BEUDAMED
    40 results · 14ms · 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 Status: Ongoing ×

    HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-32J

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·February 7, 2024

    HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-32J

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·February 7, 2024

    HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-28J

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·February 7, 2024

    EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Orthopedic implant component.

    FDA Enforcement
    Class II ·Ongoing·Encore Medical, LP·November 2, 2022

    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-22-XX, Novation GXL 10 deg Liner, G00, 22mm ID. Orthopedic hip implant component.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·July 28, 2021

    TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.213S

    FDA Enforcement
    Class II ·Ongoing·Synthes (USA) Products LLC·March 22, 2023

    TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures Part Number: 04.037.242S

    FDA Enforcement
    Class II ·Ongoing·Synthes (USA) Products LLC·March 22, 2023

    Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis

    FDA Enforcement
    Class II ·Ongoing·Coloplast Manufacturing US, LLC·April 19, 2023

    TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.212S

    FDA Enforcement
    Class II ·Ongoing·Synthes (USA) Products LLC·March 22, 2023

    Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis

    FDA Enforcement
    Class II ·Ongoing·Coloplast Manufacturing US, LLC·April 19, 2023

    Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis

    FDA Enforcement
    Class II ·Ongoing·Coloplast Manufacturing US, LLC·April 19, 2023

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH GXL 0 DEGREE LINER 28MM SZ E, REF 130-28-25 b. ACUMATCH GXL 0 DEGREE LINER 28MM SZ F, REF 130-28-26 c. ACUMATCH GXL 0 DEGREE LINER 28MM SZ G, REF 130-28-27 d. ACUMATCH GXL 0 DEGREE LINER 28MM SZ H, REF 130-28-28 e. ACUMATCH GXL 0 DEGREE LINER 28MM SZ J, REF 130-28-29 f. ACUMATCH GXL 0 DEGREE LINER 32MM SZ G, REF 130-32-27 g. ACUMATCH GXL 0 DEGREE LINER 