35 results
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21ms
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Sources: EU EUDAMED, US FDA
SW
FDA UDI
SW SAFETY SOLUTIONS INC.·00616489004028·PowerChem Neoprene Exam Gloves, Small
SCREENERS PHENCYCLIDINE (PCP) TEST, DRUGSCREEN DIP PHENCYCLIDINE (PCP) TEST
FDA 510(k)
FDA Unclassified
·Unknown
CUSTOM PROCEDURE KIT
FDA UDI
MEDIVATORS INC.·40677964003835·The ENDO CARRY-ON Procedure Kit contains all of...
Waterlase Laser Tips
FDA UDI
Biolase, Inc.·00647529002957·A Z2 tip kit containing 5 single-use tips inte...
PediFlex
FDA UDI
ORTHOPEDIATRICS CORP.·00841132133354·PEDIFLEX INSTRUMENT #1 TRAY
MAGNA 5000 PHASED ARRAY CTL SPINE COIL
FDA 510(k)
FDA Class 2
·Radiology
ELECSYS B-CROSSLAPS CALCHECK
FDA 510(k)
FDA Class 1
·Clinical Chemistry
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 25, 2008
BD SAFE-CLIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·August 6, 2020
IMMULITE 2000 XPI
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code LTJ·March 12, 2013
LASIK LASER DEVICE
FDA Adverse Event
Injury
·Product code LZS·February 17, 2011
PINNACLE MULTIHOLE II CUP 48MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWA·February 19, 2008
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·August 19, 2013
SINGLE USE DISTAL COVER
FDA Adverse Event
Injury
·OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT·Product code FDT·September 5, 2024
CHROMID® CPS ELITE AGAR
FDA Adverse Event
Malfunction
·BIOMERIEUX S.A.·Product code JXA·March 4, 2020
Impella CP Smart Assist Set; Product Code: 1000402;
FDA Recall
Open, Classified
·Abiomed, Inc.·Product code OZD·August 5, 2024
Impella CP Smart Assist Set; Product Code: 1000402;
FDA Enforcement
Class II
·Ongoing·Abiomed, Inc.·September 11, 2024
Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurations and corresponding product codes. 1. Purge Cassette, 5 Pack; Product Code: 0043-0003. 2. Impella RP US Pump Set; Product Code: 004334. 3. Purge Cassette, Packaged; Product Code: 0043-0002. Also included inside Product Code 0043-0003 above. Product Code 0043-0002 also includes innermost packaged product with Product Code 0043-0001. 4. Impella 2.5 Set; Product Code: 004413 (Customer facing code 005040). 5. Impella RP Pump Set, EU; Product Code: 0046-0011. 6. Impella CP Pump Set, EU; Product Code: 0048-0002. 7. Impella CP Pump Set BR; Product Code: 0048-0002-BR. 8. Impella CP Smart Assist Set, EU; Product Code: 0048-0014 (Also inclusive of codes 0048-0047 and 1000402 listed below). 9. Impella CP Smart Assist Set, Canada; Product Code: 0048-0044. 10. Impella CP Smart Assist Set APAC; Product Code: 0048-0047 (inclusive under code 0048-0014). 11. Impella 5.0 IMC Pump Set EU; Product Code: 005060. 12. Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002. 13. Impella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004. 14. 5.5 Accessories AU; Product Code: 1000362. 15. Impella CP Smart Assist Set; Product Code: 1000402 (inclusive under code 0048-0014).
FDA Recall
Open, Classified
·Abiomed, Inc.·Product code OZD·February 18, 2026
HemaSyst, Dual Cannula Tip with Adapter 16 ga. x 4" (10.2 cm). Product is labeled in part:"***Pouch label***HAEMACURE***HemaSyst***tm***Contents: One ***DUAL CANNULA TIP***WITH ADAPTER***16 ga. x 4" (10.2 cm)***REF H-1604*** CE 0297***LOT 111144***2014/10***40680b/20004-02***CAUTION: U.S. Federal Law restricts this device to sale by or on the order of a licensed physician (or properly licensed practitioner).***Contents of unopened undamaged package are sterile***CE 0297***Manufactured by: ***Micromedics*** St. Paul, MN 55121-1385 USA***Distributed by:***Haemacure Corporation***Sarasota, FL 34236 USA***Toll Free 1-877-872-4583***www.haemacure.com***Box label***Contents: 5 packages of 1 each***DUAL CANNULA TIP***WITH ADAPTER***16 ga. x 4" (10.2 cm)***REF H-1604***CE 0297***STERILE EO***LOT 11144***2014/10***40681B/20544***". Sterile, single-use instrument for the application of two liquids.
FDA Recall
Terminated
·Haemacure Corporation·Product code KYZ·November 16, 2009
Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Product Code 005062 - Impella 5.0 (3) Product Code 005082- Impella LD (7) Product Codes 0550-0008 and 1000100 - Impella 5.5 with SmartAssist (8) Product Code 0048-0032 - Impella CP (9) Product Codes 1000080 and 0048-0045 - Impella CP with SmartAssist ***Updated February 2024*** (10) 004413 - Impella 2.5 Set (12) 0046-0026 - Impella 5.0 Pump Set ROW (13) 0046-0037 - Impella 5.0 Pump Set APAC (15) 004680-AU - 5.0 Pump Set AU (16) 0048-0002 - Impella CP Pump Set, EU (17) 0048-0002-BR - Impella CP Pump Set BR (18) 0048-0004 - Impella CP Pump Set, Canada (19) 0048-0014 - Impella CP Smart Assist Set, EU (20) 0048-0024-JP - Impella CP Smart Assist Set, JP (21) 0048-0044 - Impella CP Smart Assist Set, Canada (22) 0048-0047 - Impella CP Smart Assist Set APAC (23) 005040 - Impella 2.5 IMC Pump Set EU (24) 005048-JP - Impella 2.5 Pump Set, Japan (25) 005060 - Impella 5.0 IMC Pump Set EU (26) 005064 - Impella 5.0 IMC Pump Set Canada (27) 005066-JP - Impella 5.0 Pump Set, Japan (28) 0550-0002 - Impella 5.5 with SmartAssist Set, EU (29) 0550-0004 - Impella 5.5 with SmartAssist Set, CA (30) 1000115 - Impella CP Pump set, APAC (31) 1000211 - Impella 5.5 SmartAssist Set, JP (32) 1000302 - Impella CP with SmartAssist APAC (33) 1000361 - Impella 5.5 Set AU (34) 1000402 - Impella CP Smart Assist Set ***Updated March 15, 2024*** The following products were removed from the list of affected products because the Right-side devices are not in the scope of the warning to avoid left ventricle perforation: (4) Product Code 004334 - Impella RP (5) Product Code 0046-0035 - Impella RP with SmartAssist (6) Product Code 1000323 - RP Flex with SmartAssist (11) 0046-0011 - Impella RP Pump Set, EU (14) 0046-0039 - Impella RP Set APAC
FDA Recall
Open, Classified
·Abiomed, Inc.·Product code OZD·December 27, 2023