30 results
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7ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Star 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ BL(Blue)/ DB(Sky Blue)/ PL(Purple)/ RD(Red)
FDA Enforcement
Class II
·Ongoing·Nova Ortho-Med Inc·December 30, 2020
AUTO REF/KERATOMETER ARK-1s
FDA Enforcement
Class II
·Terminated·Nidek Inc.·April 18, 2018
Verso Shoulder Forked Retractor (Comprehensive Instrumentation 2 Prong Retractor) Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·March 16, 2016
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229035A Model:VST60DF
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular Us Sales, Llc·July 3, 2019
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229000A Model: VST60SF AIM
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular Us Sales, Llc·July 3, 2019
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811901 Model: VLT600SF AIM STP
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular Us Sales, Llc·July 3, 2019
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229034A Model: VST60SF
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular Us Sales, Llc·July 3, 2019
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229001A Model: VST60DF AIM
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular Us Sales, Llc·July 3, 2019
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568812910 Model: VLT400SF STP
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular Us Sales, Llc·July 3, 2019
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229036A Model:VST66SF
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular Us Sales, Llc·July 3, 2019
Karma Flexx Wheelchair Manual Wheelchair.
FDA Enforcement
Class II
·Terminated·Karman Healthcare Inc·March 9, 2016
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229003A Model: VST66DF AIM
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular Us Sales, Llc·July 3, 2019
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229002A Model: VST66SF AIM
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular Us Sales, Llc·July 3, 2019
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811910 Model:VLT600SF STP
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular Us Sales, Llc·July 3, 2019
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229037A Model: VST66DF
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular Us Sales, Llc·July 3, 2019
GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603, Product Code KSA; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
FDA Enforcement
Class II
·Ongoing·GE Medical Systems Information Technologies Inc·June 3, 2026
ARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kit for High Volume Infusions; Product Codes: AK-22142-CDC, AK-22142-F, AK-25142-CDC, AK-25142-F; Exp. Dates Feb 2018 - Nov 2018
FDA Enforcement
Class II
·Terminated·Arrow International Inc·February 28, 2018
4 In. Flat Responder Emergency Trauma Dressing part number 30-0171, packaged in kits labeled as follows: a) M-FAK Mini First Aid Kit; Kit Product Code: 80-0890 b) M-FAK Mini First Aid Kit, with Bleeding Control Dressing; Kit Product Code: 80-0891 c) M-FAK Mini First Aid Kit, Advance; Kit Product Code: 80-0892 d) M-FAK Mini First Aid Kit, Basic; Kit Product Code: 80-0913 e) M-FAK Mini First Aid Kit; Kit Product Code: 80-0914 f) Trauma and First Aid Kit; Kit Product Code: 80-0947 g) Trauma and First Aid Kit; Kit Product Code: 80-0948 h) Trauma and First Aid Kit; Kit Product Code: 80-1047 i) Trauma and First Aid Kit Hard Case, Class B, with Bleeding Control Dressing; Kit Product Code: 80-1048 j) Micro individual first aid kit; Kit Product Code: 82-0002 k) Individual Aid Kit; Kit Product Code: 85-0404 l) KMBR HII Kit; Kit Product Code: 85-0757 m) Compact Officer Response Emergency Kit; Kit Product Code: 85-0834 n) Public Access Bleeding Control Twin Pack, Basic; Kit Product Code: 80-0951 o) Public Access Bleeding Control Twin Pack, Intermediate; Kit Product Code: 80-0952 p) Public Access Bleeding Control Twin Pack, Advanced BCD; Kit Product Code: 80-0953 q) Trauma and First Aid Kit; Kit Product Code: 80-1033 r) Trauma and First Aid Kit Hard Case; Kit Product Code: 80-1034 s) Tactical Quick Reaction Individual first aid kit; Kit Product Code: 85-1128 t) M-FAK Kit with S-Rolled Gauze; Kit Product Code: 85-1502 u) Public access individual bleeding control kit; Kit Product Code: 85-1574 v) Emergency Trauma Bleeding control pack; Kit Product Code: 85-1583 w) Bleeding control Kit; Kit Product Code: 85-1759 x) TORK Kit; Kit Product Code: 85-1907 y) Black scout survival IFAK individual first aid kit; Kit Product Code: 85-1942 z) Texas water first aid kit; Kit Product Code: 85-1953 aa) Crisis Ki; Kit Product Code: 85-1970 ab) ALE IFAK individual first aid kit; Kit Product Code: 85-2150 ac) RACH regional advisory council hemorrhage kit; Kit Product Code: 85-2176 ad) Triad Medical's SRAK student response aid kit; Kit Product Code: 85-2327 ae) ODIN medical EMT kit; Kit Product Code: 85-2425 af) ODIN medical AEMT kit; Kit Product Code: 85-2426 ag) Henry Schein public access individual bleeding control kit; Kit Product Code: 85-2430 ah) Henry Schein public access individual bleeding control kit; Kit Product Code: 85-2432 ai) Warrior Poet society Public access individual bleeding control kit; Kit Product Code: 85-2539 aj) Spec Train Compact Carry kit; Kit Product Code: 85-2833 ak) Belfast FD resupply kit; Kit Product Code: 85-2886 al) Trauma and First Aid Kit; Kit Product Code: 80-1045 am) Trauma and First Aid Kit Hard Case Class A, with Bleeding Control Dressing; Kit Product Code: 80-1046 an) M-FAK Kit; Kit Product Code: 85-2920 ao) IFAK individual first aid kit; Kit Product Code: 85-3022 ap) Bleeding control kit; Kit Product Code: 85-3046 aq) Individual first aid kit allegiance holster company; Kit Product Code: 85-3050 ar) RAC-PAK; Kit Product Code: 85-3052 as) Bleeding control E.F.A.K enhanced first aid kit; Kit Product Code: 85-3067 at) Bleeding control E.F.A.K enhanced first aid kit; Kit Product Code: 85-3068 au) Bleeding control E.F.A.K enhanced first aid kit; Kit Product Code: 85-3069 av) Task Force 6 resupply kit; Kit Product Code: 85-3078 aw) PABC Kit; Kit Product Code: 85-3082 ax) MCC IFAK Small Supply Kit; Kit Product Code: 85-3084 ay) MCC IFAK Large Supply Kit; Kit Product Code: 85-3085
FDA Enforcement
Class II
·Terminated·North American Rescue LLC.·October 7, 2020
GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
FDA Enforcement
Class II
·Ongoing·GE Medical Systems Information Technologies Inc·June 3, 2026
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811961 Model: VLT600DF AIM STP
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular Us Sales, Llc·July 3, 2019