10,000 results
·
14ms
·
Sources: EU EUDAMED, US FDA
TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 RIGHT Catalog # 5541-A-202 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA to address distal femoral defects. (See attached IFU (IFU_Triathlon Total Knee_QIN 4376 Rev AB).
FDA Enforcement
Class II
·Terminated·Howmedica Osteonics Corp.·October 9, 2019
2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORTABLE CRM; b) 209031, Product Description: PROGRAMMER 209031 PORTABLE CRM; c) 2090AA, Product Description: PROGRAMMER 2090AA PORTABLE CRM; d) 2090AA4, Product Description: 2090AA4 PROGRAMMER-PORTABLE CRM; e) 2090AC, Product Description: SFTWR 2090AC PROGRAMMER-PORTABLE CRM W/; f) 2090AM, Product Description: PROGRAMMER CARELINK HONG KONG ASIA; g) 2090CHEN, Product Description: PRGM 2090CHEN PKG-ASSY PROGRAMMER 2090; h) 2090CHFR, Product Description: PRGM 2090CHFR PKG-ASSY PROGRAMMER 2090; i) 2090CL, Product Description: PROGRAMMER 2090CL INTL-JAPAN MKT; j) 2090EN, Product Description: PRGM 2090EN PKG-ASSY PROGRAMMER 2090 UK; k) 2090FR, Product Description: PRGM 2090FR PKG-ASSY PROGRAMMER 2090 IN; l) 2090LDEN, Product Description: PRGM 2090LDEN PROGRAMMER-PORTABLE LOANE; m) 2090NL, Product Description: PRGM 2090NL PKG-ASSY PROGRAMMER 2090 IN; n) 2090W, Product Description: PROGRAMMER 2090W TELEMETRY C; o) 2090WCHDE, Product Description: PROGRAMMER 2090WCHDE SWISS-GERMAN; p) 2090WCHEN, Product Description: PROGRAMMER 2090WCHEN SWISS-ENGLISH; q) 2090WCHFR, Product Description: PROGRAMMER 2090WCHFR SWISS-FRENCH; r) 2090WDE, Product Description: PROGRAMMER 2090WDE GERMAN MKT; s) 2090WFR, Product Description: PROGRAMMER 2090WFR FRENCH MKT; t) 2090WLD, Product Description: PROG 2090WLD ALL LANGUAGES W/ANALYZER; u) 2090WNL, Product Description: PROGRAMMER 2090WNL NETHERLANDS MKT
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·September 25, 2024
Medline Sterile Oncology Port Access Tray, Item #DYNDC2239, 20 sterile kits per case, containing Ethicon Biopatch Protective Disk with CHG, Disk with Chlorhexidine Gluconate (CHG), DRSG Biopatch 1IN NS, VPN: 10150;
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·March 1, 2023
Sterile Procedural Trays, labeled as the following: a. SPINAL b. SPINE CDS c. TOTAL ORTHO CDS d. TOTAL KNEE CDS e. CDS HIP-LF f. KNEE TOTAL PACK-LF g. EXTREMITY CDS h. SHOULDER ARTHRO CDS i. GLENNON EXTREMITY CDS j. KNEE ARTHROSCOPY k. TOTAL KNEE l. TOTAL HIP REPLACEMENT m. TOTAL KNEE CDS-LF n. TOTAL SHOULDER CDS-LF o. TOTAL KNEE CDS-3 p. TOTAL HIP CDS-3 q. LOWER EXTREMITY CDS-LF r. TOTAL HIP-LF s. TOTAL HIP/KNEE CDS t. SPINE PROCEDURE u. OPEN HEART v. LAMI w. UPPER EXTREMITY CDS x. LOWER EXTREMITY CDS y. KNEE ARTHROSCOPY CDS z. KNEE ARTHROSCOPY CDS-LF aa. SHOULDER CDS-LF bb. PODIATRY CDS cc. KNEE ARTHROSCOPY CDS dd. SHOULDER ARTHROSCOPY CDS ee. ACL CDS ff. CRANIOTOMY CDS gg. TOTAL KNEE CDS hh. TOTAL KNEE ii. TOTAL HIP CDS jj. NEW LONDON TOTAL KNEE CDS kk. TRAUMA CDS-LF ll. TOTAL JOINT CDS mm. CRANIOTOMY CDS-1 nn. SHOULDER CDS-1 oo. SPINE CDS-1 pp. TOTAL KNEE CDS-1 qq. TOTAL HIP CDS-1 rr. LOWER EXTREMITY CDS-2 ss. HAND