898 results
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16ms
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Sources: EU EUDAMED, US FDA
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8mm HTR Sterile Hammer Toe Reaming Kit, Material: Stainless Steel, Sterile: R, PX only, UDI: (01)00812926022345(17)231225 (10)TSL007202
FDA Enforcement
Class II
·Terminated·Trilliant Surgical, LLC·April 8, 2020
Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the Medrad¿ Avanta Injection System; Catalog number: AVA 500 MPAT (Part 2 of 2); Affected material numbers: 87629007, 60729458, 86566648;
FDA Enforcement
Class II
·Ongoing·Bayer Medical Care, Inc.·June 10, 2026
Hydroxybutyrate LiquiColor Tests - includes 3 bottles (1 of each size, 3mL, 8.5mL, and 50mL)
FDA Enforcement
Class II
·Terminated·MEDLINE INDUSTRIES, LP - Northfield·April 20, 2022
nanoDot B - item 2 of 3 for 03500-000, Model Number 03502-000; radiation monitoring dosimeter used with the microSTAR readers
FDA Enforcement
Class II
·Completed·Landauer·September 20, 2023
nanoDot A - item 1 of 3 for 03500-000, Model Number 03501-000; radiation monitoring dosimeter used with the microSTAR readers
FDA Enforcement
Class II
·Completed·Landauer·September 20, 2023
nanoDot C - item 3 of 3 for 03500-000, Model Number 03503-000; radiation monitoring dosimeter used with the microSTAR readers
FDA Enforcement
Class II
·Completed·Landauer·September 20, 2023
Dual Delivery 4DD-1 of GYC-1000 Green Laser Photocoagulator system GYC4DD-1: The Nidek Green Laser Photocoagulator Model GYC- 1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
FDA Enforcement
Class II
·Terminated·Nidek Inc·July 22, 2015
Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser Photocoagulator System; GYC4EP-01 0W02 and GYC4EP-1 0Z20; The Nidek Green Laser Photocoagulator Model GYC- 1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
FDA Enforcement
Class II
·Terminated·Nidek Inc·July 22, 2015
Procedure packs: (1) Presource PBDS, Cat. PC71EXOU7, Ohio State Univ Wexner Med Ctr, Kit, Extraction Ross, Sterile; (2) Presource PBDS, Cat. PVOCMVBLC, Bellevue Hospital Center, Kit, Endovascular. (3) Presource PBDS, Cat. PVRMMVAOH7, Regional Medical Center of, Kit, Dr. Ross Minor Vascular, Sterile; (4) Presource PBDS, Cat. PV30VPUHA, Univ Hlth Net Toronto Gen Hosp, Kit, Tavi, Sterile; (5) Presource Cat Pack, Cat. SANOCCPDM2, DMAC Vascular Lab LLC, Sterile; (6) Presource Pacemaker Pack, Cat. SAN1FPMULM, U of L Health, Sterile; (7) Presource OR Angio Pack, Cat. SAN11OADMM, Suny Downstate, Sterile; (8) Presource Device Implant Pack, Cat. SAN13DILCO, BILH Lahey Hospital Burlington, Sterile; (9)Presource Device Implant Pack, Cat. SAN13DILC6, BILH Lahey Hospital Burlington, Sterile; (10) Presource AOG Pack, Cat. SAN21AO62F, CHI Memorial Hospital Chattano, Sterile; (11) Presource Angio Pack, Cat. SAN21APJCD, Ballad Health, Sterile; (12) Presource Implant Pack, Cat. SAN21IP62I, CHI Memorial Hospital Chattano, Sterile; (13) Presource Pacemaker Pack, Cat. SAN23CMCW5, Catawba Valley Medical Center, Sterile; (14) Presource Pacemaker Pk, Cat. SAN29PCCCL, Cleveland Clinic Health System, Sterile; (15) Presource Permanent Pacing Drape Pack, Cat. SAN3BPDKOC, KP Oakland Med Center, Sterile; (16) Presource Permanent Pacing Drape Pack, Cat. SAN3BPDK12, KP Oakland Med Center, Sterile; (17) Presource Femoral Angioplasty, Cat. SAN30ANTHD, Trillium Health Centre, Sterile; (18) Presource VGH Pacemaker Pack, Cat. SAN30PPVGA, Vancouver General Hospital, Sterile; (19) Presource Cat Lab Implant Pack, Cat. SAN32IPJWA, Jewish Hospital, Sterile; (20) Presource Thomas Health System Cath Pack, Cat. SAN33HCSFI, St. Francis Hospital, Sterile; (21) Presource Pacemaker Pack, Cat. SAN33PMDWI, Doctors Hospital, Sterile; (22) Presource OR Percutaneous Pack, Cat. SAN53OPVMG, Virginia Mason Medical Center, Sterile; (23) Presource Pacemaker Pack, Cat. SAN55PMMMK, KP Maui Memorial Medical Cente, Sterile; (24) Presource Pacemaker Pack, Cat. SAN55PMMM9, KP Maui Memorial Medical Cente, Sterile; (25) Presource Pacemaker Insertion Pack, Cat. SAN57PM80G, Salem Health, Sterile; (26) Presource Endovascular Pack, Cat. SAN69ENKBK, KP Baldwin Park Med Cntr, Sterile (27) Presource Vascular Procedure Pack, Cat. SCVOCVACMI, Starling Physicians Access Cen, Sterile; (28) Presource HFHS Vasc Access Endo Vasc Pk, Cat. SCVW1VAHFL, Henry Ford Health System, Sterile; (29) Presource AV Access Pack, Cat. SCV11AVDMF, Suny Downstate, Sterile; (30) Presource AV Access Pack, Cat. SCV11AVD13, Suny Downstate, Sterile; (31) Presource TAVR Bundle Pack, Cat. SCV11TBTJH, Part 1 of 2 and Part 2 of 2, Thomas Jefferson University, Sterile; (32) Presource EVAR, Cat. SCV30EVTHE, Trillium Health Centre, Sterile; (33) Presource RHS Pacemaker, Cat. SCV30PMRGA, Richmond Hospital, Sterile; (34) Presource Perc Pack, Cat. SOT30PCHSC, Health Science Centre, Sterile.
FDA Enforcement
Class II
·Ongoing·Cardinal Health 200, LLC·October 18, 2023
CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782
FDA Enforcement
Class II
·Terminated·Cytocell Ltd.·December 7, 2022
10-Panel Pipette Drug Screen, Item No. PSP-10M
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
ProScreen 12 Panel Dip Card, Item No. PSD-12BUP
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
ProScreen 9 Panel Cup w/Adulterants, Item No. PSCUPA-9BO300
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
DrugSmart 9 Test Cup (BUP), Item No. 60960D
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
RealityCHECK Tilt Cup 12 Panel + Adult, Item No. RC12TCA
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
THERMO FISHER 8 DRUG CASSETTE, Item No. MTPA-8MBAU
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
11 Panel Card (OPI 300) w/Adult, Item No. 71125AA
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
ProScreen CLIA Waived Cup with 8 Drug, Item No. PSCup-8P-W
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
11 Panel Dip Card (OPI 300) w/Adult, Item No. 11125AA
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
1 Step 12 Panel Cup, Item No. NBCA-12M-W
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015