17 results
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32ms
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Sources: EU EUDAMED, US FDA
CO2 REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BLADDER CATH KIT W/OUT CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AUTOMATED RHEMATOID FACTOR TEST (ARFT)
FDA 510(k)
FDA Class 2
·Immunology
MEDTRONIC EXTENDED
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 6, 2024
MEDTRONIC EXTENDED
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 6, 2024
CONVEEN CONTOUR LEG BAG
FDA Adverse Event
Malfunction
·COLOPLAST CORPORATION·Product code FAQ·October 7, 2014
COBAS AMPLIPREP / COBAS AMPLICOR HCV TEST, V2.0 CE-IVD
FDA Adverse Event
ROCHE MOLECULAR SYSTEMS·Product code MZP·December 19, 2012
NEXGEN STEMMED NONAUGMENTABLE TIBIA
FDA Adverse Event
Injury
·ZIMMER·Product code JWH·October 19, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 30, 2014
EA DELTA CER INSERT 36IDX52OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code MRA·April 10, 2023
Coloplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5174. Urine Collection Bag.
FDA Enforcement
Class II
·Terminated·Coloplast Manufacturing US, LLC·November 5, 2014
Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M, CB-13152-03M, CB-15152-03M, CB-17152-03M. Component of ELEOS LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025
Clearview Total Uterine Manipulator (model UM750), The device is labeled in part, "ClearView(R) TOTAL, 7 cm* * *CLINICAL INNOVATIONS Manufacturer: Clinical Innovations, LLC* * *Reorder Number: UM750* * *LOT 181183* * *." Each device is accompanied by Instruction for Use which is similarly labeled.
FDA Recall
Terminated
·Clinical Innovations, LLC·Product code LKF·May 30, 2019
Custom procedure packs, containing banded 4x4 Raytec 16ply gauze sponges. 1) Regard, PACEMAKER, Item 800221010, Lot # 82466. 2) Regard, BASIC, Item 800109003 Lot # 83411. 3) Regard, MAJOR EAR, Item 800070009, Lot # 82442. 4) Regard, NEURO, Item 800040011, Lot # 82504. 5) Regard, LAP CHOLE, Item 800003011, Lot # 82497. 6) Regard, SHOULDER ARTHRO, Item 800075010, Lot # 82490. 7) Regard, CERVICAL, Item 800058007, Lot # 82592. 8) Regard, ARTHROSCOPY, Item 800027008, Lot # 82582. 9) Regard, MAJOR SURGERY, Item 800013010, Lot # 82844. 10) Regard, GENERAL SURGERY, Item 800057012, Lot # 82832. 11) Regard, SEPTO SINUS ENDO, Item 800024006, Lot # 82876. 12) Regard, MINOR FMOL-LADY OF THE LAKE, Item 800019009, Lot # 82893. 13) Regard, KNEE ARTHRO, Item 800072009, Lot # 83058. 14) Regard, LAP, Item 800096005, Lot # 83139. 15) Regard, KNEE ARTHROSCOPY, Item 800121, Lot # 83251. 16) Regard, CYSTOSCOPY, Item 800093007, Lot # 83138. 17) Regard, LAP CHOLE, Item 800035007, Lot # 83257. 