28 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Arrow¿ Percutaneous Sheath Introducer Kits The Percutaneous sheath introducer products permit venous or arterial access and device introduction to the central circulation.
FDA Enforcement
Class II
·Terminated·Arrow International Inc·June 11, 2014
Insufflation tubing to be used with varies insufflator units. REF 031200-10; REF 031322-10; REF 031532-10; REF 031622-10
FDA Recall
Terminated
·Karl Storz Endoscopy·Product code NKC·January 9, 2019
DeRoyal Insufflation Tubing sets: 1) REF 28-0206 Insufflation Tubing, Laparoscopic Rx Only 2) REF 28-0214 Hi-Flow Insufflation Tubing Rx Only 3) REF 28-0216 Tubing, Insuf w/.3 Micr Filter Rx Only 4) REF 28-0217 Insufflation Tubing, Laparoscopic Rx Only 5) REF 28-0208 Insufflation Tubing w/Vent Rx Only 6) REF 28-0212H Heated Hi-Flow Insufflation Tubing Rx Only. Used during laparoscopic surgical procedures to aid in the insufflation of the abdomen.
FDA Recall
Terminated
·DeRoyal Industries Inc·Product code NKC·July 15, 2013
STORZ High Flow Insufflation Tubing (with filter), Catalog #20400161S/10 (outer box label), ENDOFLATOR 26-430520-1 also referenced on outer box), individually packaged in a sterile pouch (Catalog #20400161S), 10 pouches per cardboard box. Some of the pouches inside of cardboard box are incorrectly labeled as Catalog number 20400162S, High Flow Insufflation Tubing (with filter) For 26432020-1 THERMOFLATOR. The firm name on the label is Karl Storz Endoscopy-America, Inc., El Segundo, CA.
FDA Recall
Terminated
·Karl Storz Endoscopy·Product code NKC·October 10, 2017
Remington MEDICAL, Automatic Cutting Needle, 18ga (1.3mm) x 20cm, REF NAC-1820M (1)
FDA Enforcement
Class II
·Terminated·Remington Medical, Inc.·January 4, 2023
Various Types, Sterile/Nonsterile Stainless Steel Nonabsorable Surgical Sutures-SS Wire, STL MF 7 HSCX48 1N 18 X2, Catalog #29-6567M2; SS Wire, STL MF 6 HSCX48 1N 18 X6, Catalog #29-6619M6, SS Wire, STL MF 6 K-60 1N 18"X8, Catalog #29-7270M8,SS Wire, STL MF 5 K-60/ B-60 1N18 X7, Catalog #29-9001M7, SS Wire, STL MF 5 K-61 1N 2X30, Catalog # E2-5367M2, SS Wire, STL MF 5 K-60 1N 6X18, Catalog # E29-5652M6, SS Wire, STL MF 6 K-60 1N 4X18, Catalog # E29-7270M4,SS Wire, STL MF 5 K-60 1N 45CM, Catalog # E29-7272B, SS Wire, STL MF 5 K-60 2N 30, Catalog #X-2235, SS Wire, STL MF 0 KC-6 1N 18, Catalog #X-3399.
FDA Recall
Terminated
·Product code GAM·June 6, 2007
Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Remington Medical, Inc., 5830 Meadowridge Court, Alpharetta, GA 30005. Prostate Biopsy Needles shall be single use only and are to be used by a Urologist in a healthcare setting to obtain needle biopsies of the prostate. The needles are compatible with the Bard Magnum biopsy instrument. The needles have an echogenic tip for accurate placement under ultrasound guidance and centimeter markings along the cannula to facilitate depth placement.
FDA Enforcement
Class II
·Terminated·Remington Medical Inc.·October 17, 2012
Neos Vanadium Excavator Part Number 591/0 SCHE
FDA Recall
Terminated
·Sybron Dental Specialties·Product code EKC·November 14, 2008
MicroTox (AMT Item Number/ AMT Description): MTPA-6MBAU / "MicroTox (AMP300/BZO200)+(COC300/THC50)+ (MET300/MOR300) With Cr, Ni, pH, Bl, S.G.", MTPA-6MBAU/ "MicroTox (AMP300/BZO200)+(COC300/THC50)+ (MET300/MOR300) With Cr, Ni, pH, Bl, S.G."
