17 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
POWERPORT DUO M.R.I. IMPLANTED PORT WITH 9.5 FR. DUAL LUMEN CHRONOFLEX POLYURETHANE CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526827844·***DISC*LEVAMED ANKLE SUPPORT BLACK II
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526827905·ACHIMED ACHILLES SUPP BLACK II
LEONE SPA
FDA UDI
LEONE SPA·08033707065678·INTRAORAL ELASTICS 2,5 oz 3/8" orange
OSCILLOMITT, MODELS CM 1050, CM 1040, CM 1030, CM 1020, CM 1010
FDA 510(k)
FDA Class 2
·Cardiovascular
MTI ST#1 SILICONE PESSARY
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 17, 2024
BE-VKMO 70000 #QUADR-I HMO70000+VHK7100
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015
BE-VKMO 70000 #QUAD-I HMO70000+VHK7100
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015
BE-VKMO 70000 #QUADR-I HMO70000+VHK7100
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015
BE-VEMO 7000 #QUADR-I HMO70000+VHK7100
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015
TENDRIL ST
FDA Adverse Event
Death
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·May 2, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·September 15, 2014
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·April 19, 2011
Sierra Pre-Filled, Normal Saline IV Flush, Catalog #0905-12, NDC #64054-0905-2, 5 mL Fill in a 12mL Syringe, 0.9% Sodium Chloride Injection USP, 120/Case, For Single Use Only, Rx only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501
FDA Recall
Terminated
·AM2 PAT INC·Product code FOZ·December 11, 2007
SAGB QuickClose Swedish Adjustable Gastric Band including Velocity" Injection Port and Applier. Product Code BD2XV, Lot #: 1040602, , 1040603, , 10270503, , 11020504, , 11030502, , 11090510, , 11090511, 1090512, 12030502, 12070502, 12070503, 12070504, 12200501, 12200502, 12200503, 12290505, 12290506, 01120603, 01200602, 01260601, 01260602, 01260603, 01260604, 02210605, 02210606, 02210607, 02280622, 02280623, 03080601, 03080602, 03080605, 03220611, 03220612, 05150601, 05150602, 05150603, 05150604, 05300613, 05300614, 06190606, 06190607, 06190608, 06190614, 06190615, 06190616, 06190617, 06190618, 06260601, 07060601, 07100605, 08140607, 08140608, 09050601, 09050602, 09050603, 09050604, 09050605, 09130601, 09130602, 09130603, 09130604, 09130605, 09180602, 09180603, 09180604, 09250602, 10110601, 10110602, 10110603, 20002024, 20002082, 20002185, 20002186, 20002193, 20002438, 20002439, 20002440, 20002441, 20002484, 20002485, 20003152, 20003153, 20003154, 20003155, 20003196, 20003362, 20003363, 20004437, 20004438, 20005244, 20005659, 20006819, 20006921, ZGNB43, ZGNB44, ZGNB45, ZGPBCC, ZGPBCD, ZGPBCJ, ZGPBCK, ZHBBBN, ZHBBBP, ZHBBBT, ZHCBB0, ZHCBB1, ZHCBB2, ZHCBB3, ZHCBB5, ZHCBB6, ZHCBB7, ZHCBB8, ZHCBB9, ZHDBF7, ZHFB76, ZHFB77, ZHFB79, ZHFBBW, ZHFBBY, ZHGBBJ, ZHGBDJ, ZHGBDK, ZHGBDL, ZHHBD6, ZHHBD7, ZHHBD8, ZHHBD9, ZHHBFB, ZHHBFC, ZHJBBJ, ZHJBBK, ZHJBBL, ZHJBBM, ZHJBBN, ZHJBBP, ZHMBDP, ZHNBC1, ZHNBC2, ZHPBBT, ZJBBBF, ZJBBDP, ZJCBB6, ZJCBDP, ZJCBGL, ZJDBBD, ZJDBBF, ZJDBBG, ZJDBBH, ZJDBBJ, ZJDBBK, ZJFBL6, ZJFBML, ZJHBCH, ZJHBK7, ZJJBC3, ZJKBC1, ZJKBHC, ZJKBK2, ZJMBB4, ZJMBN9, ZJNBBV, ZKDBM6, ZKDBM7, ZKFBDC, ZKFBDH, ZKGBDY, ZKHBBJ, ZKHBCR, ZKHBFG, ZKNBCK, ZKNBHC, ZLBBFK, ZLDBB8, ZLFBBC, ZLFBGG, ZLGBFV & ZLGBG5.
FDA Recall
Terminated
·Ethicon Endo-Surgery Inc·Product code LTI·September 27, 2010
Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024