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19ms
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Sources: EU EUDAMED, US FDA
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Wet PVP-I Vaginal Preoperative Skin Prep Tray containing 1 - 4 oz. bottle Povidone Iodine Cleansing Solution (Scrub) USP 7.5% and 1 - 4 oz. bottle Povidone Iodine Topical Solution (Paint) USP 10% with Powder-Free Esteem Gloves; 10 trays per case; a sterile, latex-free, single use only tray, solution not exposed to sterilant; U.S. components packaged in Mexico except as indicated: Gloves and Cotton-Tipped Applicators made in China, Sponge Stick made in Mexico; CareFusion, McGaw Park, IL 60085 USA; tray catalog number 4469A The Povidone Iodine patient prep trays are used where chlorhexidine gluconate (CHG) products aren't appropriate or indicated for patient preoperative prep (traditional two-step scrub and paint using cleansing solution and topical solution) on intact skin and mucous membranes, and for washing lacerations and abrasions.
FDA Recall
Terminated
·Product code HGD·February 7, 2012
SEDASYS Computer-Assisted Personalized Sedation System, SEDPRU01. An integrated physiological monitoring and drug delivery system intended to provide physician-led teams with a means of administering 1% propofol (10 mg/mL) injectable emulsion to sedate patients > 18 (ASA I-II) undergoing esophagogastroduodenoscopy (EGD) and colonoscopy procedures. Intended to provide physician-led teams with a means of administering 1% propofol (10 mg/mL) injectable emulsion to sedate patients > 18 (ASA I-II) undergoing esophagogastroduodenoscopy (EGD) and colonoscopy procedures.
FDA Enforcement
Class I
·Terminated·Ethicon Endo-Surgery Inc·September 2, 2015
SEDASYS Computer-Assisted Personalized Sedation System, SEDPRU01. An integrated physiological monitoring and drug delivery system intended to provide physician-led teams with a means of administering 1% propofol (10 mg/mL) injectable emulsion to sedate patients > 18 (ASA I-II) undergoing esophagogastroduodenoscopy (EGD) and colonoscopy procedures. Intended to provide physician-led teams with a means of administering 1% propofol (10 mg/mL) injectable emulsion to sedate patients > 18 (ASA I-II) undergoing esophagogastroduodenoscopy (EGD) and colonoscopy procedures.
FDA Recall
Terminated
·Ethicon Endo-Surgery Inc·Product code PDR·May 13, 2015
TiLite ZR and ZRA Series 2 are mechanical wheelchairs. Devices are sold under brand name TiLite. The TiLite ZR had a model catalog number of Z2FS1. The TiLite ZRA has a model catalog number of Z2FS2. Provide mobility for physically impaired individuals.
FDA Recall
Terminated
·TiSport, Llc·Product code IOR·July 5, 2011
Access Immunoassay Systems Thyroglobulin, Part Number: 33860 This device is intended to aid in monitoring for the presence of local and metastatic thyroid tissue in patients who have had thyroid gland ablation (using thyroid surgery with or without radioactivity) and who lack serum thyroglobulin antibodies.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code MSW·October 18, 2010
Cranial Access (CRAK) Kits, Product / Catalogue No.s: INSHITH, INSHITHND, INSHITHRZN The kits allow for access to the subarachnoid space or the lateral ventricles of the brain. The kits are intended to be used with an external drainage and monitoring system in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF, and to monitor ICP.
FDA Recall
Terminated
·Integra LifeSciences Corp. d.b.a. Integra Pain Management·Product code HGB·September 4, 2013
Stryker brand Firstcare Ultra Maternity bed and Stryker brand Adel Maternity bed, 220 volt, model 5012, with night light.
FDA Recall
Terminated
·Stryker Medical·Product code HDD·January 26, 2004
Stryker brand Firstcare Ultra Maternity bed, model 5010, with night light.
FDA Recall
Terminated
·Stryker Medical·Product code HDD·January 26, 2004
AVE 2 Birthing Bed
FDA Recall
Terminated
·Linet Spol. S.r.o. Zelevcice 5 Slany Czech Republic·Product code HDD·January 7, 2019
Hill-Rom Affinity Four Birthing Bed, Hill-Rom Company, Inc., Batesville, Indiana; Model P3700B. Intended to be used as birthing beds for momen of child bearing age in an labor, delivery, recovery or postpartum setting in acute care.
FDA Recall
Terminated
·Hill-Rom, Inc.·Product code HDD·November 16, 2009
Richard Wolf Hulka Clip; for single patient use only; a sterile tubal occluding device; 2 clips per procedure tray/pouch, 10 pouches per shipping carton; Richard Wolf Medical Instruments Corp., Vernon Hills, IL 60061; item 4986.90. Indicated for use for female sterilization (permanent contraception) by occluding the fallopian tubes
FDA Recall
Terminated
·Richard Wolf Medical Instruments Corp.·Product code HGB·October 16, 2009
Stryker brand Birthing Bed; Model 4701.
FDA Recall
Terminated
·Stryker Medical·Product code HDD·March 31, 2005
Hill-Rom Affinity 4 Birthing Bed; Model P3700B, Hill-Rom, Inc., Batesville, IN 47006
FDA Recall
Terminated
·Hill-Rom, Inc.·Product code HDD·September 6, 2007
Stryker brand Adel maternity bed, model 4700, with night light.
FDA Recall
Terminated
·Stryker Medical·Product code HDD·January 26, 2004
CENTRAL LINE FULL BODY DRAPE CUSTOMED CONTENTS: (1) WRAPPER 30" X 30" (2) MASK SURGICAL W/ VISOR ANTI-FOG 160mm Hg (2) CAP NURSE 21" GREEN BOUFFANT (2) TOWELS ABSORBENT 15" X 20" (2) GOWN LARGE STANDARD SMS VELCRO/NECK (1) DRAPE SHEET 41" X 58" SMS (1) DRAPE BRACHIAL ANGlO 44" X 31" REINFORCED 3" ADHESIVE CIRCULAR FENESTRATION Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
G3 Opticage Expandable Interbody Fusion Device, Model No. 9180-00, 9180-01, 9180-06, 9180-07, 9180-17, 9101-00, 9101-06 The Opticage Expandable Interbody Fusion Device is a posterior lumbar intervertebral body fusion device and is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Opticage Interbody Fusion Device can be implanted via posterior, transforaminal or lateral approach. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Candidates for surgery should be skeletally mature and have had six months of conservative treatment. These patients may have had primary or secondary surgery, but no previous fusion at the involved levels. The device is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine (i.e. facet screw fixation systems, facet compression devices and posterior pedicle screw and rod systems).
FDA Enforcement
Class II
·Terminated·Interventional Spine Inc·January 11, 2017
MANOS EX (CAT#TY-12-101) Product Usage: Carpal Tunnel Release: as a tool for tissue release of the transverse carpal ligament in patients with Carpal Tunnel Syndrome who fail conservative therapy. Plantar Fasciotomy: as a tool for tissue recession in patients with plantar fasciitis who fail conservative therapy.
FDA Enforcement
Class II
·Terminated·Thayer Intellectual Property, Inc.·December 14, 2016
Vereos PET/CT Model # 882446, computed tomography x-ray system
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·August 14, 2019
IQon Spectral CT Model # 728332, computed tomography x-ray system
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·August 14, 2019
Ingenuity TF PET/CT Model # 882456, computed tomography x-ray system
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·August 14, 2019