36 results
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8ms
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Sources: EU EUDAMED, US FDA
PINNACLE¿ Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM¿ Sheath PINNACLE¿ TIF TIP" Introducer Sheath PINNACLE¿ R/O II Radiopaque Marker Introducer Sheath
FDA Enforcement
Class II
·Terminated·Terumo Medical Corporation·September 14, 2016
Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305
FDA Enforcement
Class II
·Ongoing·Fujifilm Irvine Scientific, Inc.·April 5, 2023
PharmaCaribe PulmoSal 7% Sodium chloride, Inhalation Solution, 7% Sterile, Preservative -free, Non-pyrogenic, pH 7.4 For Inhalation Only Rx Product Usage: The contents of these vials are used in conjunction with a nebulizer for the induction of sputum production where sputum production is indicated.
FDA Enforcement
Class II
·Terminated·Pharmacaribe llc·February 17, 2016
TB-0545PC: THUNDERBEAT 5 mm , 45 em, Pistol Grip TB-0535PC: THUNDERBEAT 5 mm, 35 em, Pi stol Grip TB-0545IC: THUNDERBEAT 5 mm, 45 em, In line Grip TB-0535IC: THUNDERBEAT 5 mm, 35 em, Inline Grip TB-0520IC: THUNDERBEAT 5 mm, 20 em, In line Grip TB-051 OIC: THUNDERBEAT 5 mm, I 0 em, In line Grip TB-545FC: THUNDERBEAT 5 mm, 45 em, Front Actuated Grip TB-0535FC: THUNDERBEAT 5 mm, 35 em, Front Actuated Grip The Olympus Thunderbeat Surgical Tissue Management System ("Thunderbeat") is intended to be used for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.
FDA Enforcement
Class II
·Terminated·Olympus America Inc.·December 11, 2013
Dressit-X, Radiopaque D-545, NDC 11004-545-40, Dental Use Only, Active Ingredients: Eugenol Oil
FDA Enforcement
Class II
·Terminated·Rainbow Specialty & Health Products·December 30, 2015
Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane
FDA Enforcement
Class II
·Ongoing·ACTIM OY·April 24, 2024
Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray device produces conventional 2D X-ray images and Xray projection images for the reconstruction of a 3D view. The device is operated and used by qualified healthcare professionals.
FDA Enforcement
Class II
·Ongoing·Palodex Group Oy·August 21, 2024
CARESCAPE VC150 Vital Signs Monitor; Intended to monitor a single patient's vital signs at the site of care.
FDA Enforcement
Class II
·Terminated·INNOKAS MEDICAL OY·August 31, 2016
VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique only); Innokas Medical CARESCAPE VC150 Rx Only Innokas Medical Oy. Catalog numbers 2067980-002, 2067980-006, 2067980-010, and 2067980-014.
FDA Enforcement
Class II
·Terminated·INNOKAS MEDICAL OY·February 4, 2015
CARESCAPE VC150 Vital Signs Monitor Monitor vital signs in humans
FDA Enforcement
Class II
·Terminated·Innokas Medical Oy·November 18, 2015
Soredex DIGORA Optime SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
FDA Enforcement
Class II
·Terminated·Palodex Group Oy·January 29, 2020
KaVo Scan eXam SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
FDA Enforcement
Class II
·Terminated·Palodex Group Oy·January 29, 2020
Instrumentarium Dental Express SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
FDA Enforcement
Class II
·Terminated·Palodex Group Oy·January 29, 2020
Gendex GXPS-500 SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
FDA Enforcement
Class II
·Terminated·Palodex Group Oy·January 29, 2020
