146 results
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39ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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DeRoyal KNEE ARTHROSCOPY PACK, REF 89-6192.04, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Manufacturer: DeRoyal Industries, Inc.
FDA Enforcement
Class II
·Terminated·DeRoyal Industries Inc·August 6, 2014
Kits and Trays containing alcohol swabstick/prep pad: GEO-MED BIOPSY TRAY, V A MED CTR MARTINSBURG, REF 89-7617.01 Rx Only, STERILE EO, Distributed by Geo-Med, LLC, 478 Altamonte Drive, Ste. 108, PMB 235, Altamonte Springs, FL 37201; DeRoyal (R) ST TPN/CVC DRG KIT W/VAD, REF 47-003, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) TPN/CVC Dressing Change Kit, REF 47-094.019, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ST TPN/CVC DRG CHG KIT, REF 47-276.13, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ST CEN LINE KIT, REF 47-324, Rx Only, STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA Made in the Dominican Republic; DeRoyal (R) ST PED TRAY, REF 47-327, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ST MAYO CLINIC PICC KIT, REF 47-483, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ST PICC DRG CHG KIT, REF 47-491.12, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ST IHC DRG CHG KIT, REF 47-600, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA, Made in the Dominican Republic; DeRoyal (R) PRESBYT PIC KIT-NICU, REF 47-626.10, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ST NEONATAL DRG CHG KIT, REF 47-670.05, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) BONE MARROW PREP TRAY, UNIV OF ROCHESTER, REF 47-743.01, Rx Only, STERILE EO, Manufactured by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) St. Central Line Kit, REF 47-777.02, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ARTERIAL LINE HYPER TRAY-25C, UNIV VIRGINIA CHARLOTTESVILLE, REF 50-3474.02, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) BONE MARROW BIOPSY, UNIVERSITY OF WASHINGTON, REF 89-3899.01, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) BIOPSY TRAY, PARKWAY RADIOLOGY, REF 89-6306.02, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ARTERIAL LINE TRAY, ERLANGER MEDICAL CENTER, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ST DRESSING CHANGE KIT, Rx Only, STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA Made in the Dominican Republic; DeRoyal (R) ST DIALYSIS KIT, Rx Only, STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ST TRN/CVC DRG KIT W/TRANS, Rx Only, STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) CVC Dressing Change Kit, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA
FDA Recall
Terminated
·Deroyal Industries, Inc. Lafollette·Product code LRP·February 7, 2011
Kits and Trays containing lubricant: GEO-MED BASIC CYSTO PACK, V A CENTRAL PLAINS HEALTH NET, REF 50-13272.05, Rx Only, STERILE EO, Distributed by Geo-Med, LLC, 478 Altamonte Drive, Ste. 108, PMB 235, Altamonte Springs, FL 37201; GEO-MED CYSTO PACK PGYBK, V A MED CTR COLUMBIA, Rx Only, STERILE EO, Distributed by Geo-Med, LLC, 478 Altamonte Drive, Ste. 108, PMB 235, Altamonte Springs, FL 37201; GEO-MED CYSTO HYDRO II PACK, VAMC-NORTHPORT, Rx Only, STERILE EO, Distributed by Geo-Med, LLC, 478 Altamonte Drive, Ste. 108, PMB 235, Altamonte Springs, FL 37201; GEO-MED GU TUR BASIN SET PGYBK, V A MED CTR BAY PINES - C, Rx Only, STERILE EO, Distributed by Geo-Med, LLC, 478 Altamonte Drive, Ste. 108, PMB 235, Altamonte Springs, FL 37201; GEO-MED CYSTO HYDRO II PACK, VA MEDICAL CENTER - BRONX, Rx Only, STERILE EO, Distributed by Geo-Med, LLC, 478 Altamonte Drive, Ste. 108, PMB 235, Altamonte Springs, FL 37201; GEO-MED ORTHO PACK A&B, VA MEDICAL CENTER - BRONX, Rx Only, STERILE EO, Distributed by Geo-Med, LLC, 478 Altamonte Drive, Ste. 108, PMB 235, Altamonte Springs, FL 37201; DeRoyal (R) CARDIOVASCULAR DRAPE, MERITCARE HOSPITAL, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) CYSTO PACK, ST. MARY'SMED CTR, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) MAJOR CYSTO TRAY, BRYAN LGH MED CENTER EAST, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) URETHRAGRAM TRAY 20/CS, NORTH MISSISSIPPI MED CTR, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) PELVIC EXAM TRAY, BAPTIST MEMORIAL OXFORD, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) TUR PACK PGYBK 5/CS, PHOEBE PUTNEY MEM HOSP, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) LABOR AND DELIVERY TRACECART (R), KEESLER