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Sources: EU EUDAMED, US FDA
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Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-BW1; (2) Arrow Arterial Access Tray with 0.021" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-CK; (3) Arrow Arterial Access Kit, .025 inch dia. spring-wire guide, REF ASK-04001-VAMC1; (4) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-BHS; (5) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .025 inch dia. spring-wire guide, REF ASK-04020-BID; (6) Arrow Arterial Line Kit, 20 Ga., 12 cm. catheter length, .025 inch dia. spring-wire guide, REF ASK-04020-HMC; (7) Arrow Arterial Catheterization Kit, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-HOA; (8) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm. catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-KSD; (9) Arrow Arterial Catheterization Kit, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-LOL; (10) Arrow Radial Catheterization, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-MHS; (11) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, 018 inch dia. spring-wire guide, REF ASK-04020-MIB3; (12) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 dia. spring- wire guide, REF ASK-04020-PRH; (13) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 dia. spring-wire guide, REF ASK-04020-UOIL; (14) Arrow QuickFlash Radial Artery Catheterization Kit, 20 Ga., 3.81 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04220-KSP; and (15) Arrow Arterial Catheterization Kit, 20 Ga. 4.45/12 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04500-HFH4.
FDA Recall
Open, Classified
·ARROW INTERNATIONAL Inc.·Product code DQX·July 26, 2024
Portable X-ray system
FDA Recall
Open, Classified
·DIGIMED CO., LTD
401, 402, 406~411-ho, A-dong 101, Gasan digital 2-ro, Geumcheon-Gu
Seoul Korea (the Republic of)·Product code EHD·June 19, 2025
AOA Mini RPE Screw Assembly , a component of Herbst, MARA and Fixed Metal devices. Product Usage: AOA Mini RPE Screw Assembly is a component of Herbst, MARA and Fixed Metal devices; removable functional appliances that are to modify the growth of the jaws in a prescribed growth pattern, however, this category is generally attached to the patients upper and lower molars or bicuspids by means of temporary stainless steel crowns or orthodontic bands. Retainer, Screw Expansion, Orthodontic.
FDA Recall
Terminated
·Sybron Dental Specialties·Product code DYJ·June 6, 2013
AOA Distalizer Lock Nut Screw, found in products listed as: Distal Jet, Spring Jet, Mesial Jet, and Uprighter Jet. Removable functional orthodontic appliances that are to modify the growth of the jaws in a prescribed growth pattern.
FDA Recall
Terminated
·Allesee Orthodontic Appliances·Product code DYJ·February 24, 2014
Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA
FDA Recall
Open, Classified
·DRG International, Inc.·Product code CDX·June 4, 2025
Sperm separation media are used to separate motile sperm from other constituents of semen.
FDA Recall
Open, Classified
·Fujifilm Irvine Scientific, Inc.·Product code MQL·November 2, 2023
GE Healthcare, Innova 2100IQ, Innova 3100IQ, Innova 4100IQ, Cardiovascular and Interventional Imaging System.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code OWB·October 21, 2011
MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated Body Temperature Screening module, for use as a medical diagnostic purposes as part of a telethermographic system utilizing FLIR cameras, Models A615sc and A315sc. Cameras are private labeled as MAX Basic, MAX 76 and MAX 307.
FDA Recall
Terminated
·Med-Hot Thermal Imaging, Inc.·Product code LHQ·January 14, 2017
ConMed System 2450 Electrosurgical Generator, REF 60-2450-230, 230V-240V, ConMed Electrosurgery, Centennial, CO. A general-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of high (HF) electrosurgical current through an accessory electrode for cutting and coagulation at the operative site.
FDA Recall
Terminated
·ConMed Electrosurgery·Product code GEI·December 27, 2010
ConMed System 2450 Electrosurgical Generator, REF 60-2450-100, 100 V, ConMed Electrosurgery, Centennial, CO. A general-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of high (HF) electrosurgical current through an accessory electrode for cutting and coagulation at the operative site
FDA Recall
Terminated
·ConMed Electrosurgery·Product code GEI·December 27, 2010
ConMed System 2450 Electrosurgical Generator, REF 60-2450-220, 220 V, ConMed Electrosurgery, Centennial, CO. A general-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of high (HF) electrosurgical current through an accessory electrode for cutting and coagulation at the operative site.
FDA Recall
Terminated
·ConMed Electrosurgery·Product code GEI·December 27, 2010
ConMed System 2450 Electrosurgical Generator, REF 60-2450-120-69, 120V, (Refurbished), ConMed Electrosurgery, Centennial, CO. A general-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of high (HF) electrosurgical current through an accessory electrode for cutting and coagulation at the operative site.
FDA Recall
Terminated
·ConMed Electrosurgery·Product code GEI·December 27, 2010
ConMed System 2450 Electrosurgical Generator, REF 60-2450-120, 120 V, ConMed Electrosurgery, Centennial, CO. A general-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of high (HF) electrosurgical current through an accessory electrode for cutting and coagulation at the operative site.
FDA Recall
Terminated
·ConMed Electrosurgery·Product code GEI·December 27, 2010
The CEP 8 SpectrumGreen (SG) ASR Probe Kit, 20ul (list 06J37-018) is an Analyte Specific Reagent (ASR) containing a single vial of CEP 8 spectrum green probe and a Certificate of Analysis (COA). Chromosome enumeration probes (CEP) are chromosome-specific FISH probes that hybridize to highly repetitive human satellite DNA sequences, usually located near centromeres. CEP signals enable the identification and enumeration of human chromosomes in interphase and metaphase cells from fresh and archived samples. The label for CEP 8 SG ASR Probe Kit indicates it is an Analyte Specific Reagent, and analytical and performance characteristics are not established.
FDA Recall
Terminated
·Abbott Molecular·Product code MVU·March 28, 2013
BD BBL TB Stain Kit K, Catalog (REF): 212522
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code JTS·February 12, 2025
Venue Go Standard Carts Ref: (H45181VC and H45103VCW), used with Venue Go R2, R3, R4 systems R2, R3, and R4 systems; pulsed doppler imaging system
FDA Recall
Open, Classified
·GE MEDICAL SYSTEMS, ISRAEL LTD. Nativ Haa??or Street no.·Product code IYN·September 6, 2023
Codman 1/4 x 1/4" Surgical Patties (20 pouches of 10 patties per box) Product code: 80-1399
FDA Recall
Terminated
·Codman & Shurtleff, Inc.·Product code HBA·July 16, 2010
American Surgical Delicot 20 mm x 60 mm Ref Number: 63-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Recall
Terminated
·American Surgical Company·Product code HBA·March 31, 2016
American Surgical Telfa 1/2" x 3" Ref Number: 80-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Recall
Terminated
·American Surgical Company·Product code HBA·March 31, 2016
SURG STRP 2X6 Model/Catalog Number: 801455. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
FDA Recall
Open, Classified
·Integra LifeSciences Corp.·Product code HBA·September 20, 2024