19 results
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14ms
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Sources: EU EUDAMED, US FDA
Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) ARROWgard Blue(R) Catheter Product Usage: The multiple-lumen catheter permits venous access to central circulation.
FDA Enforcement
Class I
·Terminated·Arrow International Inc·July 4, 2012
Centurion-_General Surgery Trays DYNDA1127A RADIOLOGY CUT DOWN TRAY #1 DYNDA1178 ICIO TRAY DYNDA1183 AUXILARY TOWEL PACK DYNDA1223 CUSTOM PREP CUP KIT DYNDA1223 CUSTOM PREP CUP KIT DYNDA1246A CIRCUMCISION PACK DYNDA1349A CIRCUMCISION TRAY DYNDA1388 STERILE EK DOUBLE PACK DYNDA1615 STERILE BARRIER KIT DYNDA1615 STERILE BARRIER KIT DYNDA1628 VAG DELIVERY ACCESSORY PACK DYNDA1706A CIRCUMCISION TRAY W/OUT CLAMP DYNDA1843A DISPOSABLE SUTURE TRAY FGS DYNDA1843A DISPOSABLE SUTURE TRAY FGS DYNDA1861 IR KIT DYNDA1904 PREP TRAY DYNDA2076 VEIN PROCEDURE KIT DYNDA2201 SMALL BOWL KIT DYNDA2241 CIRCUMCISION TRAY DYNDA2271 CIRCUMCISION TRAY DYNDA2361 HYSTERO PACK - RADIOLOGY WEILER DYNDA2361 HYSTERO PACK - RADIOLOGY WEILER DYNDA2418 MINOR PROCEDURE TRAY DYNDA2498 STERILE UNIVERSAL KIT
FDA Enforcement
Class II
·Terminated·Centurion Medical Products Corporation·February 12, 2020
Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #: Tl0600 ~ MMP3100CHA04 T10491 MIMP3100CHA04 T12230 M2M1P3100CHA04 T15752 ~MMP3100CHA04 T15949 ~MMP3100CHA04 T17238 MMP3100CHA04 T9954 MMP3100CHA04 T9955 MMP3100CHA04 T8468 MMP3100CHA04 T11506 MMP3100CHA13 T10281 MMP3100CHA04 T8044 ~MMP3100CHA04 T17203 87-4 20-00980 T8177 ~ MMP3100CHA04 T16934 MMP3100CHA62 Tll340 SHP9109.00010 T8043 ~ MMP3100CHA04 T17321 MMPP3100CHA04 T15311 GG920010029 T1 7650 255000110 T8143 803-t 1-103 Tl4384 EK-00200690 T1666t XEB227242 T9316 MIMP3100CHA04 Tl3642 500325 T10753 ~MMP3100CH04 T9348 ~ MMP3100CHA04 T13480 MMP3100CHA042 T10243 ~MIMP3001CHA08 Tll209 ~ MMP300CHA12 Tl0861 MMP3100CHA04 T16427 MMP3100CHA04 T9894 :-. MMP3100CHA04 T12861 MMP3100CHA\041 T8088 2002CUPI T1661 1 T16611 Standard Offset Cup Impactors are handheld, reusable surgical instruments used to position and seat acetabular cups into the reamed acetabulum during hip joint replacement surgery. They are equipped with a suitable connection system to the acetabular cup (e.g. a thread) and can be supplied with a fixed or removable shock absorber. A hammer is used to deliver the necessary impact to an anvil (or impactor disc) at the rear end of the instrument.
FDA Enforcement
Class I
·Terminated·Greatbatch Medical·December 7, 2016
Power Processor 1K Stockyard. The Power Processor performs all pre-analytical sample tube preparation.
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·November 1, 2017
STAGE-1¿ RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit; Catalog Number: S2437-01-1K
FDA Enforcement
Class III
·Terminated·Keystone Dental Inc·April 4, 2018
Volt Resistance Frostie Heated Gloves (All sizes) Deep penetrating heat garment and wraps
FDA Enforcement
Class II
·Terminated·2k Innovations Inc.·April 19, 2017
Volt Resistance Heated Slipper Gray (All sizes) Deep penetrating heat garment and wraps
FDA Enforcement
Class II
·Terminated·2k Innovations Inc.·April 19, 2017
Volt Resistance Heated Therapy Knee Wrap Deep penetrating heat garment and wraps
FDA Enforcement
Class II
·Terminated·2k Innovations Inc.·April 19, 2017
Volt Resistance Heated Slipper Black (All sizes) Deep penetrating heat garment and wraps
FDA Enforcement
Class II
·Terminated·2k Innovations Inc.·April 19, 2017
Volt Resistance Heated Socks (All sizes) Deep penetrating heat garment and wraps
FDA Enforcement
Class II
·Terminated·2k Innovations Inc.·April 19, 2017
Volt Resistance Heated Therapy Shoulder Wrap Deep penetrating heat garment and wraps
FDA Enforcement
Class II
·Terminated·2k Innovations Inc.·April 19, 2017
Volt Resistance Heated Therapy Foot Wrap Deep penetrating heat garment and wraps
FDA Enforcement
Class II
·Terminated·2k Innovations Inc.·April 19, 2017
Volt Resistance Heated Elbow Garment Deep penetrating heat garment and wraps
FDA Enforcement
Class II
·Terminated·2k Innovations Inc.·April 19, 2017
Volt Resistance Heated Slipper (All sizes) Deep penetrating heat garment and wraps
FDA Enforcement
Class II
·Terminated·2k Innovations Inc.·April 19, 2017
Volt Resistance Unisex Rechargeable Heated Slipper (All sizes) Deep penetrating heat garment and wraps
FDA Enforcement
Class II
·Terminated·2k Innovations Inc.·April 19, 2017
Volt Resistance Heated Neck Garment Deep penetrating heat garment and wraps
FDA Enforcement
Class II
·Terminated·2k Innovations Inc.·April 19, 2017
Volt Resistance Heated Lower Back Garment Deep penetrating heat garment and wraps
FDA Enforcement
Class II
·Terminated·2k Innovations Inc.·April 19, 2017
- NTL-30 30ml Nutrio Enteral Feeding Syringe (sterile) - NTL-60 60ml Nutrio Enteral Feeding Syringe (sterile) - TL-INT-60 60ml Nutrio Enteral Feeding Syringe with Twistlok adapter (sterile) - INT-60 60mL Nutrio Intopo Enteral Feeding Syringe (sterile) - NGF-60 60ml Nutrio GraviFeed Syringe (sterile) The Enteral Syringe consists of a calibrated hollow cylindrical body and movable plunger. At the tip of the barrel is an oral lock connector. Product is considered sterile.
FDA Enforcement
Class II
·Terminated·Medela Inc. EF Division·March 18, 2015
BK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with software releases 1.2.0, 1.2.1 and 1.2.2. The system is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body, data processing and guidance of puncture and biopsy. The system performs simple geometric measurements and calculations in the following areas: Emergency Medicine, Anesthesia, MSK, Vascular, Cardiology, OB/GYN
FDA Enforcement
Class II
·Terminated·B-K Medical A/S·August 10, 2016