24 results
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15ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM FEMORAL COMPONENT¿ N-K FLX GSM POR FEM SZ 2 RT N-K FLX GSM POR FEM SZ 3 LT N-K FLX GSM POR FEM SZ 4 LT N-K FLX GSM POR FEM SZ 4 RT N-K FLX GSM POR FEM SZ 5 LT N-K FLX GSM POR FEM SZ 5 RT Components with CSTi porous coating are indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD).
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 21, 2018
Passport 2/Passport 2 LT Vital Signs Monitor. Multi-parameter patient monitoring system.
FDA Recall
Terminated
·Datascope Corp·Product code MSX·April 5, 2004
GYRUS ACMI, dissector PlasmaKnife" , REF 7035-3005, Rx only, STERILE R, CE 0344, 161416-CA, MANUFACTURED FOR; GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01722-2104, USA, EC REP, GYRUS MEDICAL LIMITED, FORTRAN ROAD, ST. MELLONS, CARDIFF, CF3 0LT, UK
FDA Recall
Terminated
·Gyrus Acmi, Incorporated·Product code GEI·August 6, 2010
LAPAROSCOPY CHOLE PACK - (6) TOWELS ABSORBENT 15" X 20" LIF (1) MAYO STAND COVER REINFORCED L/F (1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF (1) SURGICAL BLADE #11 CARBON STEEL (1) TUR Y SET, 2LEAD L/F (4) DRAPE UTILITY WITH TAPE LIF (1) TROCAR ENDO. XCEL DILATING TIP 5mm (K5LT) (1) ULTRA VERES NEEDLE 120mm (1) NEEDLE & BLADE COUNTER 20C FOAM/MAG LIF (1) DRAPE LAP. ABDOM. WITH POUCH 102" X 122" X 78" (2) DRAPE SHEET 41" X 58" SMS (2) GOWN IMPERVIOUS REINFORCED X-LARGE SMS LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD L/F (5) LAP SPONGE PREWASH XRD LIF (1 ) DRAPE LASER CAMERA W/EL. 6" X 96" LIF (1) TUBE SUCTION CONNECT. 3/16" X 12' LIF (1) TROCAR ENDOPATH XCEL DILATING TIP 11mm (K1 1LT) (1) TUBING INSUFLATION SET W/0 RING ADAPTOR LIF (1) SURGICAL DURAPREP SOLUTION 26ML LIF (1) TABLE COVER REINFORCED 50" X 90" LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
LAPAROSCOPY CHOLE PACK - (6) TOWELS ABSORBENT 15" X 20" LIF (1) MAYO STAND COVER REINFORCED L/F (1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF (1) SURGICAL BLADE #11 CARBON STEEL (1) TUR Y SET, 2LEAD L/F (4) DRAPE UTILITY WITH TAPE LIF (1) TROCAR ENDO. XCEL DILATING TIP 5mm (K5LT) (1) ULTRA VERES NEEDLE 120mm (1) NEEDLE & BLADE COUNTER 20C FOAM/MAG LIF (1) DRAPE LAP. ABDOM. WITH POUCH 102" X 122" X 78" (2) DRAPE SHEET 41" X 58" SMS (2) GOWN IMPERVIOUS REINFORCED X-LARGE SMS LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD L/F (5) LAP SPONGE PREWASH XRD LIF (1 ) DRAPE LASER CAMERA W/EL. 6" X 96" LIF (1) TUBE SUCTION CONNECT. 3/16" X 12' LIF (1) TROCAR ENDOPATH XCEL DILATING TIP 11mm (K1 1LT) (1) TUBING INSUFLATION SET W/0 RING ADAPTOR LIF (1) SURGICAL DURAPREP SOLUTION 26ML LIF (1) TABLE COVER REINFORCED 50" X 90" LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code FDE·May 20, 2014
GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENT NONPOROUS¿ N-K FLX GSF NP FEM SZ 0 RT N-K FLX GSF NP FEM SZ 4 LT N-K FLX GSF NP FEM SZ 4 RT Components with CSTi porous coating are indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD).
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 21, 2018
Synchron Systems Drug Calibrator 1 (Carbamaxepine, Phenobarbitol, Phentoin, Theophylline, and Valproic Acid).
