299 results · 24ms · Sources: EU EUDAMED, US FDA

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Soft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090

FDA Recall
Terminated ·Signal Medical Corporation·Product code GFJ·February 20, 2017

smith&nephew PROFIX Mallet, 750 GRAMS, REF 71512452 - Product Usage: The PROFIX Mallet is a reusable surgical instrument used to tap instruments or implants during knee or hip surgery.

FDA Recall
Terminated ·Smith & Nephew, Inc.·Product code GFJ·November 11, 2019

PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to determine PD-L1 levels for determination of patient treatment options.

FDA Recall
Terminated ·Dako North America Inc.·Product code PLS·February 2, 2018

GE Centricity PACS RA1000 Workstation; for diagnostic image analysis. GE Healthcare Integrated IT Solutions, Barrington, IL 60010

FDA Recall
Terminated ·GE Healthcare Integrated IT Solutions·Product code LLZ·December 28, 2007

ACCESS TRAY/Product SKU's (Codes) ASK-03000-CHUQ, ASK-03000-CHUQ1, ASK-04001-GFH, ASK-04001-SUH and ASK-04001-UHC. Access tray for epidural anesthesia kit

FDA Recall
Terminated ·Arrow International Inc·Product code CAZ·October 29, 2010

Medline Custom procedural kits labeled as follows: a. GP-NEURO PACK, b. KIT NEUR FUS LUM POST, c. KIT PEDI VP SHUNT, d. KIT STC NEURO SPINE GENERIC, e. MAIN BASIC NEURO, f. MAJOR NEURO PK-LF, g. NEURO, h. NEURO CERVICAL PACK, i. NINOR NEURO PK-LF, j. VP SHUNT PACK Model/Catalog Number: Model Numbers: a.DYNJ0397191V, b. DYKMBNDL138, c. DYNJ907374, d. DYKMBNDL40A, e. DYNJ908260, f. DYNJ21243M, g. DYNJ904818D, DYNJ905194, DYNJ904040D, DYNJ904040F, DYNJ904818C, DYNJ905753A, h. DYNJ0101287I, i. DYNJ21244N, j. DYNJ46530J

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP SPT·Product code OJG·June 6, 2022

Helioseal F Sealant Refill 1 x 1.25 g, REF 558519AN, and Helioseal F Assortment (kit) 5 x 1.25 g, REF 558518AN. Dental sealant. -- ivoclar vivadent clinical --- Helioseal F Refill is provided in a syringe packed sealed foil bag. Helioseal F is a light-curing, white-shaded fissure sealant featuring fluoride release. Helioseal fissure sealants are suitable for the sealing of pits, fissures and foramina caeca.

FDA Recall
Terminated ·Ivoclar A. G. Fl-9494 Schaan Liechtenstein·Product code EBC·October 7, 2015

Drop Arm Versamode"

FDA Recall
Terminated ·Gf Health Products·Product code ILS·March 24, 2021

John Bunn 1392 Series Jackson Tracheostomy Stainless Steel Tube.

FDA Recall
Terminated ·Gf Health Products, Inc.·Product code BTO·September 14, 2009

Lumex, Patriot Full Electric Homecare Bed, & Patriot LX Full Electric Homecare Bed containing the Okin Dumat 3 Head/Foot Motors. Description Part Number Motor and Pendant Patriot Full Electric 120V 690-3001-943 / 690-7001-943 Boxed Full Electric 220V Motor 690-3220-943 Motor and Pendant Patriot LX Full Electric 120V 690-8004-912

FDA Recall
Terminated ·GF Health Products, Inc·Product code FNL·September 30, 2016

Sterile Procedural Trays, labeled as the following: a. GYN ABD CDS b. LAVH PROCEDURE c. TAH CDS d. CUH LITHOTOMY CDS e. LAVH CDS f. GROTH VAGINAL CDS g. MAJOR LITHOTOMY h. MAJOR VAGINAL HARPER PACK-LF i. VAG. HYST TRAY-LF j. VAGINAL HYSTERECTOMY PACK-LF k. HYSTERECTOMY PACK-LF l. HYSTERECTOMY PACK m. MAJOR ABD PROCEDURE PACK-LF n. GYN PACK o. BLADDER SLING PACK p. PERI/GYN PACK-RFD q. ROBOT HYSTERECTOMY r. VAG HYST s. GYN MAJOR PACK t. VAGINAL HYSTER PROCEDURE u. TLH PACK v. TLH PACK w. VAG HYST PACK x. LITHOTOMY-LF y. MAJOR LITHOTOMY z. LAVH aa. LAVH bb. D&C / GYN cc. LAPAROSCOPIC HYSTERECTOMY dd. FS LAP TUBAL LIGATION ee. LAVH ff. ABD HYST PACK-LF gg. VAG HYST PK-LF

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OJF·November 17, 2022

Zenith Slide W-I-D-E Long Term Care Bed, Model(s) APS98674, APS9867406, APS986741, APS986742, ZG58674, ZG78674, ZZ78674, ZZ98674, and ZZ98774. Designed for use within an institutional healthcare environment (i.e. assisted living, skilled nursing, transitional care, rehabilitation centers, etc.).