32MM SZ H, REF 130-32-28 f. ACUMATCH GXL 0 DEGREE LINER 32MM SZ J, REF 130-32-29 g. ACUMATCH GXL 0 DEGREE LINER 36MM SZ H, REF 130-36-28 h. ACUMATCH GXL 0 DEGREE LINER 36MM SZ J, REF 130-36-29 i. ACUMATCH GXL 0 DEGREE LINER 36MM SZ K, REF 130-36-30 j. ACUMATCH GXL 15 DEG +5 LAT LINER 28MM SZ E, REF 138-28-25 k. ACUMATCH GXL 15 DEG +5 LAT LINER 28MM SZ F, REF 138-28-26 l. ACUMATCH GXL 15 DEG +5 LAT LINER 28MM SZ G, REF 138-28-27 m. ACUMATCH GXL 15 DEG +5 LAT LINER 28MM SZ H, REF 138-28-28 n. ACUMATCH GXL 15 DEG +5 LAT LINER 28MM SZ J, REF 138-28-29 o. ACUMATCH GXL 15 DEG +5 LAT LINER 36MM SZ H, REF 138-36-28 p. ACUMATCH GXL 15 DEG +5 LAT LINER 36MM SZ J, REF 138-36-29 q. ACUMATCH GXL 15 DEG +5 LAT LINER 36MM SZ K, REF 138-36-30 r. ACUMATCH GXL 15 DEG +5 LAT LINER SZG 38MM, REF 138-36-27 s. ACUMATCH GXL 15DEG LINER 28MM SZ D, REF 132-28-24 t. ACUMATCH GXL 15DEG LINER 28MM SZ E, REF 132-28-25 u. ACUMATCH GXL 15DEG LINER 28MM SZ F, REF 132-28-26 v. ACUMATCH GXL 15DEG LINER 28MM SZ G, REF 132-28-27 w. ACUMATCH GXL 15DEG LINER 28MM SZ H, REF 132-28-28 x. ACUMATCH GXL 15DEG LINER 28MM SZ J, REF 132-28-29 y. ACUMATCH GXL 15DEG LINER 28MM SZ K, REF 132-28-30 z. ACUMATCH GXL 15DEG LINER 32MM SZ G, REF 132-32-27 aa. ACUMATCH GXL 15DEG LINER 32MM SZ H, REF 132-32-28 bb. ACUMATCH GXL 15DEG LINER 32MM SZ J, REF 132-32-29 cc. ACUMATCH GXL 15DEG LINER 32MM SZ K, REF 132-32-30 dd.ACUMATCH GXL 15DEG LINER 36MM SZ H, REF 132-36-28 ee. ACUMATCH GXL 15DEG LINER 36MM SZ J, REF 132-36-29 ff. ACUMATCH GXL 15DEG LINER 36MM SZ K, REF 132-36-30 gg. ACUMATCH GXL EXT COV LINER 28MM SZ E, REF 134-28-25 hh. ACUMATCH GXL EXT COV LINER 28MM SZ F, REF 134-28-26 ii. ACUMATCH GXL EXT COV LINER 28MM SZ G, REF 134-28-27 jj. ACUMATCH GXL EXT COV LINER 28MM SZ H, REF 134-28-28 kk. ACUMATCH GXL EXT COV LINER 28MM SZ J, REF 134-28-29 ll. ACUMATCH GXL EXT COV LINER 28MM SZ K, REF 134-28-30 mm. MCS GXL LINER 5/15 DEG 4448X28, REF 104-28-43 nn. MCS GXL LINER 5/15 DEG 5052X28, REF 104-28-44 oo. MCS GXL LINER 5/15 DEG 5458X28, REF 104-28-45 pp. MCS GXL LINER 5/15 DEG 5458X32, REF 104-32-45 qq. MCS GXL LINER 5/15 DEG 6064X32, REF 104-32-46 rr. MCS GXL LINER 5/15 DEG 6064X36, REF 104-36-46 ss. MCS GXL LINER 5/15 DEG 6670X36, REF 104-36-47