CARESCAPE Canvas Smart Display, Model Numbers: a) 5514418, b) 5514418 / MAEP2, c) 5514418-01059642, d) 5514418-01080402, e) 5514418-01081317, f) 5514418-01086007, g) 5514418-01086838, h) 5514418-01088182, i) 5514418-01108442, j) 5514418-01118673, k) 5514418-01120764, l) 5514418-01166521, m) 5514418-01180241, n) 5514418-01181177, o) 5514418-01183037, p) 5514418-01184556, q) 5514418-01184557, r) 5514418-01185805, s) 5514418-01186277, t) 5514418-01187473, u) 5514418-01188453, v) 5514418-01190677, w) 5514418-01192703, x) 5514418-01192705, y) 5514418-01203242, z) 5514418-01206279, aa) 5514418-01208248, bb) 5514418-01212670, cc) 5514418-01215947, dd) 5514418-01218564, ee) 5514418-01222489, ff) 5514418-01222812, gg) 5514418-01223831, hh) ii) 5514418-01228038, ii) 5514418-01228181, jj) 5514418-01230534, kk) 5514418-01235322, ll) 5514418-01236388, mm) 5514418-01244357, nn) 5514418-01250690, oo) 5514418-01250761, pp) 5514418-01256439; monitor, physiological, patient
FDA Enforcement
Class II
·Ongoing·GE Healthcare Finland Oy·July 3, 2024
CARESCAPE B650: Model Numbers: a) MBB313, Model Numbers: 1) 2095801-001, 2) 2095801-001-01018416, 3) 2095801-001-01023150, 4) 2095801-001-01023151, 5) 2095801-001-01023152, 6) 2095801-001-01032962, 7) 2095801-001-01033915, 8) 2095801-001-01034302, 9) 2095801-001-01034399, 10) 2095801-001-01034528, 11) 2095801-001-01034573, 12) 2095801-001-01035087, 13) 2095801-001-01036384, 14) 2095801-001-01037712, 15) 2095801-001-01038022, 16) 2095801-001-01038593, 17) 2095801-001-01041035, 18) 2095801-001-01041611, 19) 2095801-001-01041694, 20) 2095801-001-01042512, 21) 2095801-001-01043771, 22) 2095801-001-01043810, 23) 2095801-001-01043815, 24) 2095801-001-01044650, 25) 2095801-001-01045256, 26) 2095801-001-01045394, 27) 2095801-001-01047045, 28) 2095801-001-01047175, 29) 2095801-001-01047424, 30) 2095801-001-01047840, 31) 2095801-001-01048362, 32) 2095801-001-01048417, 33) 2095801-001-01048980, 34) 2095801-001-01051456, 35) 2095801-001-01052158, 36) 2095801-001-01052233, 37) 2095801-001-01055544, 38) 2095801-001-01056326, 39) 2095801-001-01057436, 40) 2095801-001-01059243, 41) 2095801-001-01059748, 42) 2095801-001-01063874, 43) 2095801-001-01065225, 44) 2095801-001-01066765, 45) 2095801-001-01068762, 46) 2095801-001-01068763, 47) 2095801-001-01068789, 48) 2095801-001-01069489, 49) 2095801-001-01069499, 50) 2095801-001-01069511, 51) 2095801-001-01069736, 52) 2095801-001-01071206, 53) 2095801-001-01071246, 54) 2095801-001-01071369, 55) 2095801-001-01071456, 56) 2095801-001-01071457, 57) 2095801-001-01073465, 58) 2095801-001-01073479, 59) 2095801-001-01073480, 60) 2095801-001-01073804, 61) 2095801-001-01073821, 62) 2095801-001-01073831, 63) 2095801-001-01073833, 64) 2095801-001-01073842, 65) 2095801-001-01075357, 66) 2095801-001-01075506, 67) 2095801-001-01075588, 68) 2095801-001-01075714, 69) 2095801-001-01075924, 70) 2095801-001-01077403, 71) 2095801-001-01077441, 72) 2095801-001-01077461, 73) 2095801-001-01079833, 74) 2095801-001-01079863, 75) 2095801-001-01083142, 76) 2095801-001-01083734, 77) 2095801-001-01085418, 78) 2095801-001-01085443, 79) 2095801-001-01086276, 80) 2095801-001-01086712, 81) 2095801-001-01086761, 82) 2095801-001-01086774, 83) 2095801-001-01086812, 84) 2095801-001-01087472, 85) 2095801-001-01087477, 86) 2095801-001-01087541, 87) 2095801-001-01090666, 88) 2095801-001-01090675, 89) 2095801-001-01091331, 90) 2095801-001-01091461, 91) 2095801-001-01093653, 92) 2095801-001-01094099, 93) 