330 results · 25ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Prescription eyeglass safety lenses. Vision correction

FDA Recall
Terminated ·Eyemart Express Ltd·Product code HQG·September 12, 2014

Safety glasses made with "Rage" frames manufactured between February 20, 2014 and February 25, 2014. The color of the frames of the recalled glasses were either white or black. Safety Eye wear

FDA Recall
Terminated ·Wal Mart Stores, Inc·Product code HQG·February 26, 2014

Polycarbonate prescription single vision lenses for use in sport goggles. To be worn by a customer in a sport goggle frame to provide corrective refraction in accordance with the customer's prescription. Per the customer's request, some of the devices may also provide protection from bright sunlight.

FDA Recall
Terminated ·Luxottica Optical Manufacturing·Product code HQG·June 30, 2010

Frames Direct Prescription Spectacle Lenses included in the frame brands

FDA Recall
Terminated ·Frames Direct·Product code HQG·March 18, 2020

DELFIA hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: A007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG) in serum.

FDA Recall
Open, Classified ·PerkinElmer Life and Analytical Sciences, Wallac, OY Mustionkatu 6·Product code JHJ·January 10, 2019

AutoDELFIA hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-112 - Product Usage: Quantitative determination of human gonadotrophin (hCG).

FDA Recall
Open, Classified ·PerkinElmer Life and Analytical Sciences, Wallac, OY Mustionkatu 6·Product code JHJ·January 10, 2019

AutoDELFIA hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG).

FDA Recall
Open, Classified ·PerkinElmer Life and Analytical Sciences, Wallac, OY Mustionkatu 6·Product code JHJ·January 10, 2019

In vitro Diagnostic-Clinitest hCG Cassette Pregnancy Test, Radio immunoassay for Human Chorionic Gonadotropin (hCG) test system Product Number: 1760 The Clinitest hCG Pregnancy Test is for in vitro diagnostic use as a qualitative method in the rapid detection of human chorionic gonadotropin (hCG) in urine specimens.

FDA Recall
Terminated ·Siemens Medical Solutions Diagnostics·Product code JHI·April 4, 2008

Alere" hCG Combo Cassette (20/10 mIU/mL) Kit. Product Usage: The AlereTM hCG Combo (20/10 mIU/mL) test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine, as an aid in the early detection of pregnancy. It is for healthcare professionals only.

FDA Recall
Terminated ·Alere San Diego, Inc.·Product code JHI·April 16, 2013

CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Product Usage - CONSULT Diagnostics hCG Controls are intended to validate the performance of qualitative hCG urine procedures and immunochromatographic devices.

FDA Recall
Terminated ·Biochemical Diagnostics Inc·Product code JJX·September 14, 2015

Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the early confirmation of pregnancy. Model/Catalog Number: 1004

FDA Recall
Open, Classified ·Princeton Biomeditech Corp·Product code JHI·August 23, 2024

Clinitest hCG Cassette Pregnancy Test, Radio immunoassay for Human Chorionic Gonadotropin (hCG) test system Product Number: 1760

FDA Recall
Terminated ·Siemens Medical Solutions Diagnostics·Product code JHI·October 17, 2007

HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter. For hysterosonography and hysterosalpingography, gynecological use.

FDA Recall
Terminated ·Catheter Research, Inc·Product code HGS·April 7, 2015

Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part Numbers C-PTISYJ-100-HC-G-EU-FLEX8.5 (G57725), C-PTISYJ-100-HC-G-NA-FLEX7.5 (G57720), C-PTISYJ-100-HC-G-NA-FLEX8.5 (G57721), C-PTISY-100-HC-G-NA-FLEX8.5 (G57717), C-PTISY-100-HC-G-NA-FLEX7.5 (G57716)

FDA Recall
Open, Classified ·Cook Incorporated·Product code JOH·April 7, 2023

Cardinal Health hCG Cassette Rapid Test, Part Number: B1077-22 (Mfg PN: 4582105026) The SP hCG Cassette Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in the early detection of pregnancy. This test is for professional use.

FDA Recall
Terminated ·Alere San Diego, Inc.·Product code JHI·January 21, 2013

Access Immunoassay Systems Total hCG. The Access Total hCG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total hCG levels in human serum and plasma using the Access Immunoassay Systems.

FDA Recall
Terminated ·Beckman Coulter Inc.·Product code JHI·March 5, 2009

IMx Total B-hCG Reagent is composed of one bottle of Anti B-hCG Coated Microparticles, one bottle of Anti B-hCG Alkaline Phosphatase Conjungate, one bottle of 4-Methylumbelliferyl Phosphate and one bottle of Specimen Diluent.

FDA Recall
Terminated ·Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila·Product code JHI·April 10, 2007

Tosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for BHCG Part number 020361 The AIA-Pack BHCG Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK BHCG assay

FDA Recall
Terminated ·Tosoh Bioscience Inc·Product code JIT·August 7, 2020

Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part Numbers C-PTIS-100-HC-G-EU-FLEX7.5 (G57695), C-PTIS-100-HC-G-EU-FLEX8.5 (G57696), C-PTIS-100-HC-G-NA-FLEX7.5 (G57691), C-PTIS-100-HC-G-NA-FLEX8.5 (G57692)

FDA Recall
Open, Classified ·Cook Incorporated·Product code JOH·April 7, 2023

AxSYM Total B-hCG Reagent Pack

FDA Recall
Terminated ·Abbott Health Products, Inc.·Product code JHI·July 7, 2004