36 results
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Sources: EU EUDAMED, US FDA
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Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Single Use Electrosurgical Snare Model/Catalog Number: SD-400U-10 Product Description: These instruments have been designed to be used with an Olympus endoscope for the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps, and tissue from within the GI tract.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·November 19, 2025
Brand Name: Olympus Single Use Single Use Electrosurgical Snare SD-400 Product Name: Single Use Single Use Electrosurgical Snare Model/Catalog Number: SD-U400U-15 Product Description: These instruments have been designed to be used with an Olympus endoscope for the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps, and tissue from within the GI tract.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·November 19, 2025
Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor
FDA Enforcement
Class III
·Ongoing·SUREPULSE MEDICAL LTD·February 18, 2026
Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor
FDA Enforcement
Class III
·Ongoing·SUREPULSE MEDICAL LTD·February 18, 2026
Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor
FDA Enforcement
Class III
·Ongoing·SUREPULSE MEDICAL LTD·February 18, 2026
Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor
FDA Enforcement
Class III
·Ongoing·SUREPULSE MEDICAL LTD·February 18, 2026
Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor
FDA Enforcement
Class III
·Ongoing·SUREPULSE MEDICAL LTD·February 18, 2026
Sterile Procedural Trays, labeled as the following: a. PORT/TRACH INSERTION CDS-3 b. RESIDENT DERM SURG PACK c. THROMBECTOMY PACK-LF d. AV FISTULA PACK e. AV SHUNT PACK-LF f. RR-VP SHUNT PACK-LF g. VEIN HARVESTING PACK-LF h. AV FISTULA PACK-LF i. PK, GEN-BARIATRIC j. VEIN PACK k. VENOUS ACCESS PACK-LF l. VENOUS ACCESS PACK m. VASCULAR ACCESS PACK n. ARTERIOGRAM PACK o. AV FISTULA/GRAFT INSER PK p. VEIN ABLATION PACK q. PORT PACK r. MINOR VASCULAR s. FISTULA PACK t. AV FISTULA-LF u. AV FISTULA v. PORT VENOUS ACCESS w. AV FISTULA
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·February 15, 2023
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 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
GE Healthcare CARESCAPE Monitor B450 Product Usage: Intended uses of CARESCAPE B450 in 510(k) countries [UR_CRSCP-885]: The CARESCAPE Monitor B450 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility. The CARESCAPE Monitor B450 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B450 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), and spirometry) -neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission).
FDA Enforcement
Class II
·Ongoing·GE Healthcare Finland Oy·October 17, 2018
GE Healthcare CARESCAPE Monitor B650
FDA Enforcement
Class II
·Ongoing·GE Healthcare Finland Oy·July 11, 2018
TruSignal Adult/Pediatric Sensor; Oximeter, Ear: a) REF TS-AP-10, 10 pcs; b) REF TS-AP-25, 25 pcs
FDA Enforcement
Class I
·Ongoing·GE Healthcare Finland Oy·July 12, 2023
TruSignal Integrated Ear Sensor with GE Connector REF TS-E2-GE; Oximeter, Ear
FDA Enforcement
Class I
·Ongoing·GE Healthcare Finland Oy·July 12, 2023