FDA Recall
Terminated
·Ameditech Inc·Product code DKC·August 18, 2020
ImmuTest Drugs of Abuse Cup (AMT Item Number/ AMT Description): IMCA-5AB-W / "ImmuTest Drugs of Abuse Cup AMP1000+BZO300+COC300+OPI2000+THC50 With Cr, Ni, pH, Bl, S.G.", IMC-8BBCE/ "ImmuTest Drugs of Abuse Cup 8 Drug Detection: (COC300/THC50)+AMP1000+BZO300+BUP10+MET500+MTD300+OPI300 NO ADULTERATION", IMCA-8CM5 /"ImmuTest Drugs of Abuse Cup (OXY100/MDMA500)+(PCP25/AMP1000)+COC150+MET500+OPI2000+THC50 with Cr, Ni, pH, Bl, S.G."
FDA Recall
Terminated
·Ameditech Inc·Product code DKC·August 18, 2020
MicroScreen (AMT Item Number/ AMT Description): MSCA-6MBAU/ "MicroScreen AMP300/BZO200/COC300/MET300/OPI300/ THC50 with Cr, Ni, pH, Bl, S.G. "
FDA Recall
Terminated
·Ameditech Inc·Product code DKC·August 18, 2020
Neos Vanadium Excavator Part Number 591/0-6
FDA Recall
Terminated
·Sybron Dental Specialties·Product code EKC·November 14, 2008
Neos Vanadium Excavator Part Number 591/3 SCHE
FDA Recall
Terminated
·Sybron Dental Specialties·Product code EKC·November 14, 2008
Neos Vanadium Excavator Part Number 591/4
FDA Recall
Terminated
·Sybron Dental Specialties·Product code EKC·November 14, 2008
Neos Vanadium Excavator Part Number 591/5 SCHE
FDA Recall
Terminated
·Sybron Dental Specialties·Product code EKC·November 14, 2008
Neos Vanadium Excavator Part Number 591/2
FDA Recall
Terminated
·Sybron Dental Specialties·Product code EKC·November 14, 2008
First Check 1 Panel Drug Cup: (THC); AMT Item Number 990400B
FDA Recall
Terminated
·Ameditech Inc·Product code DKC·August 18, 2020
Neos Vanadium Excavator Part Number 591/0
FDA Recall
Terminated
·Sybron Dental Specialties·Product code EKC·November 14, 2008
Neos Vanadium Excavator Part Number 591/1
FDA Recall
Terminated
·Sybron Dental Specialties·Product code EKC·November 14, 2008
ProScreen" Drugs of Abuse Test (AMT Item/ AMT Description): PSD-6MB/ "ProScreen" Drugs of Abuse Test (MET1000/OPI2000)+AMP+BZO+COC+THC", PSD-6MTDBO-300 /"ProScreen" Drugs of Abuse Test (COC/THC)+BZO+MTD+OPI300+OXY", PSCUP-5M-W/ ProScreen" Drugs of Abuse Cup AMP/COC/MET1000/OPI2000/THC), PSD-10MOB "ProScreen" Drugs of Abuse Test (COC/THC)+(MET1000/OPI2000)+(OXY/ MDMA)+AMP+BZO+BUP+MTD", PSD-5M / "ProScreen" Drugs of Abuse Test AMP/COC/MET1000/OPI2000/THC", PSCUPA-10OM / ProScreen" Drugs of Abuse Cup (COC/THC)+(MET1000/OPI2000)+(OXY/ MDMA) +(PCP/AMP)+BAR+BZO
FDA Recall
Terminated
·Ameditech Inc·Product code DKC·August 18, 2020