MED CTR, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) PHASE ONE DELIVERY TRACECART, TALLAHASSEE MEM REGNL CTR-AMT, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) CYSTO PACK, HOLLAND COMMUNITY HOSPITAL, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) GU MINOR, MIDDLESEX MEMORIAL HOSP, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) CYSTO TRAY, ST ANTHONYS HOSPITAL, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) T V H TRAY, PHOEBE PUTNEY MEM HOSP, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) LTC/LAP TRAY, PHOEBE PUTNEY MEM HOSP, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) LAP GYN TRAY, COFFEE REGIONAL MED CTR, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) RADICAL PROST TRAY PGYBK, HAYS MEDICAL CENTER, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) D&C GYN PACK, HIGH POINTE SURG CTR, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) CRYO TRAY PGYBK, MIDTOWN SURG CTR, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) CYSTO TRAY, HOUSTON MEDICAL CTR, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) CYSTO TRAY, UNIV ARKANSAS MED LITTLE ROCK, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, In
FDA Recall
Terminated
·Deroyal Industries, Inc. Lafollette·Product code LRP·February 7, 2011
DeRoyal (R) Incision and Drainage Tray, RES 47-763.02, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA Lot Numbers: 20641391, 21092240, 21950988, 22594153, 22739623, 22773346, 23068497, 23098901, 23435082, 24203902, 24725655, 24781729, 24901874, 25403527 DeRoyal (R) Incision and Drainage Tray, RES 47-773, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA Lot Numbers: 20432290, 20605752, 20922248, 21092178, 22615161, 23231338, 23567595, 24526171, 24781745 DeRoyal (R) Incision and Drainage Tray, OCEAN SPRINGS HOSP, RES 50-12437.08, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA Lot Numbers: 22871229, 23187891, 23282362, 23335049, 23693022, 24004508, 24289321, 24599046, 24853850, 25159510, 25609040, 20675048, 20886013, 21316397, 21529982, 21861715, 22203984, 22412903, 22729708, 22799765 DeRoyal (R) Incision and Drainage Tray, ST JOSEPHS HOSPITAL, RES 89-6818.01, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA Lot Numbers: 23606275, 23941604, 24336115, 24867670, 25220026, 25324301, 25814617, 21364022, 21372541, 21420961, 21469650, 21527602, 21641296 DeRoyal (R) Universal Insertion Tray, RES 89-5649.01, ST FRANCIS MED CAPE GIRARDEAU, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA Lot Numbers: 22981727, 23234934, 21320071, 21374634, 21651531, 21817255, 22019861, 22187911, 22588503, 21651531 DeRoyal (R) St. Suture Removal Kit, RES 32-1695, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA, made in Dominican Republic Lot Numbers: 20170218, 21096486, 21114411, 21242931, 21331394, 21344427, 21381711, 23683529, 23767212, 23883758 DeRoyal (R) Stainless Suture Removal Set, RES 32-351, Rx Only, STERILE EO, Manufactured by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA, made in Dominican Republic Lot Numbers: 20188629, 20738627, 20838062, 21114437, 21410754, 21667171, 21790558, 22052557, 22389467, 22572739, 22865427, 23169950, 23452384, 23627906, 23883820, 24255913, 24408502, 24957430 DeRoyal (R) CRICOTHYREOTOMY AMBULANCE KIT, WISHARD MEMORIAL HOSPITAL, RES 89-6752.01, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA Lot Numbers: 20835339, 21511803, 23485821 DeRoyal (R) DR MATA'S PLASTIC PACK, OUR LADY OF LOURDES, RES 89-7212.01, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA Lot Numbers: 22408453, 22653627, 22718814, 22777961, 23218782, 23942181, 24285119, 24571254, 24597462, 25414921, 25527677, 25646027, 25683611, 25744313, 25744321 Custom Surgical kits.
FDA Recall
Terminated
·Deroyal Industries, Inc. Lafollette·Product code LRP·April 28, 2011
Circumcision trays and packs listed as follows: (1) DeRoyal (R) ST. Circumcision Tray, REF 50-5613, 1 Per Pack, Rx Only STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; Made in Dominican Republic Lot Numbers: 20854003, 22892644 (2) DeRoyal (R) ST. Circumcision PACK 1.3 CLAMP CLAMPMEMORIAL HEALTH, MEMORIAL HOSP TAL WEST, REF 89-5699, 1 Per Pack, Rx Only STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA Lot Number 20012949 Circumcision Clamp
FDA Recall
Terminated
·Deroyal Industries, Inc. Lafollette·Product code HFX·May 5, 2011
DeRoyal KNEE ARTHROSCOPY PACK, REF 89-6192.04, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Manufacturer: DeRoyal Industries, Inc.