18) Regard, PERIPHERAL VASCULAR, Item 800007011, Lot # 83106. 19) Regard, PACEMAKER, Item 800083006, Lot # 82886. 20) Regard, I&D, Item 800056005, Lot # 83135. 21) Regard, HEAD & NECK, Item 800068010, Lot # 83050. 22) Regard, ROBOTICS, Item 800103007, Lot # 83264. 23) Regard, MAJOR EAR, Item 800070010, Lot # 82879. 24) Regard, ORTHO EXTREMITY, Item 800042009, Lot # 83383. 25) Regard, CRANIOTOMY, Item 800025015, Lot # 83271. 26) Regard, MINOR ORTHO, Item 800020007, Lot # 83583. 27) Regard, VATS, Item 800118001, Lot # 83421. 28) Regard, ARTHROSCOPY, Item 800027008, Lot # 83560. 29) Regard, OPEN HEART, Item 800023010, Lot # 83273. 30) Regard, PERIPHERAL VASCULAR, Item 800018011, Lot # 83575. 31) Regard, GENERAL PROCEDURE, Item 800000008, Lot # 83576. 32) Regard, DR WHITE OPEN HRT A&B, Item 800045012, Lot # 82847. 33) Regard, NEURO, Item 800008008, Lot # 83598. 34) Regard, LAPAROSCOPY, Item 880320008, Lot # 82472. 35) Regard, PACEMAKER, Item 880074023, Lot # 82417. 36) Regard, THYROID, Item 880425002, Lot # 82389. 37) Regard, LAPAROSCOPY, Item 880350012, Lot # 82473. 38) Regard, CHEST, Item 880373005, Lot # 82427. 39) Regard, BASIC CATARACT, Item 880348006, Lot # 82501. 40) Regard, CCOR HAND, Item 880337009, Lot # 82496. 41) Regard, CRANIOTOMY, Item 880396004, Lot # 82507. 42) Regard, TUR CYSTO, Item 880357006, Lot # 82574. 43) Regard, TOTAL HIP, Item 880266, Lot # 82478. 44) Regard, DAVINCI, Item 880132021, Lot # 82469. 45) Regard, KNEE ARTHROSCOPY, Item 880368, Lot # 82485. 46) Regard, UROLOGY, Item 880306010, Lot # 82584. 47) Regard, MINOR BREAST, Item 880195017, Lot # 82588. 48) Regard, LABOR & DELIVERY, Item 880081018, Lot # 82600. 49) Regard, PELVIC PROCEDURE, Item 880214016, Lot # 82597. 50) Regard, CCOR MINOR, Item 880336010, Lot # 82593. 51) Regard, YOUNG LUMBAR, Item 880432005, Lot # 82594. 52) Regard, PACEMAKER, Item 880418003, Lot # 82606. 53) Regard, LOCAL, Item 880087014, Lot # 82828. 54) Regard, COLON LITHOTOMY, Item 880395002, Lot # 82825. 55) Regard, EYE, Item 880099029, Lot # 82882. 56) Regard, FESS, Item 880404001, Lot # 83033. 57) Regard, CYSTO, Item 880312009, Lot # 82880. 58) Regard, EXTREMITY PACK, Item 880167018, Lot # 82887. 59) Regard, PHERIPHERAL VASC, Item 880077, Lot # 83048. 60) Regard, T & A, Item 880423002, Lot # 83073. 61) Regard, C CABG A & B, Item 880080, Lot # 83042. 62) Regard, DR MARBARGER, Item 880079011, Lot # 83124. 63) Regard, MPR LOCAL, Item 880360006, Lot # 83133. 64) Regard, KNEE ARTHROSCOPY, Item 880268, Lot # 83095. 65) Regard, MINOR PROCEDURE, Item 880261009, Lot # 83132. 66) Regard, EXTREMITY, Item 880262009, Lot # 83071. 67) Regard, LAPAROSCOPY, Item 880102018, Lot # 83238. 68) Regard, GENERAL LAPAROSCOPY, Item 880405002, Lot # 83254. 69) Regard, MAJOR PROCEDURE, Item 880270008, Lot # 83240. 70) Regard, YOUNG LUMBAR, Item 880432005, Lot # 83232. 71) Regard, MINOR LITHOTOMY, Item 88
