20 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NuVasive® Interfixated Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
Optiview
FDA UDI
ORMCO CORPORATION·00889989059984·OPTIVIEW SMALL UNIV LIP and CHEEK RETRACTOR - 2PK
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319705315·Crile-Wood Needle Holder 7" (17.5cm), serrated ...
Medallion®
FDA UDI
Merit Medical Systems, Inc.·00884450055502·
BPR Medical
FDA UDI
BPR MEDICAL LIMITED·05060274504388·Microdial Flowmeter - Range A 0.02 - 3 l/min - ...
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K1100510·Caddie, 5.5mm Screws
Coaxial needle
FDA UDI
Möller Medical GmbH·04260277175153·
INSTANT-VIEW MILTI-DRUG OF ABUSE URINE TEST (PANEL, CUP), INSTANT-VERDICT MULTI-DRUG OF ABUSE URINE TEST (PANEL, CUP)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SPECIMEN RETRIEVAL SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 22, 2020
BAROUK SCREW - 3 0MM X 32MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HWC·April 7, 2020
V.A.C. GRANUFOAM DRESSING
FDA Adverse Event
Injury
·KINETIC CONCEPTS, INC.·Product code OMP·May 6, 2020
CONCERTO II CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·October 10, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 10, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 13, 2011
The recalled product is the Disposable biopsy plate, part #U1-150131. The biopsy plate is labeled in part: Disposable Biopsy Plate, part U1-150131, For Use with the Liberty 9000 8-Channel Breast Coil, USA Instruments, Inc., Aurora, OH, sterile. The breast biopsy plate is used with GE coils and with OEM coils (coils manufactured for Philips and Hitachi by USA Instruments) during Magnetic Resonance breast biopsy procedures. The disposable biopsy plate for use with GE coils is packaged and sold as a part of catalogue U1-160051, U1-150190, U1-150131. The disposable biopsy plate for use with OEM coils is packaged and sold as part of catalogue U1-150226, U1-150190, U1-155068, U1-160016, U1-160052, U1-160085, U1-160166, U1-160175, 2412158, 2416938, 2417842, and U1-150131.
FDA Recall
Terminated
·USA Instruments Incorporated·Product code LNH·January 31, 2007
Applied Medical's Inzii¿ 12/15mm Retrieval System. Applieds Inzii Tissue Retrieval Bag, Model Number CD004, is classified as a Class II device. It was cleared to market via 510(k) filing K060051. The retrieval bag is a disposable specimen retrieval bag intended for use as receptacle for the collection of tissue, organs, and calculi during laparoscopic procedures. Applieds CD004 has a shelf life of three years. It is provided sterile and packaged in a heat sealed Tyvek pouch.
FDA Enforcement
Class II
·Terminated·Applied Medical Resources Corp·November 20, 2013
Applied Medical's Inzii 12/15mm Retrieval System. Applieds Inzii Tissue Retrieval Bag, Model Number CD004, is classified as a Class II device. It was cleared to market via 510(k) filing K060051. The retrieval bag is a disposable specimen retrieval bag intended for use as receptacle for the collection of tissue, organs, and calculi during laparoscopic procedures. Applieds CD004 has a shelf life of three years. It is provided sterile and packaged in a heat sealed Tyvek pouch.
FDA Recall
Terminated
·Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa·Product code GCJ·October 21, 2013
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728332 - IQon Spectral CT : IQon Spectral CT
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 7, 2021
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026