CDS-2 tt. KNEE ARTHROSCOPY CDS-2 uu. HAND CDS vv. BACK CDS ww. FRACTURE TABLE CDS xx. ORTHO OP CDS yy. ARTHROSCOPY CDS zz. ORTHO MINOR CDS aaa. TOTAL JOINT KNEE CDS bbb. TOTAL JOINT HIP CDS ccc. SHOULDER CDS-LF ddd. ZALE CRANIOTOMY CDS eee. ZALE TOTAL KNEE CDS fff. ZALE EXTREMITY CDS ggg. OPEN SHOULDER CDS hhh. LOWER EXTREMITY CDS iii. FHT TOTAL HIP jjj. FHT TOTAL KNEE RPLCMNT kkk. TOTAL HIP CDS lll. TOTAL KNEE CDS mmm. CCOC ACL-LF nnn. CCOC SPINAL FUSION ooo. CCOC MAJOR EXTREMITY ppp. EXTREMITY CDS qqq. PODIATRY CDS rrr. SHOULDER CDS sss. DISTAL LEG CDS ttt. HIP NAILING CDS uuu. SHOULDER CDS vvv. TOTAL HIP CDS www. UPPER EXTREMITY CDS xxx. BASIC ORTHO CDS yyy. TOTAL HIP PROCEDURE zzz. TOTAL JOINT CDS-LF aaaa. SHOULDER CDS-LF bbbb. HAND CDS-LF cccc. KNEE ARTHROSCOPY CDS-LF dddd. TOTAL JOINT eeee. UPPER EXTREMITY CDS ffff. LOWER EXTREMITY CDS gggg. GENERAL ORTHO CDS hhhh. ARTHROSCOPY CDS iiii. KNEE ARTHROSCOPY CDS jjjj. SHOULDER ARTHROSCOPY CDS kkkk. KNEE ARTHROSCOPY CDS llll. TOTAL ORTHO CDS mmmm. GROTH LOWER EXTREMITY CDS nnnn. HIP TOTAL PACK-ANTERIOR oooo. PRAIRIE STAR SPINE CDS pppp. 4TH FLOOR SHOULDER ARTHROSCOPY qqqq. FOOT & ANKLE CDS-LF rrrr. LAMI MICRODISC-LF ssss. HIP PINNING CDS-LF tttt. KNEE ARTHROSCOPY CDS-LF uuuu. UPPER EXTREMITY CDS-LF vvvv. SPINE CDS-LF wwww. SPINE CDS-LF xxxx. LOWER EXTREMITY/ELBOW CDS yyyy. HAND CDS zzzz. KNEE ARTHROSCOPY CDS aaaaa. SPINE CDS bbbbb. TOTAL HIP CDS ccccc. KNEE ARTHROSCOPY CDS ddddd. HAND CDS eeeee. TOTAL KNEE CDS-LF fffff. SPINE MODULE CDS ggggg. UPPER EXTREMITY CDS-LF hhhhh. TOTAL JOINT CDS iiiii. TOTAL JOINT CDS jjjjj. ORTHO TRAUMA CDS kkkkk. ACF CDS lllll. CRANIOTOMY CDS mmmmm. TOTAL JOINT CDS nnnnn. ARTHROSCOPY CDS ooooo. EXTREMITY CDS ppppp. PODIATRY CDS qqqqq. LAMINECTOMY CDS rrrrr. EXTREMITY CDS sssss. TOTAL KNEE CDS ttttt. TOTAL HIP CDS uuuuu. TOTAL KNEE vvvvv. ANTERIOR HIP wwwww. HAND WRIST FOREARM xxxxx. LOWER EXTREMITY yyyyy. TOTAL HIP zzzzz. TOTAL KNEE aaaaaa. SHOULDER ARTHROSCOPY bbbbbb. SHOULDER ARTHROSCOPY PK cccccc. LUMBAR LAMINECTOMY PACK dddddd. CRANIOTOMY PACK-LF eeeeee. OPEN SHOULDER PACK-LF ffffff. TOTAL HIP PACK-LF gggggg. TOTAL KNEE PACK-LF hhhhhh. SHOULDER ARTHROSCOPY PACK-LF iiiiii. EXTREMITY PACK jjjjjj. CLOSED HEART PEDS PACK kkkkkk. ORTHO MINOR PACK-LF llllll. FRACTURE TABLE PACK-LF mmmmmm. HAND - EDOC PACK-LF nnnnnn. FOOT LV - EDOC PACK-LF oooooo. SHOULDER - EDOC PACK-LF pppppp. FOOT ANKLE PACK-LF qqqqqq. OPEN HEART TRAY rrrrrr. SHOULDER PACK-LF ssssss. ROCKVILLE ASC EXTREMITY PACK tttttt. NEURO SPINE DRH PACK-LF uuuuuu. DRH ORTHOPEDIC I AND D PACK-LF vvvvvv. KNEE ARTHROSCOPY MIOSH PACK-LF wwwwww. HAND AND FOOT PACK-LF xxxxxx. SPINE BUNDLE PACK yyyyyy. MINOR ORTHOPEDIC PACK-LF zzzzzz. FEM POP PACK-LF aaaaaaa. LAMINECTOMY PACK-LF bbbbbbb. CRANIOTOMY PACK-LF ccccccc. MAJOR ORTHO PACK-LF ddddddd. HAND WRIST PACK-LF eeeeeee. TOSH PODIATRY PACK-LF fffffff. TOTAL HIP ARTHROPLASTY PACK-LF ggggggg. TOSH UPPER EXTREM MIOSH PK-LF hhhhhhh. OPEN HEART CHILDRENS PACK-LF iiiiiii. CRANIOTOMY PACK-LF jjjjjjj. SPINE HARPER PACK-LF kkkkkkk. CRANIOTOMY