FDA Recall
Terminated
·ROi CPS LLC·Product code EFQ·November 9, 2020
Custom procedure packs, containing banded 4x4 Raytec 16ply gauze sponges. 1) Regard, PACEMAKER, Item 800221010, Lot # 82466. 2) Regard, BASIC, Item 800109003 Lot # 83411. 3) Regard, MAJOR EAR, Item 800070009, Lot # 82442. 4) Regard, NEURO, Item 800040011, Lot # 82504. 5) Regard, LAP CHOLE, Item 800003011, Lot # 82497. 6) Regard, SHOULDER ARTHRO, Item 800075010, Lot # 82490. 7) Regard, CERVICAL, Item 800058007, Lot # 82592. 8) Regard, ARTHROSCOPY, Item 800027008, Lot # 82582. 9) Regard, MAJOR SURGERY, Item 800013010, Lot # 82844. 10) Regard, GENERAL SURGERY, Item 800057012, Lot # 82832. 11) Regard, SEPTO SINUS ENDO, Item 800024006, Lot # 82876. 12) Regard, MINOR FMOL-LADY OF THE LAKE, Item 800019009, Lot # 82893. 13) Regard, KNEE ARTHRO, Item 800072009, Lot # 83058. 14) Regard, LAP, Item 800096005, Lot # 83139. 15) Regard, KNEE ARTHROSCOPY, Item 800121, Lot # 83251. 16) Regard, CYSTOSCOPY, Item 800093007, Lot # 83138. 17) Regard, LAP CHOLE, Item 800035007, Lot # 83257. 18) Regard, PERIPHERAL VASCULAR, Item 800007011, Lot # 83106. 19) Regard, PACEMAKER, Item 800083006, Lot # 82886. 20) Regard, I&D, Item 800056005, Lot # 83135. 21) Regard, HEAD & NECK, Item 800068010, Lot # 83050. 22) Regard, ROBOTICS, Item 800103007, Lot # 83264. 23) Regard, MAJOR EAR, Item 800070010, Lot # 82879. 24) Regard, ORTHO EXTREMITY, Item 800042009, Lot # 83383. 25) Regard, CRANIOTOMY, Item 800025015, Lot # 83271. 26) Regard, MINOR ORTHO, Item 800020007, Lot # 83583. 27) Regard, VATS, Item 800118001, Lot # 83421. 28) Regard, ARTHROSCOPY, Item 800027008, Lot # 83560. 29) Regard, OPEN HEART, Item 800023010, Lot # 83273. 30) Regard, PERIPHERAL VASCULAR, Item 800018011, Lot # 83575. 31) Regard, GENERAL PROCEDURE, Item 800000008, Lot # 83576. 32) Regard, DR WHITE OPEN HRT A&B, Item 800045012, Lot # 82847. 33) Regard, NEURO, Item 800008008, Lot # 83598. 34) Regard, LAPAROSCOPY, Item 880320008, Lot # 82472. 35) Regard, PACEMAKER, Item 880074023, Lot # 82417. 36) Regard, THYROID, Item 880425002, Lot # 82389. 37) Regard, LAPAROSCOPY, Item 880350012, Lot # 82473. 38) Regard, CHEST, Item 880373005, Lot # 82427. 39) Regard, BASIC CATARACT, Item 880348006, Lot # 82501. 40) Regard, CCOR HAND, Item 880337009, Lot # 82496. 41) Regard, CRANIOTOMY, Item 880396004, Lot # 82507. 42) Regard, TUR CYSTO, Item 880357006, Lot # 82574. 43) Regard, TOTAL HIP, Item 880266, Lot # 82478. 44) Regard, DAVINCI, Item 880132021, Lot # 82469. 45) Regard, KNEE ARTHROSCOPY, Item 880368, Lot # 82485. 46) Regard, UROLOGY, Item 880306010, Lot # 82584. 47) Regard, MINOR BREAST, Item 880195017, Lot # 82588. 