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022

    Various reprocessed products: PROVISION, Reprocessed Smith and Nephew Arthroscopic Shavers, STERILE EO; PROVISION Reprocessed Depy Mitek Ablation Electrodes, VAPR COOLPULSE 90 deg; PROVISION Reprocessed Smith and Nephew Trocars/ Cannulas (Class I); PROVISION Reprocessed Conmed/ Linvatec Suture Retrievers/ Passers C6387 See updated product list attached for details.

    FDA Enforcement
    Class II ·Ongoing·ReNovo, Inc.·March 10, 2021

    Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Intelli-C X-ray system

    FDA Enforcement
    Class II ·Ongoing·NRT X-RAY A/S·May 15, 2024

    Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, part of the Noah Medical Galaxy System (GAL-001)

    FDA Enforcement
    Class II ·Ongoing·Noah Medical·December 18, 2024

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER, NEUTRAL, 28MM ID, GROUP 1 CUPS, REF 130-28-51 b. NOVATION GXL LINER, NEUTRAL, 32MM ID, GROUP 2 CUPS, REF 130-32-52 c. NOVATION GXL LINER, NEUTRAL, 36MM ID, GROUP 3 CUPS, REF 130-36-53 d. NOVATION GXL LINER, NEUTRAL, 36MM ID, GROUP 4 CUPS, REF 130-36-54 e. NOVATION GXL LINER, NEUTRAL, 36MM ID, GROUP 5 CUPS, REF 130-36-55 f. NOVATION GXL LINER, +5 LAT 32MM ID, GROUP 3 CUPS, REF 136-32-53 g. NOVATION GXL LINER, +5 LAT 32MM ID, GROUP 4 CUPS, REF 136-32-54 h. NOVATION GXL LINER, +5 LAT 32MM ID, GROUP 5 CUPS, REF 136-32-55 i. NOVATION GXL LINER, +5LAT, 28MM G1-48/50MM CUPS, REF 136-28-51 j. NOVATION GXL LINER, +5LAT, 32MM G1-48/50MM CUPS, REF 136-32-51 k. NOVATION GXL LINER, +5LAT, 32MM G2-52/54MM CUPS, REF 136-32-52 l. NOVATION GXL LINER, +5LAT, 36MM G2-52/54MM CUPS, REF 136-36-52 m. NOVATION GXL LINER, +5LAT, 36MM G3-56/58MM CUPS, REF 136-36-53 n. NOVATION GXL LINER, +5LAT, 36MM G4-60/62MM CUPS, REF 136-36-54 o. NOVATION GXL LINER, +5LAT, 36MM G5-64/66/68MM CUPS, REF 136-36-55 p. NOVATION GXL LINER, 10 DEG FACE, 32MM ID, GRP 1 CUP, REF 138-32-51 q. NOVATION GXL LINER, 10 DEG FACE, 32MM ID, GRP 3 CUP, REF 138-32-53 r. NOVATION GXL LINER, 10 DEG FACE, 36MM ID, GRP 2 CUP, REF 138-36-52 s. NOVATION GXL LINER, 10 DEG FACE, 36MM ID, GRP 3 CUP, REF 138-36-53 t. NOVATION GXL LINER, 10 DEG FACE, 36MM ID, GRP 4 CUP, REF 138-36-54 u. NOVATION GXL LINER, 10 DEG FACE, 36MM ID, GRP 5 CUP, REF 138-36-55 v. NOVATION GXL LINER, 10 DEG FACE, REPLACED BY 138-36-52, REF 138-32-52 w. NOVATION GXL LINER, LIPPED 32MM ID GROUP 2 CUPS, REF 132-32-52 x. NOVATION GXL LINER, LIPPED ANT, 32MM ID, GROUP 1 CUPS, REF 132-32-61 y. NOVATION GXL LINER, LIPPED ANT, 36MM ID, GROUP 2 CUPS, REF 132-36-62 z. NOVATION GXL LINER, LIPPED ANT, 36MM ID, GROUP 3 CUPS, REF 132-36-63 aa. NOVATION GXL LINER, LIPPED ANT, 36MM ID, GROUP 4 CUPS, REF 132-36-64 bb. NOVATION GXL LINER, LIPPED, 36MM ID, GROUP 3 CUPS, REF 132-36-53 cc. NOVATION GXL LINER, LIPPED, 28MM ID, GROUP 1 CUPS, REF 132-28-51 dd. NOVATION GXL LINER, LIPPED, 28MM ID, GROUP 2 CUPS, REF 132-28-52 ee. NOVATION GXL LINER, LIPPED, 32MM ID GROUP 4 CUPS, REF 132-32-54 ff. NOVATION GXL LINER, LIPPED, 32MM ID, GROUP 3 CUPS, REF 132-32-53 gg. NOVATION GXL LINER, LIPPED, 32MM ID, GROUP 5 CUPS, REF 132-32-55 hh. NOVATION GXL LINER, LIPPED, 36MM ID GROUP 4 CUPS, REF 132-36-54 ii. NOVATION GXL LINER, LIPPED, 36MM ID, GROUP 5 CUPS, REF 132-36-55 jj. NOVATION GXL LINER, NEUTRAL, 28MM ID, GROUP 2 CUPS, REF 130-28-52 kk. NOVATION GXL LINER, NEUTRAL, 32MM ID, GROUP 3 CUPS, REF 130-32-53 ll. NOVATION GXL LINER, NEUTRAL, 32MM ID, GROUP 4 CUPS, REF 130-32-54 mm. NOVATION GXL LINER, NEUTRAL, 32MM ID, GROUP 5 CUPS, REF 130-32-55