FDA Recall
Terminated ·GF Health Products, Inc./d.b.a.Basic American Metal Products·Product code FNL·July 21, 2014

LUMEX A Graham-Field Brand, Bed End Sert. Low/Full-electric, Plastic Panels, Item 690-7604-000 Manufactured for : GF Heath Products, Inc., Atlanta, Georgia 30360 Made in China. LUMEX A Graham-Field Brand, Bed End Sert. Low/Full-electric, Walnut Panels, Item 690-7004-000 Manufactured for : GF Heath Products, Inc., Atlanta, Georgia 30360 Made in China. Therapeutic bed intended for home use.

FDA Recall
Terminated ·GF Health Products, Inc./d.b.a.Basic American Metal Products·Product code LLI·April 17, 2012

Sterile Procedural Trays, labeled as the following: a. KNEE ARTHROSCOPY CDS-LF b. ARTHROSCOPY CDS c. ARTHROSCOPY LV - EDOC PACK-LF d. ARTHROSCOPY PACK-LF e. ARTHROSCOPY PACK f. ARTHRO PACK-LF g. ARTHROSCOPY PACK-LF h. ARTHROSCOPY PACK-LF i. ARTHROSCOPY KNEE TRAY-LF j. ARTHROSCOPY PACK-LF k. ARTHROSCOPY BASIN PACK-LF l. ARTHROTOMY PACK-LF m. ARTHROSCOPY PACK-LF n. ARTHROSCOPY PACK o. ARTHROSCOPY PACK p. ARTHROSCOPY PACK q. ARTHROSCOPY PACK - LF r. SC ARTHROSCOPY PACK s. ARTHROSCOPY PACK-LF t. ARTHROSCOPY PACK u. ARTHROSCOPY PACK v. ARTHROSCOPY PACK w. OSC ARTHROSCOPY PK-LF x. ARTHROSCOPY PACK y. ARTHROSCOPY PACK z. ARTHROSCOPY PACK aa. ARTHROSCOPY PACK bb. ARTHROSCOPY PACK cc. KNEE ARTHROSCOPY PACK dd. KNEE ARTHROSCOPY PACK ee. SHOULDER ARTHROSCOPY PACK ff. SHOULDER ARTHROSCOPY gg. ARTHROSCOPY PACK hh. ARTHROSCOPY PACK ii. ARTHROSCOPY PACK jj. ARTHROSCOPY PACK kk. ARTHROSCOPY PACK ll. ARTHROSCOPY PACK-LF mm. ARTHROSCOPY KNEE nn. ARTHROSCOPY PACK oo. HIP ARTHROSCOPY PACK pp. ARTHROSCOPY PACK qq. MG NS KNEE ARTHROSCOPY PACK rr. KNEE ARTHROSCOPY PACK ss. ARTHROSCOPY PACK tt. ARTHROSCOPY-LF uu. ARTHROSCOPY KIT vv. SHOULDER ARTHROSCOPY ww. KNEE ARTHROSCOPY xx. ARTHROSCOPY PACK

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OII·November 17, 2022

FlexTray Procedure Delivery System Endopath Bariatric Surgery Tray, Product #KNB21.

FDA Recall
Terminated ·Ethicon Endo-Surgery·Product code GCJ·November 25, 2003

Extron Electronics OEM, CAB, DVI-Male to DVI-Female Cable Assembly (14 inch.); Part #: 43-111-01 (Stryker Part #: 0100-224-131); Distributed by Stryker Communications, Flower Mound, TX 75028. (These cables are commonly used with the Switchpoint Infinity II)

FDA Recall
Terminated ·Stryker Communications·Product code GCJ·October 3, 2007

Weck Vista" Universal Laparoscopic Port, Size 5/10/12mmx125mm, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.

FDA Recall
Terminated ·Teleflex Medical·Product code GCJ·March 11, 2014

Composix" LP with Echo PS" 6x10 Reorder Number: 0144610 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

FDA Recall
Terminated ·Davol, Inc., Subs. C. R. Bard, Inc.·Product code GCJ·April 24, 2014

Applied Medical's LAP CHOLE KIT 7 GK; Model Number: GK107 The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.

FDA Recall
Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa·Product code GCJ·September 10, 2010

Applied Medical's LAP CHOLE ; Model Number: K2155 The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.

FDA Recall
Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa·Product code GCJ·September 10, 2010