16 results
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7ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to be used to acquire, store, print, transfer, and archive clinical information.
FDA Enforcement
Class II
·Terminated·Merge Healthcare, Inc.·May 31, 2017
iChemVELOCITY, Urine Chemistry System, Catalog numbers: 700-7176-001, 700-7177-001, B75502 - Product Usage: used to automate the urine chemistry analysis profile using iChem¿ VELOCITY Urine Chemistry Strips.
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·February 5, 2020
Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Care PACS. The firm name on the labeling is Merge Healthcare, Hartland, WI.
FDA Enforcement
Class II
·Terminated·Merge Healthcare, Inc.·March 1, 2017
Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs from the Quinton Stress ECG System. Model No. 860426
FDA Enforcement
Class II
·Terminated·Philips Medical Systems, Inc.·August 27, 2014
iQ200 Series Urine Microscopy Analyzer, Catalog numbers: 700-3345, 700-3375, 700-3325, 700-3347, 700-3300RFB, 700- 3320, 700-3320RFB, 700-3322, 700-3322RFB, 700-3326, 700- 3340, 700-3370, B48999, C10683, C10684 - Product Usage: device used to automate the complete urinalysis profile, including urine test strip chemistry panel and microscopic sediment analysis.
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·February 5, 2020
Medline Convenience Kits: 1) TRUNK KIT W/EXPIRATION, Model Number: DYKM1361A; 2) TRUNK KIT 1EA, Model Number: DYKM2013; 3) TRUNK KIT 1EA, Model Number: DYKM2013A; 4) RN TRUNK KIT, Model Number: DYKM2699; 5) TRUNK KIT, Model Number: DYKTRUNK1
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·March 4, 2026
Century Console Base, Model #043625051b. Intended for use as a platform for other ancillary equipment and disposable products in cardiopulmonary surgical procedures.
FDA Enforcement
Class II
·Terminated·Salyer Prn Biomedical·March 13, 2013
T/S2 0.9% Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, 10 mL in 12 mL Single Use Syringe, Rx only, Part no. 2S0706 Usage: Flush syringe.
FDA Enforcement
Class II
·Terminated·MRP, LLC dba AMUSA·June 24, 2015
0.9% Sodium Chloride Injection, USP, Flush Syringe, 10 mL in 12 mL, Sterile, Rx only, Code No. 2T0806 Usage: Flush syringe.
FDA Enforcement
Class II
·Terminated·MRP, LLC dba AMUSA·June 10, 2015
0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution.
FDA Enforcement
Class II
·Terminated·MRP, LLC dba AMUSA·September 2, 2015
AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringe, USP, 5mL in 12mL, REF 2T0805; and 3mL in 12mL, REF 2T0807, intermediate cartons containing 100 syringes, shipping cases containing 400 syringes, Rx, Sterile.
FDA Enforcement
Class II
·Ongoing·MRP, LLC dba Aquabiliti·February 28, 2024
NavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, NPFS-02010, NPFS 02020.
FDA Enforcement
Class II
·Terminated·Blue Belt Technologies MN·May 21, 2014
Stride Femoral Component Size 2, PFSI-00054, Right Medial /Left Lateral. Unicondylar Knee prosthesis.
FDA Enforcement
Class II
·Terminated·Blue Belt Technologies MN·July 9, 2014
Stride Femoral Component Size 2, PFSI-00053, Right Lateral /Left Medial. Unicondylar Knee prosthesis.
FDA Enforcement
Class II
·Terminated·Blue Belt Technologies MN·July 9, 2014
Blue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile EO. Product Usage: The intended use of this device is t protect equipment from contamination during a variety of procedures throughout the clinical setting.