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51 b. NOVATION GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS, REF 130-36-52 c. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS, REF 130-40-53 d. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 4 CUPS, REF 130-40-54 e. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 5 CUPS, REF 130-40-55 f. NOVATION GXL LINER LIPPED 32MM ID, GROUP 1 CUPS, REF 132-32-51 g. NOVATION GXL LINER LIPPED 36MM ID GROUP 2, REF 132-36-52 h. NOVATION GXL LINER LIPPED 40MM ID, GROUP 3 CUPS, REF 132-40-53 i. NOVATION GXL LINER LIPPED 40MM ID, GROUP 4 CUPS, REF 132-40-54 j. NOVATION GXL LINER LIPPED 40MM ID, GROUP 5 CUPS, REF 132-40-55 k. NOVATION GXL LINER +5 LAT 40MM GROUP 3 CUPS, REF 136-40-53 l. NOVATION GXL LINER +5 LAT 40MM ID GROUP 4 CUPS, REF 136-40-54 m. NOVATION GXL LINER +5 LAT 40MM ID GROUP 5 CUPS, REF 136-40-55 n. NOVATION GXL LINER 10 DEG FACE 40MM ID, GRP 3 CUP, REF 138-40-53 o. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 4 CUP, REF 138-40-54 p. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 5 CUP, REF 138-40-55

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH 0 DEGREE LINER 28MM 46MM, REF 130-28-05; b. ACUMATCH 0 DEGREE LINER 28MM 48MM, REF 130-28-06; c. ACUMATCH 0 DEGREE LINER 28MM 50/52MM, REF 130-28-07; d. ACUMATCH 0 DEGREE LINER 28MM 54/56MM, REF 130-28-08; e. ACUMATCH 0 DEGREE LINER 28MM 58/64MM, REF 130-28-09; f. ACUMATCH 15 DEGREE LINER 22MM SZ D, REF 132-22-04; g. ACUMATCH 15 DEGREE LINER 22MM SZ E, REF 132-22-05; h. ACUMATCH 15 DEGREE LINER 22MM SZ F, REF 132-22-06; i. ACUMATCH 15 DEGREE LINER 22MM SZ G, REF 132-22-07; j. ACUMATCH 15 DEGREE LINER 22MM SZ H, REF 132-22-08; k. ACUMATCH 15 DEGREE LINER 28MM SZ E, REF 132-28-05; l. ACUMATCH 15 DEGREE LINER 28MM SZ F, REF 132-28-06; m. ACUMATCH 15 DEGREE LINER 28MM SZ G, REF 132-28-07; n. ACUMATCH 15 DEGREE LINER 28MM SZ H, REF 132-28-08; o. ACUMATCH 15 DEGREE LINER 28MM SZ J, REF 132-28-09; p. ACUMATCH 15 DEGREE LINER 28MM SZ K, REF 132-28-10; q. ACUMATCH 15 DEGREE LINER 32MM SZ G, REF 132-32-07; r. ACUMATCH 15 DEGREE LINER 32MM SZ H, REF 132-32-08; s. ACUMATCH 15 DEGREE LINER 32MM SZ J, REF 132-32-09; t. ACUMATCH 15 DEGREE LINER 32MM SZ K, REF 132-32-10; u. ACUMATCH EXT COV LINER 28MM 46MM, REF 134-28-05; v. ACUMATCH EXT COV LINER 28MM 48MM, REF 134-28-06; w. ACUMATCH EXT COV LINER 28MM 50/52MM, REF 134-28-07; x. ACUMATCH EXT COV LINER 28MM 54/56MM, REF 134-28-08; y. ACUMATCH EXT COV LINER 28MM 58/64MM, REF 134-28-09; z. ACUMATCH EXT COV LINER 28MM 66/70MM, REF 134-28-10; aa. ACUMATCH LAT LINER 28MM 46MM, REF 138-28-05; bb. ACUMATCH LAT LINER 28MM 48MM, REF 138-28-06; cc. ACUMATCH LAT LINER 28MM 50/52MM, REF 138-28-07; dd. ACUMATCH LAT LINER 28MM 54/56MM, REF 138-28-08; ee. ACUMATCH LAT LINER 28MM 58/64MM, REF 138-28-09; ff. ACUMATCH 15 DEG LINER, SZ F, 28MM ID, REF CSK-1663; gg. ACUMATCH 15 DEG LINER, SZ G, 28MM ID, REF CSK-1664; hh. ACUMATCH 15 DEG LINER, SZ H, 28MM ID, REF CSK-1665

