116 results
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21ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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1. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2001, 3" x 6", sterile; 2. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2000, 5" x 7", sterile; 3. Tech Medical Services, Inc. Detachable Endo Retrieval Pouch, REF TM2002, 8" x 10", sterile; 4. UNIMAX Detachable endo pocket, REF FEP936116, 3" x 6", sterile; 5. UNIMAX Detachable endo pocket, REF FEP979000, 8" x 10", sterile; 6. ConMed Corporation Detachable endo pocket, REF SB936, 3" x 6", sterile; 7. ConMed Corporation Detachable endo pocket, REF SB957, 5" x 7", sterile; 8. ConMed Corporation Detachable endo pocket, REF SB979, 7.5" x 9", sterile; 9. ConMed Corporation Detachable endo pocket, REF SB979-CA, 7.5 x 9", sterile; 10. ConMed Corporation Detachable endo pocket, REF SB936-CA, 3" x 6", sterile;
FDA Recall
Open, Classified
·UNIMAX MEDICAL SYSTEMS INC 8F-2, NO·Product code GCJ·June 25, 2024
STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen present in human nasal sample.
FDA Recall
Open, Classified
·SD Biosensor, Inc. 1556 Beon-Gil, Yeongtong C4th & 5th Floor Digital Empire·Product code QKP·January 31, 2022
Vertebral Motion Analyzer (VMA), VMA DataLink Software.2.3.231, 2.3.232. Product Usage: VMA software is a quantitative imaging software application intended to be used to process digital image files.
FDA Recall
Open, Classified
·Ortho Kinematics, Inc·Product code LLZ·August 12, 2016
Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-01 Software Version: N/A Product Description: 6 foot DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with the 91390 and 91393
FDA Recall
Open, Classified
·Spacelabs Healthcare, Inc.·Product code MHX·September 5, 2025
Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-12 Software Version: N/A Product Description: 12 foot DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with the 91390 and 91393
FDA Recall
Open, Classified
·Spacelabs Healthcare, Inc.·Product code MHX·September 5, 2025
Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0893-01 Software Version: N/A Product Description: 16 inch DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with the 91390 and 91393
FDA Recall
Open, Classified
·Spacelabs Healthcare, Inc.·Product code MHX·September 5, 2025
COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies Catalog No: I-111
FDA Recall
Open, Classified
·Lusys Laboratories, Inc.·Product code QKO·January 13, 2022
Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A
FDA Recall
Open, Classified
·New Standard Device Inc·Product code HXC·August 14, 2019
LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Saliva Test)
FDA Recall
Open, Classified
·Lusys Laboratories, Inc.·Product code QKP·January 13, 2022
Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Nasal Swab Test)
FDA Recall
Open, Classified
·Lusys Laboratories, Inc.·Product code QKP·January 13, 2022
Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;
FDA Recall
Open, Classified
·Vortex Surgical Inc.·Product code HQB·November 19, 2025
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
FDA Recall
Open, Classified
·CELLTRION USA INC·Product code QKP·February 25, 2022
GEM FLOW COUPLER Monitor, PN 5156-00000-011
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code DPW·June 19, 2023
EDI Novel Coronavirus COVID-19 IgG ELISA Kit, REF: KT-1032 Per label: This kit is intended for qualitative detection of human anti-COVID-19 IgG antibody in human serum. This kit is to be used as an aid for the detection of novel COVID-19. Patients with suspected clustering cases require diagnosis or differential diagnosis of novel coronavirus infection.
FDA Recall
Open, Classified
·Epitope Diagnostics, Inc.·Product code QKO·October 1, 2020
Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728)
FDA Recall
Open, Classified
·SD Biosensor, Inc. 1556 Beon-Gil, Yeongtong C4th & 5th Floor Digital Empire·Product code QKP·March 31, 2023
DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastener
FDA Recall
Open, Classified
·Smith & Nephew, Inc.·Product code HTY·July 9, 2024
DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener
FDA Recall
Open, Classified
·Smith & Nephew, Inc.·Product code HTY·July 9, 2024
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: X8, X10, X12 Product Description: The X8 X10 X12 Patient Monitor (hereinafter called X series) can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time. Component: No
FDA Recall
Open, Classified
·Edan Diagnostics·Product code MHX·October 24, 2025
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3 Product Description: The iM3 has three work modes, Monitor, Spot and Round, to measure physiological parameters, including non-invasive blood pressure (NIBP), oxygen saturation of the blood (SpO2), pulse rate (PR), and Quick TEMP/Infrared TEMP (TEMP). iM3 capabilities include storing, displaying measuring data. When necessary, alarms will be produced so that doctors and nurses can manage patient care appropriately. Component: No
FDA Recall
Open, Classified
·Edan Diagnostics·Product code DQA·October 24, 2025
Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CMS Product Description: MFM-CMS is a central monitoring system product, which can connect and manage information from EDAN medical devices. MFM-CMS offers central management for monitoring information from the medical devices. All these collected information can be displayed, printed, alarmed and recorded. Component: No
FDA Recall
Open, Classified
·Edan Diagnostics·Product code MHX·October 24, 2025