FDA Enforcement
Class II
·Terminated·Blue Belt Technologies MN·August 28, 2013
Procedure packs: (1) Presource PBDS Cat. PN33BPCR2, Kit, Back, Sterile; (2) Presource PBDS Cat. POCGANA11, Kit, ARN Anterior Hip, Sterile; (3) Presource PBDS Cat. PODKHAKAB, Kit, Hip Arthroscopy, Sterile; (4) Presource PBDS, Cat. POMHKAESV, Kit, Knee Arthroscopy, SE, Sterile; (5) Presource PBDS Cat. POMHLEE11, Kit, Extremity, SE, Sterile; (6) Presource PBDS Cat. POMVTHANLE, Kit, Anterior Hip, Sterile; (7) Presource PBDS Cat. POVMPAB11, Kit, PAO Pack, Barnes Jewish, Sterile; (8) Presource PBDS Cat. PO08LXG21, Kit, Extremity, Grant, Sterile; (9) Presource PBDS Cat. PO11HRFH6, Kit, Anterior Hip, Sterile; (10) Presource PBDS Cat. PO11OTASS8, Kit, Trauma Hip A and B, Sterile; (11) Presource PBDS Cat. PO11OTSSP, Kit, Trauma Knee A and B, Sterile; (12) Presource PBDS Cat. PO11THAS13, Kit, Anterior Hip, Sterile; (13) Presource PBDS Cat. PO12AHSUQ, Kit, Anterior Hip, Sterile; (14) Presource PBDS Cat. PO12AHSU7, Kit, Anterior Hip, Sterile; (15) Presource PBDS, Cat. PO18AHEFG, Kit, Anterior Hip, Sterile; (16) Presource PBDS Cat. PO3LHPLM2, Kit, Hip Pinning, Sterile; (17) Presource PBDS Cat. PO3LHPLM3, Kit, Hip Pinning, Sterile; (18) Presource PBDS Cat. PO33AHCRA, Kit, Anterior Hip, Sterile; (19) Presource PBDS Cat. PO56MLGRA, Kit, MC Lower Extremity, Sterile; (20) Presource Spine Pack, Cat. SNECGSPAHB,Sterile; (21) Presource Spine Pack, Cat. SNECGSPAH4, Sterile; (22) Presource Ortho Laminectomy Pack, Cat. SNE12OL89A, Sterile; (23) Presource ACD Pack, Cat. SNE33ACCRD, Sterile; (24) Presource Anterior Fusion Pack, Cat. SNE33AFC18, Sterile; (25) Presource Lumbar Disk Pack, Cat. SNE33LMCAB, Sterile; (26) Presource SDMC Ortho Spine Accessory Pk, Cat. SNE73SAKSD, Sterile; (27) Presource Hip Arthroscopy Pack, Cat. SOPCNHAMSD, Sterile; (28) Presource Anterior Approach Total Hip Pk, Cat. SOPDKAHC12, Sterile; (29) Presource Physician Partner of America, Cat. SOPHFLSHAC, Sterile; (30) Presource MH Hip With Curtain Std Pack, Cat. SOPMHHCM10, Sterile; (31) Presource Back Pack, Cat. SOPOCBPLSD, Sterile; (32) Presource HFHS Ortho Spine Pack, Cat. SOPW1OSHFM, Sterile; (33) Presource PED Extremity Pack, Cat. SOP11PER12, Sterile; (34) Presource Hip Arthroscopy Pack, Cat. SOP12HAGTC, Sterile; (35) Presource OPSC Hip Arthroscopy Pack, Cat. SOP12HAUVE, Sterile; (36) Presource Major Ortho, Cat. SOP12MJHM6, Sterile; (37) Presource Pedi Ortho Spine W Basin Pack, Cat. SOP22PSMRE, Sterile; (38) Presource Lower Extremity Pack 302095, Cat. SOP3LLESGK, Sterile; (39) Presource ORIF Wrist Sturgeon Pack, Cat. SOP30ACSCG, Sterile; (40) Presource Ensemble Pied Cheville 3, Cat. SOP30AKJTF, Sterile; (41) Presource Fracture Pack, Cat. SOP30FRUHE, Sterile; (42) Presource Anterior Total Hip Pack, Cat. SOP30HALHB, Sterile; (43) Presource Hip Pack, Cat. SOP30HPWME, Sterile; (44) Presource Hip Scope Pack, Cat. SOP30HSCHE, Sterile; (45) Presource Ortho Split Pack, Cat. SOP30OSVI8, Sterile; (46) Presource Pack Trauma Uppr Extrmty Civic, Cat. SOP30UPOHD, Sterile; (47) Presource Anterior Hip Pack, Cat. SOP32AHGMH, Sterile; (48) Presource Anterior Tha Pack, Cat. SOP33ANOOI, Sterile; (49), Presource CPT Ortho Custom UH Pack, Cat. SOP33OROUJ, Sterile; (50) Presource CPT Ortho Custom UH Pack, Cat. SOP33OROU5, Sterile; (51) Presource Anterior Hip Pk, Cat. SOP35AHAMG, Sterile; (52) Presource Hip Pack, Cat. SOP41HISP6, Sterile; (53) Presource Spine Tray, Cat. SOP44STHPC, Sterile; (54) Presource Anterior Hip Pack, Cat. SOP5BAHHEE, Sterile; (55) Presource Essentia Anterior Hip Surgi Pk, Cat. SOP5BHSEHD, Sterile; (56) Presource CPT Ortho Custom James Pk, Cat. SOP5CCJOUH, Sterile; (57) Presource Back Part 1, Cat. SOP51BAKOF, Sterile; (58) Presource Back Part 1, Cat. SOP51BAKO9, Sterile; (59) Presource Pack Total Hip Anter Surg WMC, Cat. SOP53APKP4, Sterile; (60) Presource West Hip Anterior Total Pack, Cat. SOP56HAMT8, Sterile; (61) Presource Anterior Hip Pack, Cat. SOP57AHSH5, Sterile; (62) Presource Total Hip Pack, Cat. SOP6VTHPOA, Sterile; (63) Presource ASU Hip Arthroscopy Pack, Cat. S
FDA Enforcement
Class II
·Ongoing·Cardinal Health 200, LLC·October 18, 2023