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022

    Medline Kits, trays, and packs labeled as follows: a) 709E RECOVERY PACK A,B,C II SS, REF DYNJ55960G; b) ABDOMEN PACK, REF DYNJ53643C; c) BAG TRUNK STOCK KIT, REF DYKM1880; d) BEDSIDE BRONCH PACK, REF DYKE1601; e) BIOPSY TRAY, REF DYNDH1242; f) BRONCH KIT, REF DYKE1840; g) BRONCHOSCOPY PACK, REF DYNJ37775F; h) BRONCHOSCOPY TRAY, REF DYNDL1350A; i) BRONCHOSCOPY TRAY, REF DYNDL1350AH; j) CAP CHANGE LARGE KIT, REF DYNDA2277A; k) CAP CHANGE LARGE KIT, REF DYNDA2277B; l) DAILY VAD DRIVELINE KIT, REF DYNDC3006; m) DAILY VENT KIT, REF DYNDJ1076; n) DIALYSIS OFF KIT, REF DT21230A; o) DIALYSIS OFF KIT, REF DT20350B; p) DIALYSIS ON KIT, REF DT20355B; q) DOUBLE HUB/CAP CHANGE KIT, REF DYNDC2843; r) DR D CUSTOM PACK, REF DYNJ68068A; s) DR D CUSTOM PACK, REF DYNJ68068B; t) DUODENUM CULTURING PACK, REF DYNJ51294; u) EGD SOUTHEASTERN REG KIT, REF DYKE1830; v) EMERGENCY UMBILICAL INSERTION, REF UVT1165; w) ENDO KIT, REF DYKE1069B; x) ENDO KIT, REF DYKE1475B; y) ERCP ENDO KIT, REF P604360B; z) ERCP SOUTHEASTERN REG KIT, REF DYKM2127; aa) FACIAL PLASTY PACK, REF DYNJ55335D; bb) FIRST YEAR KIT LF, REF EDUC1037; cc) FOLEY BULB INDUCTION KIT, REF MNS13545; dd) G BUNDLE CDS, REF CDS982759; ee) GBMC ULTRASOUND GUIDED PIV KIT, REF DYNDV2330B; ff) GBMC ULTRASOUND GUIDED PIV KIT, REF DYNDV2330C; gg) GENERAL/HERNIA PACK, REF DYNJ38541B; hh) GI BRONCHOSCOPY KIT, REF DYKE1254C; ii) HH CAR STOCK IN BIN, REF DYKM1883; jj) IMMERSION 4, REF EDUC05059A; kk) KIT LINE INSERTION, REF CVI4730; ll) KIT, PEG, SOUTHEASTERN REG, REF DYKM2128; mm) LINE INSERT PACK, REF PHS422216004C; nn) MANUAL BLADDER IRRIGATION KIT, REF UROT1051; oo) MANUAL BLADDER IRRIGATION KIT1, REF UROT1051A; pp) MANUAL BLADDER IRRIGATION KIT1, REF UROT1051AH; qq) MOHS KIT, REF DYNDA2072A; rr) MULTI LUMEN CAP CHANGE, REF DYNDA2390A; ss) N HOME CARE WOUND KIT, REF DYK1188079W; tt) NURSE KIT NO LOGO-LF, REF EDUC05036; uu) NURSE TOTE, REF DYKM1872A; vv) NURSING SKILLS, REF EDUC05015A; ww) PICC, REF CDS980470D; xx) PRE OP KIT, REF DYKS1262A; yy) PULMONARY SETUP KIT, REF DYNDA2648; zz) PULMONARY SETUP KIT, REF DYNDA2648H; aaa) REDDY JOINT BATH, REF MMJB001; bbb) REDDY JOINT BATH, REF MMJB001A; ccc) RNSG 1441, REF EDUC1029; ddd) RNSG 1441, REF EDUC1029H; eee) RNSG 2201, REF EDUC1034; fff) RNSG 2201, REF EDUC1034H; ggg) SENSITIVE SKIN WEEKLY VAD, REF DYNDC3185; hhh) SHEATH REMOVAL TRAY, REF DYNDC1311C; iii) SHORT TERM KIT, REF DYNDC3092; jjj) SINGLE HUB/CAP CHANGE KIT, REF DYNDC2841; kkk) STERILE CAP CHANGE, REF DYNDA2387A; lll) STERILE PREP KIT, REF DYNDA1359; mmm) STERILE PREP KIT, REF DYNDA1359A; nnn) STRL EK SINGLE PACK, REF DYNDA1360B; ooo) SUB PORT ACCESS TRAY, REF DYNDC2768A; ppp) SUPRA PUBIC IRRIGATION TRAY ST, REF DYNDT1019; qqq) SURGICAL PREP KIT, REF DYNJ46340B; rrr) SUTURE KIT, REF M101494; sss) SUTURE TRAY, REF DYNDS1085A; ttt) TRUNK KIT, REF DYKTRUNK1; uuu) TRUNK KIT 1EA, REF DYKM2013; vvv) UMBILICAL VESSEL INSERTION, REF DYNDA3011; www) URINALYSIS KIT, REF DYKM1251; xxx) VAD ACCESS CHANGE KIT, REF DYNDC2882B; yyy) VAD DRESSING KIT A, REF DYNDA2164; zzz) CENTRAL BLOOD CULTURE KIT, REF DYNDH1342B; aaaa) CVC DRESSING CHANGE KIT, REF EBSI1552; bbbb) PORT ACCESS POWER LOC KIT, REF DYNDC1712B; cccc) PORT ACCESS TRAY, REF DYNDC1128B;