FDA Recall
Terminated
·Beckman Coulter Inc·Product code KLT·June 11, 2003
VITROS Chemistry Products CRBM Slides, REF 889 2382, IVD -- Ortho-Clinical Diagnostics, Inc. For in vitro diagnostic use only. VITROS Chemistry Products CRBM Slides quantitatively measure carbamazepine (CRBM) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code KLT·March 5, 2014
Vitros Chemistry CRBM Slides, REF 889 2382. There are 90 slides per box. For in vitro diagnostic use. Firm on label: Ortho-Clinical Diagnostics, Inc., Rochester, NY 14626.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code KLT·May 26, 2005
VITROS Chemistry Products CRBM Slides packaged as 90 slides/pack catalog number 8892382
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code KLT·June 12, 2013
Centurion-Pelvic PE120 LARGE/MEDIUM PELVIC TRAY PE2200 PELVIC EXAM TRAY PE2200 PELVIC EXAM TRAY PE2400 PELVIC EXAM TRAY PE2515 SMALL GYN EXAM TRAY PE2515 SMALL GYN EXAM TRAY PE2610 PELVIC EXAM TRAY PE2700 ULTRASOUND TRAY PE2700 ULTRASOUND TRAY PE2820 VAG/VIRGIN VAG EXAM TRAY PE2835 PELVIC EXAM TRAY PE2835 PELVIC EXAM TRAY PE2905 HSG TRAY PE2955 7PELVIC EXAM TRAY PE2965 DISPOSABLE PELVIC EXAM TRAY PE2965 DISPOSABLE PELVIC EXAM TRAY PE3125 PELVIC EXAM TRAY PE3195 PELVIC EXAM TRAY PE3285 PELVIC EXAM TRAY PE3360 PELVIC EXAM TRAY W/LIGHT PE3375 PELVIC EXAM TRAY PE3400 MEDIUM GYN EXAM TRAY PE3475 IUD TRAY PE3585 MEDIUM/LARGE PELVIC EXAM TRAY PE860 VAGINAL BLEEDER KIT
FDA Recall
Terminated
·Centurion Medical Products Corporation·Product code MLT·December 11, 2019
Bravo pH Monitoring capsule, UPC 7290101361695 (FGS# 0312) and UPC 7290101361688 (FGS# 0313). Product Usage: The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children form 4 years of age. The Bravo pH Capsule can be attached following either endoscopy or manometry.
FDA Recall
Terminated
·Given Imaging Ltd.·Product code LLT·January 11, 2012
Centurion-Vaginal Speculum VS2000LST STERILE ER VAGINAL SPECULUM W/LIGHT
FDA Recall
Terminated
·Centurion Medical Products Corporation·Product code MLT·December 11, 2019
Package Insert for TDx/TDxFLx and TDxFLx Carbamazepine Reagents, REF 9515, item number 69-5121/R4; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD/GPRD·Product code KLT·November 17, 2003
Centurion- Pelvic Exam Kits DYNDE1037 PELVIC EXAM TRAY,UNIVERSITY H 2019032090 DYNDE1037 PELVIC EXAM TRAY,UNIVERSITY H 2018091790
FDA Recall
Terminated
·Centurion Medical Products Corporation·Product code MLT·December 11, 2019
OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (tibia)
FDA Recall
Terminated
·Merete Medical GmbH Alt-Lankwitz 102 Berlin Germany·Product code HSB·September 18, 2020
OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (femur)
FDA Recall
Terminated
·Merete Medical GmbH Alt-Lankwitz 102 Berlin Germany·Product code HSB·September 18, 2020
Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only
FDA Recall
Terminated
·Merete Medical GmbH Alt-Lankwitz 102 Berlin Germany·Product code JDR·January 18, 2022
OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (humerus)
FDA Recall
Terminated
·Merete Medical GmbH Alt-Lankwitz 102 Berlin Germany·Product code HSB·September 18, 2020
OsteoBridge Intremedullary Knee Arthrodesis (IKA) nails
FDA Recall
Terminated
·Merete Medical GmbH Alt-Lankwitz 102 Berlin Germany·Product code HSB·September 18, 2020