BEUDAMED
    10 results · 7ms · 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 ×

    IUD Insertion Pack

    FDA Enforcement
    Class II ·Ongoing·Stradis Medical, LLC dba Stradis Healthcare·October 27, 2021

    IUD Insertion Kit

    FDA Enforcement
    Class II ·Ongoing·Stradis Medical, LLC dba Stradis Healthcare·October 27, 2021

    Standard IUD Insertion Kit

    FDA Enforcement
    Class II ·Ongoing·Stradis Medical, LLC dba Stradis Healthcare·October 27, 2021

    The RIO (TGS 2.), Model # MAKO TGS 2.0 (Part No. 204000). The RIO is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The RIO is indicated for use in surgical knee and hip procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include: Unicondylar knee replacement (UKA) and/or Patellofemoral knee replacement (PKA) and Total Hip Arthroplasty (THA).

    FDA Enforcement
    Class II ·Terminated·Mako Surgical Corporation·November 28, 2012

    ST IUD REMOVAL HOOK 10" (504090), Medline Item No. I68785

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·January 1, 2025

    ECONO STERILE medical procedure kits labeled as: ECONO STERILE IUD EXTRACTOR DBL HK 10.5"CS25, Model Number 96-4146A

    FDA Enforcement
    Class II ·Ongoing·Sklar Instruments·January 22, 2025

    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 Enforcement
    Class II ·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·August 31, 2022

    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. AAA PACK, Model Number: DYNJ44847I; b. ABDOMINAL VASCULAR PACK, Model Number: DYNJ82578; c. ABDOMINAL VASCULAR-LF, Model Numbers: DYNJ905291B, DYNJ905291C; d. ABLATION PACK, Model Number: DYNJ61957A; e. ACCESSORY OPEN HEART PACK, Model Number: DYNJ36600F; f. ADULT CORONARY PACK, Model Numbers: DYNJV0275J, DYNJV0275K, DYNJV0275L, DYNJV0275M; g. AFIB PACK, Model Number: DYNJ69682; h. ALT MINOR VASCULAR CDS, Model Number: CDS840493F; i. ANGIO-VASCULAR, Model Number: DYNJ24272C; j. ARM VASCULAR-LF, Model Number: DYNJ905290D; k. ARTERIAL/VENOUS ACCESS TRAY, Model Number: DYNDC3038; l. ARTERIOGRAM PACK, Model Numbers: DYNJ81636, DYNJ81636A; m. ARTERIOGRAM PACK 2, Model Number: DYNJ83051; n. AUD MAJOR VASC PK-LF, Model Number: DYNJ40728D; o. AUD MAJOR VASCULAR-LF, Model Number: DYNJ40728A, DYNJ40728B, DYNJ40728C; p. AV FIST PACK, Model Number: DYNJ83462; q. AV FISTULA, Model Numbers: DYNJ64143B, DYNJ905219B, DYNJ905219C, DYNJ905219D; DYNJ905219F, DYNJ906341D, DYNJ906945A, DYNJ907975, DYNJ907975B, DYNJ908096; r. AV FISTULA CAROTID PACK, Model Number: DYNJ82570; s. AV FISTULA PACK, Model Number: DYNJ52093J, DYNJ62218B, DYNJ66184A, DYNJ66184B, DYNJ67178A, DYNJ69443A, DYNJ69443B, DYNJ69443D, DYNJ69489A, DYNJ81033, DYNJ81605, DYNJ82477; t. AV FISTULA PACK-LF, Model Number: DYNJ64499B, DYNJ64499D, DYNJ69167A, DYNJ69167C; u. AV FISTULA VASCULAR, Model Number: DYNJ67340; v. AV GRAFT, Model Number: DYNJ903457D; w. AV GRAFT-LF, Model Number: DYNJ40077F; x. BAPTIST SOUTH OPEN HEART CV PK, Model Number: CDS983147F, CDS983147I; y. BEDSIDE PICC CDS, Model Number: CDS984642; z. BGMC CAROTID MAJOR VASCULAR, Model Number: DYNJ907339; aa. C V MAJOR PACK, Model Number: DYNJ64861A; bb. C V MINOR PACK, Model Number: DYNJ64862B; cc. CABG, Model Numbers: DYNJ906878A, DYNJ9372030F, DYNJ9372030G; dd. CABG HEART CDS, Model Number: CDS985384C; ee. CABG PACK, Model Numbers: DYNJ0408782AA, DYNJ53827, DYNJ59036B, DYNJ59036C, DYNJ59036D, DYNJ59036F; ff. CABG PACK NTX, Model Numbers: DYNJ68389, DYNJ68389A; gg. CARDIAC A B PACK-LF, Model Number: DYNJV0177AG; hh. CARDIAC A & B PACK-LF, Model Number: DYNJV0177AG; ii. CARDIAC CABG B, Model Numbers: DYNJ908121A, DYNJ908121B; jj. CARDIAC CABG PACK, Model Number: DYNJ903072R; kk. CARDIAC CATH PACK, Model Number: DYNJ41195D; ll. CARDIAC EP PACK-LF, Model Numbers: DYNJ0429185K, DYNJ0429185M; mm. CARDIAC ROBOT PACK, Model Number: DYNJ66254A; nn. CARDIOLOGY EP, Model Number: DYNJ59968; oo. CARDIOVASCULAR PT 2, Model Numbers: DYNJ905516C, DYNJ905516D, DYNJ905516F; pp. CAROTID DR WILLIAMS, Model Numbers: DYNJ906351B, DYNJ906351D; qq. CAROTID ENDARTERECTOMY, Model Number: DYNJ905640A; rr. CAROTID PACK, Model Numbers: DYNJ0810062AI, DYNJ0810062AJ, DYNJ39488G, DYNJ66190A, DYNJ66190B, DYNJ66190C, DYNJ80346A; ss. CAROTID PACK-LF, Model Number: DYNJ57646C; tt. CAROTID SUPPLY PACK, Model Number: DYNJ81369; uu. CAROTID VASCULAR PACK, Model Number: DYNJ44927F; vv. CAROTID-LF, Model Number: CDS984764F, DYNJ901745K; ww. CATH LAB PACK, Model Number: DYNJ57735F; xx. CATH PACK, Model Number: DYNJ59830A; yy. CLOVIS CATH LAB PACK, Model Number: DYNJ62379A; zz. CT CABG-LF - IFCAP 7279, Model Number: DYNJC9258G; aaa. CUH OPEN HEART A B C - CDS, Model Number: CDS983202F, CDS983202G, CDS983202I; bbb. CUSTOM CARDIAC CABG, Model Number: DYNJ906108A, DYNJ906108B, DYNJ906108C; ccc. CV AAA PACK W AUX, Model Number: DYNJ65710A; ddd. CV CDS, Model Number: CDS985395D; eee. CVOR ANGIOGRAPHY PACK, Model Number: DYNJ83432; fff. CVOR ENDOVASCULAR PACK, Model Number: DYNJ64506A; ggg. CVP PACK, Model Numbers: DYNJ46359C, DYNJ46359D; hhh. DBD-ABDOMINAL VASCULAR-LF, Model Number: DYNJ905291C; iii. DBD-ALT MINOR VASCULAR CDS, Model Number: CDS840493F; jjj. DBD-ALT MINOR VASCULAR CDS, Model Number: CDS840493F; kkk. DBD-AV FISTUL