48) Regard, LABOR & DELIVERY, Item 880081018, Lot # 82600. 49) Regard, PELVIC PROCEDURE, Item 880214016, Lot # 82597. 50) Regard, CCOR MINOR, Item 880336010, Lot # 82593. 51) Regard, YOUNG LUMBAR, Item 880432005, Lot # 82594. 52) Regard, PACEMAKER, Item 880418003, Lot # 82606. 53) Regard, LOCAL, Item 880087014, Lot # 82828. 54) Regard, COLON LITHOTOMY, Item 880395002, Lot # 82825. 55) Regard, EYE, Item 880099029, Lot # 82882. 56) Regard, FESS, Item 880404001, Lot # 83033. 57) Regard, CYSTO, Item 880312009, Lot # 82880. 58) Regard, EXTREMITY PACK, Item 880167018, Lot # 82887. 59) Regard, PHERIPHERAL VASC, Item 880077, Lot # 83048. 60) Regard, T & A, Item 880423002, Lot # 83073. 61) Regard, C CABG A & B, Item 880080, Lot # 83042. 62) Regard, DR MARBARGER, Item 880079011, Lot # 83124. 63) Regard, MPR LOCAL, Item 880360006, Lot # 83133. 64) Regard, KNEE ARTHROSCOPY, Item 880268, Lot # 83095. 65) Regard, MINOR PROCEDURE, Item 880261009, Lot # 83132. 66) Regard, EXTREMITY, Item 880262009, Lot # 83071. 67) Regard, LAPAROSCOPY, Item 880102018, Lot # 83238. 68) Regard, GENERAL LAPAROSCOPY, Item 880405002, Lot # 83254. 69) Regard, MAJOR PROCEDURE, Item 880270008, Lot # 83240. 70) Regard, YOUNG LUMBAR, Item 880432005, Lot # 83232. 71) Regard, MINOR LITHOTOMY, Item 88
FDA Enforcement
Class II
·Terminated·ROi CPS LLC·January 6, 2021
OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Tibial Components, with Product Line Numbers: 200-11-XX, 200-12-XX, 200-13-XX, 200-14-XX, 200-15-XX, 200-16-XX; b. OPTETRAK All-polyethylene PS Tibial Components, with Product Line Numbers: 204-11-XX, 204-12-XX, 204-13-XX, 204-14-XX, 204-15-XX, 204-16-XX; c. OPTETRAK HI-FLEX PS Polyethylene Tibial Inserts, with Product Line Numbers: 244-20-XX, 244-21-XX, 244-22-XX, 244-23-XX, 244-24-XX, 244-25-XX; d. OPTETRAK CR Tibial Inserts, with Product Line Numbers: 200-21-XX, 200-22-XX, 200-23-XX, 200-24-XX, 200-25-XX, 200-26-XX, 200-50-XX, 200-51-XX; e. OPTETRAK CR Tibial Slope + Insert, with Product Line Numbers: 200-56-XX, 200-57-XX, 200-61-XX, 200-62-XX, 200-63-XX, 200-64-XX, 200-65-XX; f. OPTETRAK CR Tibial Slope ++ Insert, with Product Line Numbers: 200-57-XX, 200-71-XX, 200-72-XX, 200-73-XX, 200-74-XX, 200-75-XX; g. OPTETRAK PS Tibial Inserts, with Product Line Numbers: 204-21-XX, 204-22-XX 204-23-XX, 204-24-XX, 204-25-XX, 204-26-XX, 204-50-XX, 204-51-XX; h. OPTETRAK "MOMB" Non-Mod Molded Insert, with Product Line Numbers: 204-91-XX, 204-92-XX, 204-93-XX, 204-94-XX, 204-95-XX; i. OPTETRAK CC Tibial Insert, with Product Line Numbers: 208-21-XX, 208-22-XX, 208-23-XX, 208-24-XX, 208-25-XX, 208-51-XX; j. OPTETRAK B-Series PS Tibial Insert, with Product Line Numbers: 224-21-XX, 224-22-XX, 224-23-XX, 224-24-XX. Affected 510(k) numbers include: K932690, K933494, K932776, K011976, K082022, K933610, K030686, K954208, K010434, K033883. