3 results
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8ms
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Sources: EU EUDAMED, US FDA
Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) ARROWgard Blue(R) Catheter Product Usage: The multiple-lumen catheter permits venous access to central circulation.
FDA Enforcement
Class I
·Terminated·Arrow International Inc·July 4, 2012
Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #: Tl0600 ~ MMP3100CHA04 T10491 MIMP3100CHA04 T12230 M2M1P3100CHA04 T15752 ~MMP3100CHA04 T15949 ~MMP3100CHA04 T17238 MMP3100CHA04 T9954 MMP3100CHA04 T9955 MMP3100CHA04 T8468 MMP3100CHA04 T11506 MMP3100CHA13 T10281 MMP3100CHA04 T8044 ~MMP3100CHA04 T17203 87-4 20-00980 T8177 ~ MMP3100CHA04 T16934 MMP3100CHA62 Tll340 SHP9109.00010 T8043 ~ MMP3100CHA04 T17321 MMPP3100CHA04 T15311 GG920010029 T1 7650 255000110 T8143 803-t 1-103 Tl4384 EK-00200690 T1666t XEB227242 T9316 MIMP3100CHA04 Tl3642 500325 T10753 ~MMP3100CH04 T9348 ~ MMP3100CHA04 T13480 MMP3100CHA042 T10243 ~MIMP3001CHA08 Tll209 ~ MMP300CHA12 Tl0861 MMP3100CHA04 T16427 MMP3100CHA04 T9894 :-. MMP3100CHA04 T12861 MMP3100CHA\041 T8088 2002CUPI T1661 1 T16611 Standard Offset Cup Impactors are handheld, reusable surgical instruments used to position and seat acetabular cups into the reamed acetabulum during hip joint replacement surgery. They are equipped with a suitable connection system to the acetabular cup (e.g. a thread) and can be supplied with a fixed or removable shock absorber. A hammer is used to deliver the necessary impact to an anvil (or impactor disc) at the rear end of the instrument.
FDA Enforcement
Class I
·Terminated·Greatbatch Medical·December 7, 2016
Medline Kits, trays, and packs labeled as follows: a) 709E RECOVERY PACK A,B,C II SS, REF DYNJ55960G; b) ABDOMEN PACK, REF DYNJ53643C; c) BAG TRUNK STOCK KIT, REF DYKM1880; d) BEDSIDE BRONCH PACK, REF DYKE1601; e) BIOPSY TRAY, REF DYNDH1242; f) BRONCH KIT, REF DYKE1840; g) BRONCHOSCOPY PACK, REF DYNJ37775F; h) BRONCHOSCOPY TRAY, REF DYNDL1350A; i) BRONCHOSCOPY TRAY, REF DYNDL1350AH; j) CAP CHANGE LARGE KIT, REF DYNDA2277A; k) CAP CHANGE LARGE KIT, REF DYNDA2277B; l) DAILY VAD DRIVELINE KIT, REF DYNDC3006; m) DAILY VENT KIT, REF DYNDJ1076; n) DIALYSIS OFF KIT, REF DT21230A; o) DIALYSIS OFF KIT, REF DT20350B; p) DIALYSIS ON KIT, REF DT20355B; q) DOUBLE HUB/CAP CHANGE KIT, REF DYNDC2843; r) DR D CUSTOM PACK, REF DYNJ68068A; s) DR D CUSTOM PACK, REF DYNJ68068B; t) DUODENUM CULTURING PACK, REF DYNJ51294; u) EGD SOUTHEASTERN REG KIT, REF DYKE1830; v) EMERGENCY UMBILICAL INSERTION, REF UVT1165; w) ENDO KIT, REF DYKE1069B; x) ENDO KIT, REF DYKE1475B; y) ERCP ENDO KIT, REF P604360B; z) ERCP SOUTHEASTERN REG KIT, REF DYKM2127; aa) FACIAL PLASTY PACK, REF DYNJ55335D; bb) FIRST YEAR KIT LF, REF EDUC1037; cc) FOLEY BULB INDUCTION KIT, REF MNS13545; dd) G BUNDLE CDS, REF CDS982759; ee) GBMC ULTRASOUND GUIDED PIV KIT, REF DYNDV2330B; ff) GBMC ULTRASOUND GUIDED PIV KIT, REF DYNDV2330C; gg) GENERAL/HERNIA PACK, REF DYNJ38541B; hh) GI BRONCHOSCOPY KIT, REF DYKE1254C; ii) HH CAR STOCK IN BIN, REF DYKM1883; jj) IMMERSION 4, REF EDUC05059A; kk) KIT LINE INSERTION, REF CVI4730; ll) KIT, PEG, SOUTHEASTERN REG, REF DYKM2128; mm) LINE INSERT PACK, REF PHS422216004C; nn) MANUAL BLADDER IRRIGATION KIT, REF UROT1051; oo) MANUAL BLADDER IRRIGATION KIT1, REF UROT1051A; pp) MANUAL BLADDER IRRIGATION KIT1, REF UROT1051AH; qq) MOHS KIT, REF DYNDA2072A; rr) MULTI LUMEN CAP CHANGE, REF DYNDA2390A; ss) N HOME CARE WOUND KIT, REF DYK1188079W; tt) NURSE KIT NO LOGO-LF, REF EDUC05036; uu) NURSE TOTE, REF DYKM1872A; vv) NURSING SKILLS, REF EDUC05015A; ww) PICC, REF CDS980470D; xx) PRE OP KIT, REF DYKS1262A; yy) PULMONARY SETUP KIT, REF DYNDA2648; zz) PULMONARY SETUP KIT, REF DYNDA2648H; aaa) REDDY JOINT BATH, REF MMJB001; bbb) REDDY JOINT BATH, REF MMJB001A; ccc) RNSG 1441, REF EDUC1029; ddd) RNSG 1441, REF EDUC1029H; eee) RNSG 2201, REF EDUC1034; fff) RNSG 2201, REF EDUC1034H; ggg) SENSITIVE SKIN WEEKLY VAD, REF DYNDC3185; hhh) SHEATH REMOVAL TRAY, REF DYNDC1311C; iii) SHORT TERM KIT, REF DYNDC3092; jjj) SINGLE HUB/CAP CHANGE KIT, REF DYNDC2841; kkk) STERILE CAP CHANGE, REF DYNDA2387A; lll) STERILE PREP KIT, REF DYNDA1359; mmm) STERILE PREP KIT, REF DYNDA1359A; nnn) STRL EK SINGLE PACK, REF DYNDA1360B; ooo) SUB PORT ACCESS TRAY, REF DYNDC2768A; ppp) SUPRA PUBIC IRRIGATION TRAY ST, REF DYNDT1019; qqq) SURGICAL PREP KIT, REF DYNJ46340B; rrr) SUTURE KIT, REF M101494; sss) SUTURE TRAY, REF DYNDS1085A; ttt) TRUNK KIT, REF DYKTRUNK1; uuu) TRUNK KIT 1EA, REF DYKM2013; vvv) UMBILICAL VESSEL INSERTION, REF DYNDA3011; www) URINALYSIS KIT, REF DYKM1251; xxx) VAD ACCESS CHANGE KIT, REF DYNDC2882B; yyy) VAD DRESSING KIT A, REF DYNDA2164; zzz) CENTRAL BLOOD CULTURE KIT, REF DYNDH1342B; aaaa) CVC DRESSING CHANGE KIT, REF EBSI1552; bbbb) PORT ACCESS POWER LOC KIT, REF DYNDC1712B; cccc) PORT ACCESS TRAY, REF DYNDC1128B;
FDA Enforcement
Class I
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·March 6, 2024