14 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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Drugs of Abuse Tests: a. Wondfo Tdip Drugs of Abuse Test Tdip Single Drug Fentanyl (FEN) Urine Sample 25 Tests. Model Number: AWFTY-114. b. Alere Drugs of Abuse Test E-Z Split Key Cup 12-Drug Panel AMP, BAR, BUP, BZO, COC, mAMP/MET, MDMA, MOP, MTD, OXY, PPX, THC Urine Sample 25 Tests Model Number: DOA-1127-041-19. c. Instant Technologies, Inc. Drugs of Abuse Test iCup A.D. 5-Drug Panel with Adulterants AMP, COC, mAMP/MET, OPI, THC (OX, pH, SG) Urine Sample 25 Tests Model Number: I-DUA-157-013. d. Instant Technologies, Inc. Drugs of Abuse Test iCup A.D. 6-Drug Panel with Adulterants AMP, BZO, COC, mAMP/MET, OPI, THC, (OX, pH, SG) Urine Sample Tests Model Number: I-DUA-167-022. e. Alere Drugs of Abuse Test iCup Dx Pro 2 10-Drug Panel with Adulterants AMP, BAR, BUP, BZO, COC, mAMP/MET, OPI300, OXY, MTD, THC (CR, OX, SG) Urine Sample 25 Tests Model Number: I-DXP-2107-01. f. Alere Drugs of Abuse Test iScreen 5-Drug Panel AMP, COC, mAMP/MET, OPI, THC Urine Sample 25 Tests Model Number: IS5M. g. Instant Technologies, Inc. Drugs of Abuse Test T-Cube 7-Drug Panel AMP50, COC20, mAMP/MET50, OPI40, OXY20, PCP10, THC40 Saliva Sample 25 Tests Model Number: TCUBE-7PCPB. h. Wondfo Drugs of Abuse Test with Adulterants Tcup 14-Drug Panel AMP1000, BAR300, BZO300, BUP10, COC300, mAMP/MET1000, MDMA500, MTD300, MOP(OPI300), OXY100, PCP25, PPX300, TCA1000, THC50 (CR, pH, SG) Urine Sample 25 Tests Model Number: TDOA-1145A3. i. Instant Technologies, Inc. Drugs of Abuse Test UScreen 12-Drug Panel with Adulterants AMP, BAR, BZO, COC, mAMP/MET, MDMA, MOP, MTD, OXY, PCP, TCA, THC, (CR, pH, SG) Urine Sample 25 Tests Model Number: USSCUPA-12CLIA. j. Instant Technologies, Inc. Drugs of Abuse Test UScreen 12-Drug Panel with Adulterants AMP, BAR, BUP, BZO, COC, mAMP/MET, MDMA, MOP, MTD, OXY, PCP, THC (CR, pH, SG) Urine Sample 25 Tests Model Number: USSCupA-12BUP300. k. Alere Drugs of Abuse Test E-Z Split Key Cup 6-Drug Panel AMP, BZO, COC, mAMP/MET, OPI, THC Urine Sample 25 Tests Model Number: DOA-2167-019. l. Alere Drugs of Abuse Test E-Z Split Key Cup A.D. 5-Drug Panel with Adulterants AMP, COC, mAMP/MET, OPI, THC (CR, GL, NI, OX, pH, SG) Urine Sample 25 Tests Model Number: DUD-157-012-019. m. WONDFO USA CO., LTD. Wondfo Drug Test Dip Card Drugs of Abuse Test Tdip Single Drug Buprenorphine (BUP) Urine Sample 25 Tests Model Number: WDBU-114.
FDA Recall
Open, Classified
·Mckesson Medical-Surgical Inc. Corporate Office
9954 Maryland Drive
Deep Run Iii Ste. 4000
Richmond VA 23233·Product code DKZ·May 25, 2022
API JAMES 2AMP, CATALOG 70542
FDA Recall
Open, Classified
·Biomerieux Inc·Product code JTO·November 9, 2022
API NIT1 NIT2 REAGENTS, CATALOG 70442
FDA Recall
Open, Classified
·Biomerieux Inc·Product code JTO·November 9, 2022
API VP1 VP2 REAGENTS, CATALOG 70422
FDA Recall
Open, Classified
·Biomerieux Inc·Product code JTO·November 9, 2022
API 20 E 25 STRIPS, CATALOG 20100
FDA Recall
Open, Classified
·Biomerieux Inc·Product code JSS·November 9, 2022
API STAPH 25 STRIPS+25 MEDIA, CATALOG 20500
FDA Recall
Open, Classified
·Biomerieux Inc·Product code JWX·November 9, 2022
API LISTERIA 10 STRIPS+10 MEDIA, CATALOG 10300
FDA Recall
Open, Classified
·Biomerieux Inc·Product code JTO·November 9, 2022
API 20 C AUX 25 STRIPS+25 MEDIA, CATALOG 20210
FDA Recall
Open, Classified
·Biomerieux Inc·Product code JXB·November 9, 2022
Centurion STERILE ROUND EAR SPECULUM SET (3, 4, 5), Product Code I68505
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code EPY·February 23, 2024
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2236; 2) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2237M; 3) ECONO STERILE VIENNA NSL SPEC LG STRL CS/25, Model Number 96-2238; for nasal procedures
FDA Recall
Open, Classified
·Sklar Instruments·Product code EPY·December 3, 2024
HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144
FDA Recall
Open, Classified
·Mizuho OSI·Product code LXH·July 29, 2021
Mizuho CE IPX4, mode MOT-5602BW, 100-240, 50-60Hz, 400VA, REF 18-140-20 containing hand control Unit - Product Usage: intended to support a patient during surgical operations.
FDA Recall
Open, Classified
·Mizuho OSI·Product code GDC·February 8, 2021
OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004
FDA Recall
Open, Classified
·OPTI Medical Systems, Inc·Product code QJR·June 25, 2021
UFSK Treatment chair 500 XLE- Treatment chair for positioning and support of the patient during diagnostic and therapeutic treatments of temporary to short-term duration, especially in ophthalmology Art.no. / REF no.: 15000004 Art.no. / REF no.: 15000006
FDA Recall
Open, Classified
·UFSK International OSYS Gmbh Kirchhoffstr. 1 Ratisbon Germany·Product code HME·May 31, 2023