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·February 15, 2023
Otto Bock Aerial and Aerial Active Wheelchair Cushions. Material numbers: SK757 476C00=SK701, 476C00=SK702, 476C00=SK703, 476C00=SK704, 476C00=SK705, 476C00=SK706, 476C00=SK707, The following material numbers were not distributed within the US: 476C00=SK751, 476C00=SK752, 476C00=SK753, 476C00=SK754, 476C00=SK755, 476C00=SK756, 476C00= SK757.
FDA Enforcement
Class II
·Terminated·Bock,Otto,Orthopedic Ind,Inc·March 26, 2014
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Generator Refurbished PG Catalog Number: 12740000D UPN: H78712740000D0 (2) Solero Generator Refurbished US PG Catalog Number: 12740000USD ;UPN: H78712740000USD0
FDA Enforcement
Class II
·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·June 12, 2019
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generator PG (1) Catalog Number:12740000 UPN: H78712740000 (2) Solero Generator US PG Catalog Number: 12740000US UPN: H78712740000US0 (3) Solero Generator Service Loaner PG Catalog No: 12740000L UPN: H78712740000L0 (4) Solero Generator Service Loaner US PG Catalog Number: 12740000USL UPN: H78712740000USL0
FDA Enforcement
Class II
·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·June 12, 2019
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 19cm PG Catalog Number: 700106002 UPN: H7877001060020 (2)Solero Applicator 19cm PG US Catalog Number:700106002US UPN: H787700106002US0 Product Usage: The Solero Microwave Tissue Ablation (MTA) System and accessories are indicated for the ablation of soft tissue during open procedures. The Solero MTA System is not intended for cardiac use.
FDA Enforcement
Class II
·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·June 12, 2019
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 29cm PG Catalog Number:700106003 UPN: H7877001060030 (2)Solero Applicator 29cm PG US Catalog Number:700106003US UPN:H787700106003US0 Product Usage: The Solero Microwave Tissue Ablation (MTA) System and accessories are indicated for the ablation of soft tissue during open procedures. The Solero MTA System is not intended for cardiac use.
FDA Enforcement
Class II
·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·June 12, 2019
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Applicator 14cm PG Catalog Number: 700106001 UPN:H7877001060010; (2)Solero Applicator 14cm PG US Catalog Number:700106001US UPN: H787700106001US0 Product Usage: The Solero Microwave Tissue Ablation (MTA) System and accessories are indicated for the ablation of soft tissue during open procedures. The Solero MTA System is not intended for cardiac use.
FDA Enforcement
Class II
·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·June 12, 2019
BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED PG UPN: H965440210 Catalog Number: 44-021 Box of 1 Port - Product Usage - Long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal.
FDA Enforcement
Class II
·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·October 17, 2018
Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management and/or Invasive Pressure Monitoring systems.