2095801-001-01094103, 94) 2095801-001-01094107, 95) 2095801-001-01094246, 96) 2095801-001-01095946, 97) 2095801-001-01097590, 98) 2095801-001-01099368, 99) 2095801-001-01101966, 100) 2095801-001-01101967, 101) 2095801-001-01103899, 102) 2095801-001-01103993, 103) 2095801-001-01105509, 104) 2095801-001-01106417, 105) 2095801-001-01108128, 106) 2095801-001-01109198, 107) 2095801-001-01111183, 108) 2095801-001-01111184, 109) 2095801-001-01111601, 110) 2095801-001-01112917, 111) 2095801-001-01113476, 112) 2095801-001-01114061, 113) 2095801-001-01115803, 114) 2095801-001-01116299, 115) 2095801-001-01117382, 116) 2095801-001-01117424, 117) 2095801-001-01119791, 118) 2095801-001-01119805, 119) 2095801-001-01120649, 120) 2095801-001-01120762, 121) 2095801-001-01123351, 122) 2095801-001-01124300, 123) 2095801-001-01126694, 124) 2095801-001-01127783, 125) 2095801-001-01128064, 126) 2095801-001-01128764, 127) 2095801-001-01130112, 128) 2095801-001-01132721, 129) 2095801-001-01133150, 130) 2095801-001-01133492, 131) 2095801-001-01133517, 132) 2095801-001-01134200, 133) 2095801-001-01135675, 134) 2095801-001-01135943, 135) 2095801-001-01137569, 136) 2095801-001-01138299, 137) 2095801-001-01140050, 138) 2095801-001-01141178, 139) 2095801-001-01149187, 140) 2095801-001-01152254, 141) 2095801-001-01153436, 142) 2095801-001-01155553, 143) 2095801-001-01156974, 144) 2095801-001-01158167, 145) 2095801-001-011632
FDA Enforcement
Class II
·Ongoing·GE Healthcare Finland Oy·July 3, 2024
CARESCAPE Canvas 1000, Model Numbers: a) 5865770; b) 5865770-01040169; c) 5865770-01054142; d) 5865770-01054696; e) 5865770-01054698; f) 5865770-01054721; g) 5865770-01054740; h) 5865770-01055202; i) 5865770-01055204; j) 5865770-01055270; k) 5865770-01055317; l) 5865770-01055796; m) 5865770-01058501; n) 5865770-01058596; o) 5865770-01058597; p) 5865770-01059641; q) 5865770-01062146; r) 5865770-01065501; s) 5865770-01065702; t) 5865770-01065703; u) 5865770-01065739; v) 5865770-01065740; w) 5865770-01074051; x) 5865770-01074386; y) 5865770-01076001; z) 5865770-01077195; aa) 5865770-01077196; bb) 5865770-01079968; cc) 5865770-01080218; dd) 5865770-01080222; ee) 5865770-01080227; ff) 5865770-01080925; gg) 5865770-01080960; hh) 5865770-01081316; ii) 5865770-01081386; jj) 5865770-01083664; kk) 5865770-01085971; ll) 5865770-01086005; mm) 5865770-01086006; nn) 5865770-01086160; oo) 5865770-01086235; pp) 5865770-01086558; qq) 5865770-01086633; rr) 5865770-01086750; ss) 5865770-01087358; tt) 5865770-01087451; uu) 5865770-01087735; vv) 5865770-01088176; ww) 5865770-01088803; xx) 5865770-01090156; yy) 5865770-01090457; zz) 5865770-01090462; aaa) 5865770-01090480; bbb) 5865770-01090911; ccc) 5865770-01092697; ddd) 5865770-01093133; eee) 5865770-01093401; fff) 5865770-01093490; ggg) 5865770-01093491; hhh) 5865770-01093512; iii) 5865770-01093911; jjj) 5865770-01093963; kkk) 5865770-01095002; lll) 5865770-01095003; mmm) 5865770-01095004; nnn) 5865770-01095722; ooo) 5865770-01096224; ppp) 5865770-01096505; qqq) 5865770-01096507; rrr) 5865770-01097422; sss) 5865770-01097466; ttt) 5865770-01097605; uuu) 5865770-01097608; vvv) 5865770-01097609; www) 5865770-01098100; xxx) 5865770-01098101; yyy) 5865770-01098149; zzz) 5865770-01098152; aaaa) 5865770-01098554; bbbb) 5865770-01098564; cccc) 5865770-01098839; dddd) 5865770-01099430; eeee) 5865770-01099480; ffff) 5865770-01099958; gggg) 5865770-01101532; hhhh) 