FDA Recall
Terminated
·DeRoyal Industries Inc·Product code LRO·June 4, 2014
Custom anesthesia kits labeled as follows: (1) DeRoyal (R) Adult Exp Anesthesia Circuit, REF 86-001737, Rx Only, NON-STERILE, Manufactured by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; Lot Number 25660996 (2) DeRoyal (R) Adult Anesthesia Circuit, REF 86-001781, Rx Only, NON-STERILE, Manufactured by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; Lot Numbers: 25574115, 25624514, 25661260, 25702578, 25766272, 25835901, 25835910, 25873406, 25906061, 25960681 (3) DeRoyal (R) Latex Safe Anesthesia Kit, REF 86-001641, Rx Only, NON-STERILE, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA: Lot Numbers: 25573171, 25765667, 25834853, 25834861 (4) DeRoyal (R) Custom Anesthesia Kit, REF 86-001619, Rx Only, NON-STERILE, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA: Lot Number 25573155 (5) DeRoyal (R) Anesthesia Kit, REF 86-001669, Rx Only, NON-STERILE, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA: Lot Numbers: 25313484, 25702324, 25977977 Intended Use: Varies by kit; an anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece.
FDA Recall
Terminated
·Deroyal Industries, Inc. Lafollette·Product code OGD·August 23, 2011
Custom surgical kits: DeRoyal(R) TRAUMA CRANIOTOMY PACK, REF 89-7639.01, STERILE EO, Manufactured by: DeRoyal Industries, Inc., Powell, TN 37849 DeRoyal(R) TRAUMA CRANIOTOMY PACK PGYBK, REF 89-7639.01, STERILE EO, Manufactured by: DeRoyal Industries, Inc., Powell, TN 37849 DeRoyal(R) TRAUMA CRANIOTOMY PACK PGYBK, REF 89-7639.02, STERILE EO, Manufactured by: DeRoyal Industries, Inc., Powell, TN 37849 surgical kits
FDA Recall
Terminated
·Product code LRP·January 10, 2012
DeRoyal Cardiac Hypothermia Tray, REF 50-9422.07, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Made in Guatemala
FDA Enforcement
Class II
·Terminated·DeRoyal Industries Inc·August 6, 2014
DeRoyal (R) ST. Circumcision Clamp, REF 32-1622, 1 Per Pack, Rx Only STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA Circumcision Clamp
FDA Recall
Terminated
·Deroyal Industries, Inc. Lafollette·Product code HFX·May 5, 2011
DeRoyal (R) Surgical Eye Spears, REF 30-049, Sterile EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, MADE IN GUATEMALA cleaning of fluids from surgical site in or near the eye
FDA Enforcement
Class II
·Terminated·DeRoyal Industries Inc·November 20, 2013
DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Foot/Ankle Blanket NS, REF T656NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
FDA Enforcement
Class II
·Terminated·DeRoyal Industries Inc·February 5, 2014
DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blanket NS, REF T652NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
FDA Enforcement
Class II
·Terminated·DeRoyal Industries Inc·February 5, 2014
DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blnkt NS, REF T653NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
FDA Enforcement
Class II
·Terminated·DeRoyal Industries Inc·February 5, 2014
DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee Blanket w/ Straps NS, REF T654NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
FDA Enforcement
Class II
·Terminated·DeRoyal Industries Inc·February 5, 2014
DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Shoulder Blanket w/ Straps NS, REF T655NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
FDA Enforcement
Class II
·Terminated·DeRoyal Industries Inc·February 5, 2014
DeRoyal Cardiac Hypothermia Tray, REF 50-9422.07, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Made in Guatemala
FDA Recall
Terminated
·DeRoyal Industries Inc·Product code LRO·June 4, 2014
Aquarius (TM) TEMPERATURE THERAPY, REF T650, Rx Only, Manufactured for DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Made in China. Physical Therapy.
FDA Enforcement
Class II
·Terminated·DeRoyal Industries Inc·February 5, 2014
DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blnkt NS, REF T653NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
FDA Recall
Terminated
·DeRoyal Industries Inc·Product code ILO·September 17, 2013
DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blanket NS, REF T652NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
FDA Recall
Terminated
·DeRoyal Industries Inc·Product code ILO·September 17, 2013