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·August 9, 2023

    Centurion-Pelvic PE120 LARGE/MEDIUM PELVIC TRAY PE2200 PELVIC EXAM TRAY PE2200 PELVIC EXAM TRAY PE2400 PELVIC EXAM TRAY PE2515 SMALL GYN EXAM TRAY PE2515 SMALL GYN EXAM TRAY PE2610 PELVIC EXAM TRAY PE2700 ULTRASOUND TRAY PE2700 ULTRASOUND TRAY PE2820 VAG/VIRGIN VAG EXAM TRAY PE2835 PELVIC EXAM TRAY PE2835 PELVIC EXAM TRAY PE2905 HSG TRAY PE2955 7PELVIC EXAM TRAY PE2965 DISPOSABLE PELVIC EXAM TRAY PE2965 DISPOSABLE PELVIC EXAM TRAY PE3125 PELVIC EXAM TRAY PE3195 PELVIC EXAM TRAY PE3285 PELVIC EXAM TRAY PE3360 PELVIC EXAM TRAY W/LIGHT PE3375 PELVIC EXAM TRAY PE3400 MEDIUM GYN EXAM TRAY PE3475 IUD TRAY PE3585 MEDIUM/LARGE PELVIC EXAM TRAY PE860 VAGINAL BLEEDER KIT

    FDA Enforcement
    Class II ·Terminated·Centurion Medical Products Corporation·February 12, 2020

