52 results
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14ms
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Sources: EU EUDAMED, US FDA
GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System
FDA Enforcement
Class II
·Ongoing·GRAMERCY EXTREMITY ORTHOPEDICS·April 26, 2023
Custom surgical kits and trays: GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.04 GEO-MED TOTAL HIP PACK, REF 89-6664.03 surgical kits
FDA Enforcement
Class II
·Terminated·DeRoyal Industries Inc·July 25, 2012
ProScreen" Drugs of Abuse Test (AMT Item/ AMT Description): PSD-6MB/ "ProScreen" Drugs of Abuse Test (MET1000/OPI2000)+AMP+BZO+COC+THC", PSD-6MTDBO-300 /"ProScreen" Drugs of Abuse Test (COC/THC)+BZO+MTD+OPI300+OXY", PSCUP-5M-W/ ProScreen" Drugs of Abuse Cup AMP/COC/MET1000/OPI2000/THC), PSD-10MOB "ProScreen" Drugs of Abuse Test (COC/THC)+(MET1000/OPI2000)+(OXY/ MDMA)+AMP+BZO+BUP+MTD", PSD-5M / "ProScreen" Drugs of Abuse Test AMP/COC/MET1000/OPI2000/THC", PSCUPA-10OM / ProScreen" Drugs of Abuse Cup (COC/THC)+(MET1000/OPI2000)+(OXY/ MDMA) +(PCP/AMP)+BAR+BZO
FDA Enforcement
Class II
·Terminated·Ameditech Inc·October 7, 2020
DrugSmart Dip (MET/OPI2)+AMP+BZO+COC+THC, Item No. 30600D; DrugSmart Dip AMP/OPI2/COC/THC/BZO Test, Item No. 30520D These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.
FDA Enforcement
Class II
·Terminated·Ameditech Inc·November 25, 2015
Alere iCup Drug Detection (AMT Item Number/ AMT Description): I-DXA-10/ "Alere" iCup¿ Dx 10 Drug Detection + Adulteration AMP/BAR/BZO/COC/MET/MDMA/MTD/MOP/OXY/THC Bl, Cr, Ni, pH, SG", I-DXA-13B/"Alere" iCup¿ DX Drug Screen Cup 13 Drug Detection + Adulteration AMP/BAR/BZO/BUPG/COC/MET/MDMA/MTD/MOP/OXY/PCP/THC/TCA Bl, Cr, Ni, pH, SG", I-DXA-1127-023-N "Alere" iCup¿ Dx Drugs of Abuse Test (COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+ (OXY/MDMA)+(PCP/AMP)+BAR+BZO With Cr, Ni, pH, Bl, S.G."
FDA Enforcement
Class II
·Terminated·Ameditech Inc·October 7, 2020
Drug Screening Component: Uncut Sheets Part Number/ Description/ LOT Number 100163/ EDI OPI (300) Uncut Sheet-Card /187876, 100195/ EDI PPX Uncut Sheet-Card/ 187877, 160130/ EDI COC Uncut Sheet-Cup/ 188168, 160180/ EDI PCP Uncut Sheet-Cup/ 189027, 160140/ EDI THC Uncut Sheet Cup /189028, 160170/ EDI BZO Uncut Sheet-Cup/ 189081, 160120/ EDI MET1000 Uncut Sheet-Cup/ 189082, 160160/ EDI OPI2000 Uncut Sheet-Cup / 189123, 160130/ EDI COC Uncut Sheet-Cup/ 189124, 160160/ EDI OPI2000 Uncut Sheet-Cup/ 189166, 160163/ EDI OPI (300) Uncut Sheet-Cup/ 189191, 160110/ EDI AMP Uncut Sheet-Cup/ 189371, 160140/ EDI THC Uncut Sheet Cup/ 189372, 160123/ EDI MET(300) Uncut Sheet-Cup/ 189425, 160170/ EDI BZO Uncut Sheet-Cup/ 189426, 100163/ EDI OPI (300) Uncut Sheet-Card/ 189456, 160170/ EDI BZO Uncut Sheet-Cup/ 189565, 160180/ EDI PCP Uncut Sheet-Cup/ 189601, 160125/ EDI MET(500) Uncut Sheet-Cup/ 189748, 160130/ EDI COC Uncut Sheet-Cup/ 189786, 160160/ EDI OPI2000 Uncut Sheet-Cup / 189844, 160180/ EDI PCP Uncut Sheet-Cup/ 189937, 160172/ EDI BZO(200) Uncut Sheet-CUP/189956 Updated 09/03/2020: EDI Affected products -Catalog Numbers/ Lot Numbers 31105-3/ PI-01081 60503s-3ZC/ PH-10132 60600/ PH-11005
FDA Enforcement
Class II
·Terminated·Ameditech Inc·October 7, 2020
GEO-MED CATARACT PACK, REF 89-5790.08
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED BIOPSY TRAY, REF 89-8753.01
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED OPTHALMOLOGY CSTM PCK, REF 89-6387.08
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED PODIATRY PACK PGYBK, REF 89-6240.05
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED OPTHALMOLOGY CSTM PCK, REF 89-6387.09
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED PODIATRY PACK PGYBK, REF 89-8700.02
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED LOWER EXTERMITY PACK, REF 89-8252.02
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED LOCAL ANESTHESIA PACK, REF 89-10800.01
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED KNEE ARTHROSCOPY PACK, REF 89-5795.07
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED UPPER EXTERMITY PACK, REF 89-8253.02
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED PODIATRY PACK PGYBK, REF 89-8700.01
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED PLASTIC HAND PACK RF, REF 89-6667.09
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED PLASTIC HAND PACK RF, REF 89-6667.10
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED SHOULDER ARTHROSCOPY KNEE PACK, REF 89-5797.09
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022