5865770-01103577; iiii) 5865770-01104960; jjjj) 5865770-01105370; kkkk) 5865770-01105397; llll) 5865770-01105426; mmmm) 5865770-01106057; nnnn) 5865770-01106058; oooo) 5865770-01106063; pppp) 5865770-01106392; qqqq) 5865770-01106395; rrrr) 5865770-01106785; ssss) 5865770-01107872; tttt) 5865770-01108428; uuuu) 5865770-01108437; vvvv) 5865770-01108439; wwww) 5865770-01108440; xxxx) 5865770-01108441; yyyy) 5865770-01108729; zzzz) 5865770-01108744; aaaaa) 5865770-01108785; bbbbb) 5865770-01109135; ccccc) 5865770-01109863; ddddd) 5865770-01110047; eeeee) 5865770-01110383; fffff) 5865770-01110384; ggggg) 5865770-01111086; hhhhh) 5865770-01111116; iiiii) 5865770-01111405; jjjjj) 5865770-01112307; kkkkk) 5865770-01112781; lllll) 5865770-01112852; mmmmm) 5865770-01113283; nnnnn) 5865770-01114755; ooooo) 5865770-01115277; ppppp) 5865770-01115278; qqqqq) 5865770-01115283; rrrrr) 5865770-01115304; sssss) 5865770-01115637; ttttt) 5865770-01118674; uuuuu) 5865770-01119976; vvvvv) 5865770-01120050; wwwww) 5865770-01120073; xxxxx) 5865770-01120763; yyyyy) 5865770-01121267; zzzzz) 5865770-01122511; aaaaaa) 5865770-01122678; bbbbbb) 5865770-01123105; cccccc) 5865770-01123107; dddddd) 5865770-01123128; eeeeee) 5865770-01123423; ffffff) 5865770-01123424; gggggg) 5865770-01123482; hhhhhh) 5865770-01123508; iiiiii) 5865770-01123510; jjjjjj) 5865770-01123540; kkkkkk) 5865770-01123543; llllll) 5865770-01123953; mmmmmm) 5865770-01124296; nnnnnn) 5865770-01125177; oooooo) 5865770-01125584; pppppp) 5865770-01125799; qqqqqq) 5865770-01125800; rrrrrr) 5865770-01125801; ssssss) 5865770-01127406; tttttt) 5865770-01127432; uuuuuu) 5865770-01127433; vvvvvv) 5865770-01128035; wwwwww) 5865770-01128294; xxxxxx) 5865770-01128706; yyyyyy) 5865770-01128708; zzzzzz) 5865770-01130685; aaaaaaa) 5865770-01131742; bbbbbbb) 5865770-01132411; ccccccc) 5865770-01132561; ddddddd) 5865770-01132625; eeeeeee) 5865770-01133378; fffffff
FDA Enforcement
Class II
·Ongoing·GE Healthcare Finland Oy·July 3, 2024
CARESCAPE B850 Model Numbers: a) MBC303, Model Numbers: 1) 2078633-001, 2) 2078633-010, 3) 2078633-012, 4) 2078633-017, 5) 2078633-028, 6) 2095802-001-54069330, 7) 2095802-001-554922, 8) 2095802-001-554923, 9) 2095802-001-554924, 10) 2095802-001-554925, 11) 2095802-001-554926, 12) 2095802-001-554927, 13) 2095802-001-554928, 14) 2095802-001-555120, 15) 2095802-001-556223, 16) 2095802-001-557346, 17) 2095802-001-558678, 18) 2095802-001-558707, 19) 2095802-001-559208, 20) 2095802-001-559337, 21) 2095802-001-559916, 22) 2095802-001-560446, 23) 2095802-001-560519, 24) 2095802-001-560520, 25) 2095802-001-560521, 26) 2095802-001-560522, 27) 2095802-001-560637, 28) 2095802-001-560803, 29) 2095802-001-561557, 30) 2095802-001-562090, 31) 2095802-001-562136, 32) 2095802-001-562249, 33) 2095802-001-562799, 34) 2095802-001-563317, 35) 2095802-001-563770, 36) 2095802-001-563771, 37) 2095802-001-564033, 38) 2095802-001-564174, 39) 2095802-001-565603, 40) 2095802-001-566307, 41) 2095802-001-566308, 42) 2095802-001-566696, 43) 2095802-001-566798, 44) 2095802-001-566816, 45) 2095802-001-566825, 46) 2095802-001-566826, 47) 2095802-001-566925, 48) 2095802-001-567844, 49) 2095802-001-568125, 50) 2095802-001-568726, 51) 2095802-001-568765, 52) 2095802-001-569226, 53) 2095802-001-569235, 54) 2095802-001-569318, 55) 2095802-001-569322, 56) 2095802-001-569329, 57) 2095802-001-569332, 58) 2095802-001-569426, 59) 