    FDA Enforcement
    Class I ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·March 6, 2024

    Various Alcon Custom Paks Surgical Procedure Pack containing Oasis 27Ga Chang Hydrodissection Cannulas. These Custom Paks are surgical procedure packs used by ophthalmic surgeons in a variety of ophthalmic surgeries. The Custom Pak is a collection of various ophthalmic surgical instruments and necessary materials. Below are the various Alcon Customer Paks and Pak REF Numbers: 0515-66 ELMENDORF AFB CATARACT 3RD MED CTR 0752-74 CATARACT V A MED CTR 1119-82 DR DAVID B LEACH PALOUSE SURGERY CENTER 11401-13 CATARACT SUTTER SOLANO MED CTR 11910-32 DAVISON-SAGGAU CATARACT WOLFE EYE SURGER 11912-26 30 DEG CATARACT BASE PACK WOLFE EYE SUR 11913-23 JOHNSON CATARACT WOLFE EYE SURGERY CENTE 12185-14 CATARACT LASERVUE EYE CENTER 12213-12 CATARACT TULSA SPINE AND SPECIALTY 12213-13 CATARACT TULSA SPINE AND SPECIALTY 12213-15 CATARACT TULSA SPINE AND SPECIALTY 12213-16 CATARACT TULSA SPINE AND SPECIALTY 12643-06 CATARACT PACK OCHSNER BAPTIST MED CTR 12931-17 JOHNSON CATARACT GREATER COMMUNITY HOSP 12942-18 CONRAD PHYSICIANS MEDICAL CENTER 12942-19 CONRAD PHYSICIANS MEDICAL CENTER 13567-10 OPHTHALMIC PHYSICIANS SURG CTR 13948-15 DR RHEE PACK MARSHALLTOWN MED/SURG CNT 13970-11 CATARACT GWINNETT CTR OUTPT SURG 13970-12 CATARACT GWINNETT CTR OUTPT SURG 14389-08 INFINITI STAMFORD SURGICAL CENTER 14408-12 E-Z PACK QUEEN OF THE VALLEY 14408-13 E-Z PACK QUEEN OF THE VALLEY 14533-18 OPHTHALMIC UOFL HOSPITAL 15209-05 CATARACT NORTH ATLANTA EYE SURGERY CTR 15354-16 DR RAUEN WOLFE EYE SURGERY CENTER LLC 15435-13 EPS 2.2 PACK IOWA CITY AMBULATORY SURGER 15502-10 DR NEWCOMB LEXINGTON CLINIC 15639-12 DR RAUEN LUCAS COUNTY HEALTH CTR 15678-13 DR RAUEN CLARKE COUNTY HOSPITAL 15965-12 DR LEVAR CHRISTUS SANTA ROSA ASC 16001-12 DR YONKER/BESCAK CESC 16001-13 DR YONKER/BESCAK CESC 16013-12 DR MCDONALD NORTH FL SURG PAVILION 16086-07 DR DAVID B LEACH PULLMAN MEMORIAL HOSPIT 16177-08 OPHTHALMIC DENVER EYE SURG CTR 16204-13 CATARACT V A HOSPITAL 16450-10 DR GROSS/GUSSLER KINGS DAUGHTERS