FDA Enforcement
Class II
·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·April 25, 2018
Cloth electrodes with Carbon construction: P/N 201-1231, Cat Nos.: 201-123, 202-454, 203-118, 203-342, 203-454, 203-493, 203-672, 400-877, and 400-877-BJC, 2" x 2" Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1241, Cat Nos.: 201-124, 202-455, 203-340, 203-674, and 400-872, 2" Round Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1251, Cat Nos.: 201-138, 202-276, 202-456, 203-336, 203-680, and 400-879, 3" Round Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1381, Cat Nos.: 201-126, 203-678, and 400-856, 2" x 3.5" Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1501, Cat Nos.: 201-150 and 400-863, 1.25" Round Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1521, Cat No. 400-852, 3 x 5 Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1541, Cat Nos.:201-154 and 400-865 1.5 x 2.5 Oval Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 Cutaneous electrode.
FDA Enforcement
Class II
·Terminated·NAImco Inc dba Richmar Inc·February 20, 2013
Cloth electrodes with Silver-Carbon construction: P/N 202-9231, Cat No. 400-899, 2" x 2" Electrode, Cloth, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9241, Cat No. 400-895, 2" Round Electrode, Cloth, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9381, Cat No. 400-889, 2" x 3.5" Electrode, Cloth AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9501, Cat No. 202-9501, 1.25" Round Electrode, Cloth AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 400-8991, Cat Nos.: 400-877T and 400-899T, 2" x 2.25" Electrode, Cloth, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010. Cutaneous electrode.
FDA Enforcement
Class II
·Terminated·NAImco Inc dba Richmar Inc·February 20, 2013
Foam electrodes with Silver-Carbon construction: P/N 202-9271, Cat No. 400-898, 2" x 2" Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9281, Cat No. 202-9281, 2" Round Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9251, Cat No. 400-893, 3" Round Electrode, Foam AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9291, Cat No. 400-892, 3" Round Electrode, Foam AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9371, Cat No. 400-888, 2" x 3.5" Electrode, Foam AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9491, Cat No. 400-869, 1.25" Round Electrode, Foam AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9511, Cat No. 400-853, 3" x 5" Electrode, Foam AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 300-1541, Cat No. 300-154, 2" x 2.25" Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 300-1561, Cat No. 300-156, 2" Round Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 300-1611, Cat No. 300-161, 4" x 2.25" Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010, 22818 P/N 300-1631, Cat No. 300-163, 3" Round Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 400-8701, Cat No. 400-870, 2" x 4" Oval Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010. Cutaneous electrode.
FDA Enforcement
Class II
·Terminated·NAImco Inc dba Richmar Inc·February 20, 2013
Foam Electrodes with Carbon construction: P/N 201-1261, Cat Nos.: 201-126, 203-678, and 400-856, 1.5" x 3.5" Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1271, Cat Nos.: 201-127, 202-093, 203-483, 203-565, 203-673, and 400-873, 2" x 2" Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1281, Cat Nos.: 201-128, 202-277, 203-675, and 400-873, 2" Round Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1291, Cat Nos.: 201-129, 203-677, and 400-882, 3" Round Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1301, Cat Nos.: 201-130, 203-679, and 400-855, 1.5" x 3.5" Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1371, Cat Nos.: 201-137, 202-278, 203-484, 203-681, and 400-880, 2" x 3.5" Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-5671, Cat No. 202-567, 2" x 2" Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010. Cutaneous electrode.
FDA Enforcement
Class II
·Terminated·NAImco Inc dba Richmar Inc·February 20, 2013
Vortex MEDICAL AngioVac Circuit, REF/UPN VTX3100, STERILE, Rx Only, Single Use Only -- The AngioVac Circuit and AngioVac Circuit Pack are designed to be used with the AngioVac Cannula.
FDA Enforcement
Class II
·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·June 1, 2016
AngioVac Circuit Pack (Tandem Packs), REF/Catalog No. 25-187, UPN H965251870, STERILE, Rx Only, Single Use Only -- The AngioVac Circuit and AngioVac Circuit Pack are designed to be used with the AngioVac Cannula.
FDA Enforcement
Class II
·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·June 1, 2016
NAMIC Fluid Delivery Set - 72" (183cm) UPN H965913000051, Catalog 91300005
FDA Enforcement
Class II
·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·April 26, 2017
BioFlo PICC with ENDEXO and PASV Valve Technology Maximal Barrier Nursing Kit - UPN # H965750191/Catalog No:75-019 The BioFlo PICCs with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; and for power injection of contrast media
FDA Enforcement
Class II
·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·December 14, 2016