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH GXL 0 DEGREE LINER 28MM SZ E, REF 130-28-25 b. ACUMATCH GXL 0 DEGREE LINER 28MM SZ F, REF 130-28-26 c. ACUMATCH GXL 0 DEGREE LINER 28MM SZ G, REF 130-28-27 d. ACUMATCH GXL 0 DEGREE LINER 28MM SZ H, REF 130-28-28 e. ACUMATCH GXL 0 DEGREE LINER 28MM SZ J, REF 130-28-29 f. ACUMATCH GXL 0 DEGREE LINER 32MM SZ G, REF 130-32-27 g. ACUMATCH GXL 0 DEGREE LINER 32MM SZ H, REF 130-32-28 f. ACUMATCH GXL 0 DEGREE LINER 32MM SZ J, REF 130-32-29 g. ACUMATCH GXL 0 DEGREE LINER 36MM SZ H, REF 130-36-28 h. ACUMATCH GXL 0 DEGREE LINER 36MM SZ J, REF 130-36-29 i. ACUMATCH GXL 0 DEGREE LINER 36MM SZ K, REF 130-36-30 j. ACUMATCH GXL 15 DEG +5 LAT LINER 28MM SZ E, REF 138-28-25 k. ACUMATCH GXL 15 DEG +5 LAT LINER 28MM SZ F, REF 138-28-26 l. ACUMATCH GXL 15 DEG +5 LAT LINER 28MM SZ G, REF 138-28-27 m. ACUMATCH GXL 15 DEG +5 LAT LINER 28MM SZ H, REF 138-28-28 n. ACUMATCH GXL 15 DEG +5 LAT LINER 28MM SZ J, REF 138-28-29 o. ACUMATCH GXL 15 DEG +5 LAT LINER 36MM SZ H, REF 138-36-28 p. ACUMATCH GXL 15 DEG +5 LAT LINER 36MM SZ J, REF 138-36-29 q. ACUMATCH GXL 15 DEG +5 LAT LINER 36MM SZ K, REF 138-36-30 r. ACUMATCH GXL 15 DEG +5 LAT LINER SZG 38MM, REF 138-36-27 s. ACUMATCH GXL 15DEG LINER 28MM SZ D, REF 132-28-24 t. ACUMATCH GXL 15DEG LINER 28MM SZ E, REF 132-28-25 u. ACUMATCH GXL 15DEG LINER 28MM SZ F, REF 132-28-26 v. ACUMATCH GXL 15DEG LINER 28MM SZ G, REF 132-28-27 w. ACUMATCH GXL 15DEG LINER 28MM SZ H, REF 132-28-28 x. ACUMATCH GXL 15DEG LINER 28MM SZ J, REF 132-28-29 y. ACUMATCH GXL 15DEG LINER 28MM SZ K, REF 132-28-30 z. ACUMATCH GXL 15DEG LINER 32MM SZ G, REF 132-32-27 aa. ACUMATCH GXL 15DEG LINER 32MM SZ H, REF 132-32-28 bb. ACUMATCH GXL 15DEG LINER 32MM SZ J, REF 132-32-29 cc. ACUMATCH GXL 15DEG LINER 32MM SZ K, REF 132-32-30 dd.ACUMATCH GXL 15DEG LINER 36MM SZ H, REF 132-36-28 ee. ACUMATCH GXL 15DEG LINER 36MM SZ J, REF 132-36-29 ff. ACUMATCH GXL 15DEG LINER 36MM SZ K, REF 132-36-30 gg. ACUMATCH GXL EXT COV LINER 28MM SZ E, REF 134-28-25 hh. ACUMATCH GXL EXT COV LINER 28MM SZ F, REF 134-28-26 ii. ACUMATCH GXL EXT COV LINER 28MM SZ G, REF 134-28-27 jj. ACUMATCH GXL EXT COV LINER 28MM SZ H, REF 134-28-28 kk. ACUMATCH GXL EXT COV LINER 28MM SZ J, REF 134-28-29 ll. ACUMATCH GXL EXT COV LINER 28MM SZ K, REF 134-28-30 mm. MCS GXL LINER 5/15 DEG 4448X28, REF 104-28-43 nn. MCS GXL LINER 5/15 DEG 5052X28, REF 104-28-44 oo. MCS GXL LINER 5/15 DEG 5458X28, REF 104-28-45 pp. MCS GXL LINER 5/15 DEG 5458X32, REF 104-32-45 qq. MCS GXL LINER 5/15 DEG 6064X32, REF 104-32-46 rr. MCS GXL LINER 5/15 DEG 6064X36, REF 104-36-46 ss. MCS GXL LINER 5/15 DEG 6670X36, REF 104-36-47
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022