HOSPITA 16452-06 RAECKER PACK GREATER COMMUNITY HOSP 16633-08 CATARACT DUOVISC RETINA SPECIALISTS NJ 16644-08 DR BALES HOSPITAL PACK NATIVE INVESTMENT 16644-09 DR BALES HOSPITAL PACK NATIVE INVESTMENT 16798-08 CATARACT HAUSER ROSS EYE INSTITUTE 16820-06 PHACO LONE PEAK SURGERY CENTER 17029-09 DR ICON CATARACT DAY SURGERY OF GRAND JU 17201-18 SILVERA VALLEY SURGERY CENTER 17340-08 EPS 2.2 PACK WASHINGTON COUNTY HOSP 17354-07 EPS 2.2 PACK HENRY COUNTY HEALTH CTR 17361-08 MICRO PAK CARLE FOUNDATION HOSP 17382-05 CATARACT BILLINGS VA MEDICAL CENTE 17382-07 CATARACT BILLINGS VA MEDICAL CENTE 17507-02 DR CAMPAGNA NORTH CENTRAL METH ASC 17520-05 DR GROSS CHARLESTON SURGERY CTR 17526-09 CPK0926-CROSBY-DONG-GADLIN-JAC VANTAGE O 17529-09 CPK0927 AESC VANTAGE OUTSOURCING 17541-07 HAIDER DUPONT SURG CTR 17541-08 HAIDER DUPONT SURG CTR 17617-05 DR CHUNG CATARACT PACK ST HELENA HOSPITA 17651-06 DMEK-DSEK-CAT CENTER FOR ADVANCED SURGER 17653-06 DR HUNT CHARLESTON AREA MED CTR 17671-06 CATARACT EDMONDS CENTER FOR OUTPAT 17671-07 CATARACT EDMONDS CENTER FOR OUTPAT 17740-06 DR ESPANDAR ARMSTRONG CO MEM HOSP 17740-07 DR ESPANDAR ARMSTRONG CO MEM HOSP 17740-08 DR ESPANDAR ARMSTRONG CO MEM HOSP 17773-09 DR ESPANDAR JAMESON MEMORIAL HOSPITAL 17930-08 CATARACT PACK NORTHERN PLAINS SURG CTR 17966-06 TURNER CATARACT WOLFE EYE SURGERY CENTER 17987-05 OPHTHALMIC SEATTLE SURGERY CENTER 18069-04 DR WENTWORTH CATARACT GREENVIEW SURGERY 18123-05 CATARACT BOWERS INNOVATIVE EYE SURGERY C 18208-09 CATARACT SUTTER FAIRFIELD SURG CTR 18382-04 DR GEORGE ZAMBELLI BEAVER VALLEY ASC 18382-06 DR GEORGE ZAMBELLI BEAVER VALLEY ASC 18384-04 DR BURKS SPRINGHILL SURGERY CENTER 18401-04 MCGRAW SIGHTPATH MEDICAL 18406-03 DR KUCHINKA HAYWARD AREA HOSP 18427-07 CATARACT V A HOSPITAL 18427-08 CATARACT V A HOSPITAL 18431-06 VISION EYE SC VISION EYE SURGERY CENTER 18445-03 K LEE/LIN CALIFORNIA PACIFIC MED CT 18550-04 DR HU TORRES CAT & LSR CNTRL 18555-04 DR WU - CENTURION CAT & LSR CNTRL 18636-10 CATARACT BONNER GENERAL HOSPITAL

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LLC·May 1, 2024