919 results
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17ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solution
FDA Enforcement
Class II
·Ongoing·Contamac Solutions, Inc.·June 18, 2025
Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name on the label for the HemoPoint H2 shows Manufactured by EKF-diagnostic GmbH, Germany.
FDA Enforcement
Class II
·Terminated·Stanbio Laboratory, LP·September 5, 2018
Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·February 11, 2015
Acrobat V Vacuum Off-Pump System OM-9100S Acrobat SUV Vacuum Off-Pump System OM-9000S Axius Xpose 3 Access Device XP-3000 XPOSE 4 Access Device XP-4000 Acrobat V Vacuum Off-Pump System Each Acrobat V Vacuum Off-Pump system is intended for use during performance of cardiac surgical procedures through a sternotomy incision approach.
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·November 5, 2014
See RES for complete list. Medline Convenience Kits: 1) OPEN HEART CDS, Model Number:CDS840015AQ; 2) OPEN HEART CDS, Model Number:CDS840015AQ; 3) OPEN HEART CDS, Model Number:CDS840023T; 4) OFF PUMP CABG CDS, Model Number:CDS840087AI; 5) OFF PUMP CABG CDS, Model Number:CDS840087AK; 6) OFF PUMP CABG CDS, Model Number:CDS840087AL; 7) OFF PUMP CABG CDS, Model Number:CDS840087AM; 8) OPEN HEART, Model Number:CDS840150S; 9) OPEN HEART, Model Number:CDS840150T;
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·May 13, 2026
IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm) 150 ml Burette Set (w/Shut Off), MicroClave, Clamp, REF: B9213; 70" (178 cm) 150 ml Burette Set (Clave, Shut-Off) w/3-Way Stopcock, Clave, Graduated Adapter, Rotating Luer, 1 Ext, REF: B9732; 80" (203 cm) Y-Type 150 ml, Burette Set (Clave, Shut-Off), w/3-Way Stopcock, Clave, Graduated Adapter, Rotating, Luer, 1 Ext, REF: B9733; 53 cm (21") Add-On 150 ml Burette Set (Clave, Shut-Off), Vented Cap, REF: 011-C7014
FDA Enforcement
Class I
·Ongoing·ICU Medical, Inc.·October 29, 2025
Manifold rotator (Component): a. 250 2 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1232MR b. 250 3 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1233MR c. 550 2 GANG MANIFOLD ROTATOR, OPEN HANDLE, Model Number MX1322MR d. 550 3 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1333MR. Stopcocks and manifolds are used to control the direction of IV fluid flow. component of extravascular blood-pressure Transducer.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·April 28, 2021
Curaplex manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Curaplex Adult Premium BVM with Bag Reservoir, Manometer, Filter, Peep Valve & Mask, REF # 2442-BVMPAD; 2. Curaplex Child Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter & Mask, REF # 2442-BVMPCH; 3. Curaplex Child Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter, Infant and Neonate Mask, REF # 2442-BVMCIN; 4. Curaplex Infant Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter & 2 Masks, REF # 2442-BVMPIN; 5. Curaplex Small Adult Pediatric Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter, PEEP Valve and 2 Masks, REF # 2442-BVMPSA.
FDA Enforcement
Class II
·Ongoing·SunMed Holdings, LLC·November 29, 2023
Stopcock rotator (Component): a. 1050 STOPCOCK ROTATOR, OFF HANDLE, Model Number MX1431MR b. 1050 STOPCOCK LEFT ROTATOR, OFF HANDLE, Model Number MX1431MRL c. 700 PSI STPCK W/ ROTATOR, Model Number MX4331R. Stopcocks and manifolds used to control the direction of IV fluid flow.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·April 28, 2021
1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL
FDA Enforcement
Class II
·Ongoing·Smiths Medical Asd Inc·January 24, 2024
Flush Kit w 3 Way Off Stopcock Product Usage: Flush Kit
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·August 8, 2012
Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·March 4, 2026
High Pressure Stopcock (3-Way, Luer Lock, Off). Product Usage: For IV.
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·August 8, 2012
FISTULA ON-OFF KIT. Medical convenience kit, Avid Medical Part Number: MMTN020.
FDA Enforcement
Class I
·Terminated·Avid Medical, Inc.·June 16, 2021
MEDLINE Kits, trays, and packs labeled as follows: DIALYSIS ON/OFF BNDLE -NO DRSG, REF DYNDC3088
FDA Enforcement
Class I
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·March 6, 2024
Total Temporomandibular Joint Replacement System- 50mm Rt Stand Off Ti Mand Reconstruction of the temporomandibular joint
FDA Enforcement
Class II
·Terminated·Biomet Microfixation, LLC·December 17, 2014
Total Temporomandibular Joint Replacement System- 50mm Lft Stand Off Ti Mand Reconstruction of the temporomandibular joint
FDA Enforcement
Class II
·Terminated·Biomet Microfixation, LLC·December 17, 2014
Total Temporomandibular Joint Replacement System- 45mm Rt Stand Off TI Mand Reconstruction of the temporomandibular joint
FDA Enforcement
Class II
·Terminated·Biomet Microfixation, LLC·December 17, 2014
Total Temporomandibular Joint Replacement System- 45mm Lft Stand Off Ti Mand Reconstruction of the temporomandibular joint
FDA Enforcement
Class II
·Terminated·Biomet Microfixation, LLC·December 17, 2014
FISTULA (ON/OFF) ALL IN ONE BAG. Medical convenience kit, Avid Medical Part Number: VAMK024-03
FDA Enforcement
Class I
·Terminated·Avid Medical, Inc.·June 16, 2021