    Centurion-Surgical Tray MNS10255 DELIVERY TRAY MNS10255 DELIVERY TRAY MNS10310 MEATOTOMY TRAY MNS10310 MEATOTOMY TRAY MNS10525 DELIVERY INSTRUMENT TRAY MNS10620 PACEMAKER TRAY MNS10820 ENT/EPISTAXIS KIT MNS10920 PODIATRY NAIL PACK MNS10985 CERCLAGE REMOVAL KIT MNS11020 VAGINAL DELIVERY TRAY MNS11040 OB DELIVERY PROCEDURE PACK MNS11040 OB DELIVERY PROCEDURE PACK MNS11180 CUTDOWN TRAY MNS11380 CYSTO PROCEDURE KIT MNS11415 BIRTHING SET MNS11430 MYELOGRAM TRAY MNS11485 DERM ROOM TRAY MNS11490 VASECTOMY TRAY MNS11490 VASECTOMY TRAY MNS11605 STERILE FLUORO SSP TRAY MNS11720 OCULOPLASTICS INSTRUMENT SET MNS11780 MOHS INSTRUMENT PACK MNS11885 OB BASIC DELIVERY INSTRUMENT TRAY MNS11980 DERMATOLOGY TRAY MNS12045 LINE REPAIR KIT MNS12090 TOENAIL REMOVAL PACK MNS12140 HAND TRAY MNS12175 PACEMAKER TRAY MNS1320 E.N.T. TRAY MNS1445 VASECTOMY MNS1485 NOSEBLEED TRAY MNS1500 JOINT ASPIRATION KIT MNS1500 JOINT ASPIRATION KIT MNS1545 LATEX FREE NASAL HEMORRHAGE SET MNS1555 EPISTAXIS TRAY MNS1900 NOSEBLEED TRAY MNS1990 NASAL KIT MNS2105 EPISTAXIS TRAY MNS2170 NASAL PACKING TRAY MNS2225B MYELOGRAM TRAY MNS2225B MYELOGRAM TRAY MNS2845 U/S, BASIC BIOPSY TRAY MNS2975 ENT EPISTAXIS TRAY MNS3345A PEDIATRIC CUTDOWN TRAY MNS3450 IUD TRAY MNS3490 CHEMO KIT MNS3925 OB INSTRUMENT TRAY MNS4090A MINOR CUTDOWN TRAY MNS4110 THORACOTOMY TRAY MNS4120 NOSEBLEED TRAY MNS4215 OR VAGINAL DELIVERY TRAY MNS4360 BREAST BIOPSY KIT MNS4405 BIOPSY DERMATOLOGY KIT MNS4545 NASAL TRAY MNS4855 WOUND EXPLORATION/DPL TRAY MNS5170 NEONATAL PROCEDURE TRAY MNS5225 RENAL BIOPSY TRAY MNS5272 OB DELIVERY INSTRUMENT TRAY MNS5410 VAG DELIVERY INSTRUMENTS MNS5410 VAG DELIVERY INSTRUMENTS MNS5425 VAGINAL DELIVERY TRAY MNS5511 ARTHROGRAM TRAY MNS5575 OB DELIVERY TRAY MNS5750A VAGINAL DELIVERY SET MNS6025 GU MEATOTOMY MNS6025 GU MEATOTOMY MNS6260 BIOPSY TRAY MNS6285 MINOR PLASTIC SET MNS6395 VAGINAL DELIVERY KIT MNS6405 MULTI-PURPOSE RADIOLOGY TRAY MNS6820 RADIOLOGIST SPINAL TRAY MNS6880 BIOPSY TRAY MNS6985 PERCUTANEOUS CATHETER PLACEMENT TRAY MNS7155 TONGUE TIE KIT MNS7285 BIOPSY KIT- SHAVE MNS7285 BIOPSY KIT- SHAVE MNS7285 BIOPSY KIT- SHAVE MNS7295 BIOPSY KIT - SHAVE/PUNCH COMBO MNS7325 CATHETER REMOVAL TRAY MNS7415 NASAL HEMORRHAGE TRAY MNS7415 NASAL HEMORRHAGE TRAY MNS7575 MINOR TISSUE TRAY MNS7605 BREAST BIOPSY KIT MNS7815 DERMAL PACK MNS7900 C.T. BIOPSY TRAY MNS8010 EPISTAXIS TRAY MNS8445 SPINAL TRAY MNS8445 SPINAL TRAY MNS8475 ED TRACHEOTOMY TRAY MNS8645 BIOPSY KIT MNS8645 BIOPSY KIT MNS8915 BLOOD CULTURE COLLECTION KIT ; CVAD MNS9005 CENTRAL LINE REMOVAL TRAY MNS9106 ULTRASOUND BIOPSY TRAY MNS9106 ULTRASOUND BIOPSY TRAY MNS9170 CUTDOWN TRAY MNS9245 PACEMAKER TRAY MNS9335 IUD TRAY MNS9455 VAGINAL DELIVERY TRAY W/INSTRUMENTS MNS9480 VAGINAL DELIVERY TRAY MNS9480 VAGINAL DELIVERY TRAY MNS9625 TRACHEOSTOMY KIT MNS965 AMNIOCENTESIS TRAY MNS9710 IUD TRAY MNS9765 PORT INSERTION TRAY MNS9780 ARTHROGRAM TRAY MNS9820 OB PACK MNS9835 VAG DELIVERY TRAY MNS9835 VAG DELIVERY TRAY MNS9855 PACEMAKER INSTRUMENT TRAY MNS9870 DR. NELSON MOHS PACK MNS9870 DR. NELSON MOHS PACK MNS9935 CATH LAB INSTRUMENT KIT

    FDA Enforcement
    Class II ·Terminated·Centurion Medical Products Corporation·February 12, 2020