BEUDAMED
    33 results · 6ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Classification: Class Ii × Status: Terminated × Clear all

    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

    EDI BZO UNCUT SHEET-CARD, Item No. 100170 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

    Geo-Med, TURP/CYSTO PACK PGYBK REF 89-7931.07, Rx Only, STERILE EO, Custom surgical kit.

    FDA Enforcement
    Class II ·Terminated·DeRoyal Industries Inc·September 7, 2016

    GEO-MED ORTHO TOTAL JOINT TRACECART(R), REF 53-1831.07, Rx Only, NON-STERILE Product Usage: general surgical

    FDA Enforcement
    Class II ·Terminated·DeRoyal Industries Inc·July 17, 2013

    Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO Use: Shoulder Arthroscopy

    FDA Enforcement
    Class II ·Terminated·DeRoyal Industries Inc·February 28, 2018

    Product Brand Name(s): Innovacon Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug Screen Device with BZO, Reditest On-Site Oral Fluid Drug Screen Device & XALEX One Step Rapid Drug Test. Type of Packaging: 25 individually pouched test devices & collectors in a labeled kit box. The OrALert Oral Fluid Drug Screen Device for AMP/mAMP/COC/OPI/THC/PCP/BZO is an immunoassay based on the principle of competitive binding. Drugs that may be present in the oral fluid specimen compete against their respective drug conjugates for binding sites on their specific antibody.

    FDA Enforcement
    Class II ·Terminated·Alere San Diego, Inc.·January 15, 2014

    Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications

    FDA Enforcement
    Class II ·Terminated·Philips Healthcare Inc.·September 26, 2012

    Henry Schein One Step + DOA Cup (AMT Item Number/ AMT Description): 570-1066 / "Henry Schein OneStep+ DOA Cup 14 Panel AMP500/BAR/BUPG/BZO/COC150/MDMA/MET500/MOP/MTD/OXY/PCP/PPX/TCA/THC (Bl, Cr, Ni, pH, SG)",

    FDA Enforcement
    Class II ·Terminated·Ameditech Inc·October 7, 2020

    Consult Diagnostics Drugs Abuse Test Cup (AMT Item Number/ AMT Description): 164-DXA14 /"Consult Diagnostics DRUGS OF ABUSE TEST CUP 14-DRUG PANEL WITH ADULTERANTS AMP500/BAR/BUPG/BZO/COC150/MDMA/MET500/MOP/MTD/OXY/PCP/PPX/TCA/THC (Bl, Cr, Ni, pH, SG)",

    FDA Enforcement
    Class II ·Terminated·Ameditech Inc·October 7, 2020

    ArcPoint Labs 10 Panel Dip Screen (OXY), Item No. APD-10MO 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

    1 Step 12 Panel Cup, Item No. NBCA-12M-W 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

    Premier Clia Waived 12 panel Tilt Cup, Item No. C12APC 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

    10-Panel Pipette Drug Screen, Item No. PSP-10M 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

    DrugCheck Pipette 10 Drug Test, Item No. 41025 DC 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

    THERMO FISHER 6 DRUG CASSETTE, Item No. MTPA-6MBAU, MTPA-8MBAU 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

    12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP 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