL 1.5 LX HISP PL NEW, MR UPGRADE 4X/5X TO HD FOR NON LCC, MR GOLDSEAL 1.5 ES+ LX, SIGNA HISPEED LX 1.5T FIXED, 3T HD T/R W/EXCITE, 1.5 ECHOSPEED HD 8-CH 400-A, SIGNA 1.5 ECHOSPEED HD 8-CH 400-A, SIGNA EXCITE HD 1.5T, MR EXCITE12X, MR GOLDSEAL 1.5T HD 8CH USE, 1.5T BRM ES 16CH 2 VRE FIXED F, UPG 1.5 EXC-II TO EXC-III HD, EXCITE HD - UPG 3.5 EXC, 1.5 ECHOSPEED HD 4-CH 200, SIGNA HD ADVANCED, EXCITE HD, 1.5 ECHOSPEED HD 16-CH, MR 1.5T HD, 1.5 ECHOSPEED HD 8-CH, MR 1.5 EXCITE HD, MR GOLDSEAL 1.5T HD ES 8CH NEW, 1.5T EXCITE HD, SIGNA ECHOSPD LX K4 1.5T FIXED, 1.5T LX TO 8CH HD 23 UPG, 1.5 HISPEED HD 8-C, SIGNA EXCITE 1.5T HD, MR 1.5T HD ECHOSPEED WITH EXCITE, MR 1.5T HD TWINSPE, MR 1.5T HD ECHOSPEED, MR SIGNA VH/I 3.0T, MR 3.0T HD 16CH, MR 1.5T HD TWINSPEED, MR 3.0T HD 8CH, MR UPG TO 1.5 HD, MR UPG TO 1.5T HD, MR UPG 1.5ES HD 8CH, SIGNA EXCITE HD 1.5 T, SIGNA EXCITE HD, SIGNA MR/I ECHOSPD 1.5T FIX(+75798), SIGNA ES EXCITE, SIGNA 1.5T ECHO HD, MR HD (VON FA. LINK), SIGNA 1.5T ECHOSPEED HD, SIGNA MR 1.5T ECHO HD, SIGNA EXITE-III HD, SIGNA 1.5T HD, ECHOSPEED HD 8-CH, 1.5 ECHOSPEED HD 8CH, MR 1.5T EXCITE HD, MR SIGNA EXCITE 3T HD, MR 1.5 ECHOSPEED HD 8-CH 400-AP, 1.5 ECHOSPEED HD, 1.5T HD, 1.5T HD PREOWN, 1.5T ECHO SPEED, 1.5 ECHOSPEED HD , SIGNA MR 1.5 ECHOSPEED 8CH, SIGNA HD 1.5 ES, MR ECHOSPEED 1.5 HD, SIGNA 1.5TECHOSPEED, MR 1.5 ECHOSPEED HD 8-CH, 1.5T HD EXCITE, SIGNA 1.5 T ECHOSPEED, SIGNA VH/I 3.0T, MR 1.5T HD 16CH, MR 1.5T HD 8CH USED, SIGNA EXCITE3 HD, MR SIGNA EXCITE HD (UPGR.), 1.5T EXCITE-HD, 1.5T EX-HD TWIN, SIGNA 3T, MR 1.5 ECHOSPEED HD 8-CH 400-A, 1.5T EXCITE HD GS, 3T E2, 1.5 ECHOSPEED HD 8-CH 400-, SIGNA EXCITE III HD 1.5T TWIN SPEED, MR GOLDSEAL 1.5T HD 16CH USED, EXCITE II UPG, SIGNA EXCITE III HD 3.0T, MR SIGNA EXCITE, 1.5T SIGNA EXCITE III HD, MR SIGNA HD, SIGNA EXCITE HD 1.5, 3T EXCITE HD, UPG PREEXCITE TO 1.5ES HD 8CH, MR SIGNA SMARTSPEED 1.5, 1.5T HD ECHOSPEED 8 CHANNEL, SIGNA 1.5 MOBILE EXCITE HD, SIGNA 3T HD 16CH-800-AP, SIGNA 3T HD 8CH-400-AP, 1.5T MRI EXCITE 3 UPGRADE, MR 1.5 ECHOSPEED HD 4-CH 200-AP, SIGNA 1.5 ECHOSPEED HD 8-CH 400-AP, SIGNA EXCITE 1.5T ECHOSPEED HD 4CH, MR 3T HD 8CH-400-AP, SIGNA 1.5T ECHOSPEED HD 4-CH 200-AP, 1.5 ECHOSPEED HD 16CH 800AP-2669585, 1.5 ECHOSPEED HD 8-CH 400-AP2669575, 1.5T ECHOSPEED HD16-CH800-AP2669583, UPG 1.5 EXC-II TO EXC-III HD-561936, 1.5 TWINSPEED HD 8CH-400-AP-2583394, 1.5 ECHOSPEED HD 8-CH 400-AP2700482, 1.5 ECHOSPEED HDMR, 1.5 ECHOSPEED HD 8-CH 400-AP EXCITE, MR 1.5 ECHOSPEED HD 8-C, MR SIGNA 1.5T HD 8CH, MR SIGNA 15T HD UPGRADED, MR SIGNA 3T HD 8CH-400-AP, MR SIGNA 1.5T HD UPGRADED, MR SIGNA 1.5T HD 8CH MOBIL, EXCITE HD 1.5T UPGRADES, MR SIGNA EXCITE HD 15T, MR SIGNA EXCITE HD 1.5T, MR 1.5 ECHOSPEED HD 16-CH, MR PROFILE HD PHASE ARRAY, SIGNA 3T EX HD, MR SIGNA VH/I 3.0, MR SIGNA MR/I HISPEED 1.5T, 1.5T ECHOSPEED HD, 1.5 ECHOSPEED HD 8, 1.5T ECHOSPEED HD 8, 1.5 T ECHOSPEED HD 4-CH 200-AP, SIGNA EXCITE 3T HD 8CH-400-AP, MR 1.5T ECHOSPEED HD 8-CH 400-AP, MR 1.5 ECHOSPEED HD 4-CH 200-A, MR/I 1.5 ECHOSPEED HD 4CH 200-, MR 15T ECHOSPEED HD 8-CH 400-, MR 15 ECHOSPEED HD 4-CH 200-A, MR 1.5 ECHOSPEED HD 8-CH 400-AP//, SIGNA 1.5T, SIGNA MR/I ECHOSPD W/ EXCIT, 1.5T EXCITE HD 16 CH, 1.5T HD E
FDA Enforcement
Class II
·Terminated·GE Medical Systems, LLC·October 24, 2018
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013