2095802-001-569860, 60) 2095802-001-569871, 61) 2095802-001-569990, 62) 2095802-001-570062, 63) 2095802-001-570185, 64) 2095802-001-570746, 65) 2095802-001-570960, 66) 2095802-001-571048, 67) 2095802-001-571049, 68) 2095802-001-571801, 69) 2095802-001-571807, 70) 2095802-001-572988, 71) 2095802-001-572991, 72) 2095802-001-573205, 73) 2095802-001-574167, 74) 2095802-001-574403, 75) 2095802-001-574569, 76) 2095802-001-574570, 77) 2095802-001-574685, 78) 2095802-001-575604, 79) 2095802-001-575842, 80) 2095802-001-576569, 81) 2095802-001-577254, 82) 2095802-001-577260, 83) 2095802-001-577472, 84) 2095802-001-577688, 85) 2095802-001-578467, 86) 2095802-001-578468, 87) 2095802-001-579029, 88) 2095802-001-579134, 89) 2095802-001-579366, 90) 2095802-001-579526, 91) 2095802-001-579590, 92) 2095802-001-579604, 93) 2095802-001-579692, 94) 2095802-001-579926, 95) 2095802-001-579933, 96) 2095802-001-580487, 97) 2095802-001-580731, 98) 2095802-001-581010, 99) 2095802-001-581094, 100) 2095802-001-581417, 101) 2095802-001-581433, 102) 2095802-001-582510, 103) 2095802-001-582710, 104) 2095802-001-582906, 105) 2095802-001-582907, 106) 2095802-001-583150, 107) 2095802-001-583551, 108) 2095802-001-583553, 109) 2095802-001-583888, 110) 2095802-001-583970, 111) 2095802-001-584288, 112) 2095802-001-584547, 113) 2095802-001-584810, 114) 2095802-001-585047, 115) 2095802-001-585468, 116) 2095802-001-585907, 117) 2095802-001-586028, 118) 2095802-001-586829, 119) 2095802-001-587286, 120) 2095802-001-587726, 121) 2095802-001-587767, 122) 2095802-001-587770, 123) 2095802-001-588006, 124) 2095802-001-588111, 125) 2095802-001-588571, 126) 2095802-001-589110, 127) 2095802-001-589168, 128) 2095802-001-589304, 129) 2095802-001-589326, 130) 2095802-001-589329, 131) 2095802-001-589511, 132) 2095802-001-589655, 133) 2095802-001-589796, 134) 2095802-001-589799, 135) 2095802-001-589801, 136) 2095802-001-589993, 137) 2095802-001-590263, 138) 2095802-001-590270, 139) 2095802-001-590640, 140) 2095802-001-590643, 141) 2095802-001-590645, 142) 2095802-001-590648, 143) 2095802-001-590649, 144) 2095802-001-590651, 145) 2095802-001-590652, 146) 2095802-001-591048, 147) 2095802-001-591102, 148) 2095802-001-591244, 149) 2095802-001-591246, 150) 2095802-001-591718, 151) 2095802-001-592666, 152) 2095802-001-592669, 153) 2095802-001-592683, 154) 2095802-001-592983, 155) 2095802-001-593000, 156) 2095802-001-593024, 157) 2095802-001-593039,
FDA Enforcement
Class II
·Ongoing·GE Healthcare Finland Oy·July 3, 2024
CARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, c) 5939590-102; monitor, physiological, patient
FDA Enforcement
Class II
·Ongoing·GE Healthcare Finland Oy·July 3, 2024
GE Healthcare CARESCAPE Monitor B850 Product Usage: Intended uses of CARESCAPE B850 V2 in 510(k) countries [UR_CRSCP-1046]: The CARESCAPE Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B850 is indicated for monitoring of: -hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation). -Respiratory (impedance respiration, airway gases (CO2, O2, N2O and anesthetic agents), spirometry, gas exchange) and -neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS) and neuromuscular transmission. The CARESCAPE Monitor B850 also provides alarms, trends, snapshots and events, and calculations and can be connected to displays, printers and recording devices.
FDA Enforcement
Class II
·Ongoing·GE Healthcare Finland Oy·October 17, 2018