40 results
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end of the endoscope. Disposable EMR Kit: K-001, K-002, K-003, K-004, K-011, K-012
FDA Enforcement
Class II
·Ongoing·Aomori Olympus Co., Ltd.·September 13, 2023
LithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30. Single Use Mechanical Lithotriptor V used with Olympus endoscope for crushing calculi inside the bile duct.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·January 22, 2025
Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.A
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·June 28, 2023
Single Use Repositionable Clip QUICKCLIP PRO 165CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.B
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·June 28, 2023
IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2KUN6;
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·November 19, 2025
Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use Electrosurgical Knife KD-645 Model/Catalog Number: KD-645L Product Description: An electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver a current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·February 11, 2026
Single Use Repositionable Clip QUICKCLIP PRO 230CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202UR.B
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·June 28, 2023
Single Use Repositionable Clip QUICKCLIP PRO 230 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202UR.A
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·June 28, 2023
Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife KD-640L Model/Catalog Number: KD640-L Product Description: An electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver a current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·February 11, 2026
Artix MT Thrombectomy Device, REF: 32-102
FDA Enforcement
Class II
·Ongoing·Inari Medical - Oak Canyon·May 14, 2025
ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever Thrombectomy System, Reference: IU-01011
FDA Enforcement
Class I
·Ongoing·Inari Medical - Oak Canyon·August 28, 2024
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