33 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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First Aid Kits containing acetaminophen under brand names Equate (Walmart), Meijer, and Care Science (Amazon)
FDA Enforcement
Class II
·Terminated·ASO LLC·May 11, 2022
NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # Part Name 20-0035 NeuRx DPS System Kit 20-0036 NeuRx Diaphragm Pacing System, Patient Kit, SCI 20-0028 NeuRx DPS Surgical Kit, HDE 20-0040 NeuRx Diaphragm Pacing System Spare Sterile Components 21-0001-99 Mapping Probe 21-0004-99 Indifferent Electrode 21-0007-99 Lead Tunneler Set 21-0009-99 Blue Cable Set 21-0010-99 Transducer Tubing 21-0017-99 PermaLoc Electrode 21-0023-99 Green Cable 21-0024-99 Orange Cable 21-0025-99 Yellow Cable 21-0026-99 White Cable 77-0050 Surgeon Instruction Manual 20-0045 NeuRx DPS System Kit, ALS HDE 20-0046 NeuRx Diaphragm Pacing System, Patient Kit, ALS Marketed under HDE H070003 as well as H100006
FDA Enforcement
Class III
·Terminated·Synapse Biomedical Inc·July 27, 2022
DONJOY REF:11-0447-9-ULTRASLING PRO, UNIVERSAL, Rx ONLY, UDI:(01)00190446673552 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
FDA Enforcement
Class II
·Terminated·DJ Orthopedics de Mexico S.A. de C.V.·May 5, 2021
Orthofix Power Drill Torque Limiter, Sterile, Rx Only, Single Use; Sold individually and in the Galaxy UNYCO Diaphyseal Tibia Sterile Kit, Galaxy UNYCO Mini Kit Instruments Sterile, Galaxy UNYCO Diaphyseal Femur Box, Galaxy UNYCO Knee Bridging Box, Galaxy UNYCO Ankle Bridging Box - Unilateral Frame, Galaxy UNYCO Ankle Bridging Box - Delta Frame, and Galaxy UNYCO Diaphyseal Tibia Box. Intended to be used for temporary bone stabilization in trauma and orthopedic procedures of the lower limb prior to definitive treatment.
FDA Enforcement
Class II
·Terminated·Orthofix Srl·January 3, 2018
R82 by ETAC Push Brace for High-Low
FDA Enforcement
Class II
·Terminated·R82 A/S·February 16, 2022
Kit: Midline Insertion DA. MAI Kit Part Number: 77981B
FDA Enforcement
Class I
·Terminated·Medical Action Industries, Inc. 306·May 19, 2021
DONJOY REF:11-0471-9 ULTRASLING PRO ER/IR 15, UNIVERSAL, Rx ONLY, UDI: (01) 00190446683667 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
FDA Enforcement
Class II
·Terminated·DJ Orthopedics de Mexico S.A. de C.V.·May 5, 2021
Sterile Custom Packs to be used in surgical procedures.
FDA Enforcement
Class II
·Terminated·American Contract Systems·June 10, 2020
In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery.
FDA Recall
Terminated
·In2Bones, SAS 28 Chemin du petit Bois Ecully France·Product code GFF·February 9, 2021
Torosa Saline-Filled Testicular Prosthesis (Size Small)
FDA Recall
Terminated
·Coloplast Manufacturing US, LLC·Product code FHW·November 9, 2021
Ad-Tech Lightweight CABRIO Cable - Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators.
FDA Recall
Terminated
·Ad-Tech Medical Instrument Corporation·Product code IKD·August 9, 2021
Ad-Tech Lightweight TECH ATTACH Cable - Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators.
FDA Recall
Terminated
·Ad-Tech Medical Instrument Corporation·Product code IKD·August 9, 2021
Ad-Tech TECH ATTACH Cable- Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators.
FDA Recall
Terminated
·Ad-Tech Medical Instrument Corporation·Product code IKD·August 9, 2021
ACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION, CONTENTS: 6 x 6.0 mL EXTRACTION SOLN, IVD, Rx Only, UDI: (01)15099590743017
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code QKP·July 1, 2021
Access SARS-CoV-2 Antigen Calibrators, Catalog, REF: C68669, Contents: 1x2.5 mL C0, 1x2.5mL C1, 1x CAL CARD, UDI: (01)15099590742720;
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code QKP·July 1, 2021
ACCESS SARS-CoV-2 Antigen , REF: C68668, IVD, Rx only, UDI: (01) 15099590742713;
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code QKP·July 1, 2021
FISTULA ON-OFF KIT. Medical convenience kit, Avid Medical Part Number: MMTN020.
FDA Recall
Terminated
·Avid Medical, Inc.·Product code LRO·April 9, 2021
FISTULA (ON/OFF) ALL IN ONE BAG. Medical convenience kit, Avid Medical Part Number: VAMK024-03
FDA Recall
Terminated
·Avid Medical, Inc.·Product code OEZ·April 9, 2021
DIALYSIS ACCESS Medical convenience kit, Avid Medical Part Number: VMED004-03.
FDA Recall
Terminated
·Avid Medical, Inc.·Product code LRO·April 9, 2021
ACCESS SARS-CoV-2 ANTIGEN QC, REF: C68670, CONTENTS: 3 X 6.0 mL QC1, 3 x 6.0 mL QC2, 1 QC VALUE CARD, IVD, Rx Only, UDI: (01)15099590742737;
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code QKP·July 1, 2021