19 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BIOPRO POLAR HEAD
FDA 510(k)
FDA Class 2
·Orthopedic
SampLok® Adapter Cap 3 Insert
FDA UDI
ITL ASIA PACIFIC SDN. BHD.·09555240401533·SampLok® Adaptor Cap 3 (SAC 3) Insert is an opt...
Oticon
FDA UDI
Oticon A/S·05707131165527·ACTO, ITC/ITE AP BE
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450480496·
Meritrans®
FDA UDI
Merit Medical Systems, Inc.·00884450048542·
Indus®
FDA UDI
SPINEFRONTIER, INC.·00190361001430·Invue Max, Four Level ACP, 61mm
UA Impression Sleeve
FDA UDI
BICON, LLC·00813110027016·UA6 LP Impression Sleeves (3)
N/A
FDA UDI
Doppkon GmbH & Co. KG·04262494464218·Cup Forceps Straight Jaw
D 5.0mm, WL 150mm
CAYMAN SCREWS MODEL K2-12-1000-XX, K2-12-1001-XX
FDA 510(k)
FDA Class 2
·Orthopedic
SPL-50 SPIROLYSER
FDA 510(k)
FDA Class 2
·Anesthesiology
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·December 17, 2010
VOYAGER NC CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·December 4, 2008
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·May 8, 2013
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·September 19, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 24, 2011
EMAG®
FDA Adverse Event
Malfunction
·BIOMERIEUX ITALIA S.P.A.·Product code JJH·May 29, 2018
Brand Name: RX Accunet Embolic Protection System Common Name: RX Accunet EPS. Part Numbers: 101649-45, 1011649-55, 1011649-65, 1011649-75, 1011650-55, 1011650-65, 1011651-45, 1011651-55. The RX Accunet EPS is indicated for use as a guide wire and embolic protection system.
FDA Enforcement
Class II
·Terminated·Abbott Vascular·February 6, 2013
CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).
FDA Enforcement
Class II
·Terminated·CME America, LLC·December 9, 2020
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025