52 results
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18ms
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Sources: EU EUDAMED, US FDA
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Mindray V12 Size: 320 mm X 320 mm X 450 mm N.W.: 3 kg G.W.: 6 kg Qty:1 Manufactured in China Mindray V21 Size: 515 mm X 335 mm X 685 mm N.W.: 8 kg G.W.: 11 kg Qty:1 Manufactured in China One product, V Series monitor, available in two sizes: The V12 has a 12 inch screen, the V21 has a 21 inch screen. The V Series Monitor is a Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices. It also monitors of the following human physiological parameters: 1) ECG waveform derived from 3, 5, 6 and 12 lead measurements, 2) Heart Rate, 3) Pulse Oximetry (Sp O2), 4) ST Segment Analysis, 5) Arrhythmia Detection, 6) Non Invasive Blood Pressure (NIBP), 7) Invasive Blood Pressure (IBP), 8) Cardiac Output (CO), 9) Respiratory Gasses, 10) Respiration Rate, 11) Temperature, It is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner.
FDA Recall
Terminated
·Mindray DS USA, Inc. d.b.a. Mindray North America·Product code MHX·September 24, 2012
Giraffe OmniBed Carestation CS1, Model Numbers: a. 2082844-001-XXX, b. 2074920-001-XXXXXX, c. M1050205, d. M1135822, e. M1145475, f. M1145476, g. M1235957, h. M1149051, i. M1146098; Labeled as the following: GIRAFFE OMNIBED CARESTATION CS1, GIRAFFE OMNIBED CARESTATION, GIRAFFE OMNIBED, GIRAFFE OMNIBED CS1, OMNI G 115/230V SERVO2 CARESTATION, ASSY-LAU, OMNIBED CHINA EBASE S HUMID, Manufacturing assembly - Make, OBSOLETE-Omnibed Czech Servo O2 Nist/Scale/Re-usable Probe/SW w/port hole/CE Plug, ASSY-LAU, Omnibed Czech S-PH w/Nist O2 w/Reus Probe CE Power Cord, Finished good - Make, ASSY-LAU, Omnibed Czech S-PH w/Reusable Probe CE Power Cord, Finished good - Make, Omnibed Czech Servo O2 Nist/Scale/Re-usable Probe/SW w/port hole/Ce Plug, ASSY-LAU, Omnibed Indonesian S-GR W/Reuseable Probe CE Plug, Finished good - Make, ASSY-LAU, Omnibed ENG S-Gr w/REUProbe CE Power Cord, Finished good - Make, ASSY-LAU, Omnibed Portuguese S-PH w/NIST O2w/Reusable Probe CE Power Cord, Finished good - Make. Incubator, Neonatal, Warmer, Infant radiant
FDA Recall
Open, Classified
·DATEX--OHMEDA, INC.·Product code FMZ·May 19, 2023
Mindray V21, Size: 515 mm X 335 mm X 685 mm, N.W.: 8 kg, G.W.: 11 kg, Qty:1 The V-Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for use include the monitoring of ECG waveform derived from 3,5,6 and 12-lead measurements, Heart Rate, Pulse Oximetry (Sp)s), ST Segment Analysis, Arrhythmia Detection, Non Invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Cardia Output (CO), Respiratory Gases, Respiration Rate and Temperature.
FDA Recall
Terminated
·Mindray DS USA, Inc. dba Mindray North America·Product code MHX·July 31, 2014
PREMIUM ARTHROSCOPY PACK - CUSTOMED- (1) ARTHROSCOPY SHEET T WITH POUCH LIF (1) IMPERVIOUS STOCKINETTE (3) STRIPS TAPE 24" X 4" (1) DRAPE U WITH TAPE SPLIT (2) TOWELS ABSORBENT 15" X 20" LIF (1) GOWN IMPERVIOUS REINFORCED X-LARGE SMS (1) GOW SURG. REINFORCED LARGE TOWEL/WRAP (1) TABLE COVER REINFORCED 50" X 90" LIF (1) MAYO STAND COVER REINFORCED LIF (1) CONTAINER SPECIMEN 4oz WITH LID & LABEL (1) TUBE SUCTION CONNECT. }4" X 12' LIF (1) SURGICAL BLADE #11 CARBON STEEL (1 ELASTIC BANDAGE 6" X 5 YRD. L/F 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 FWZ·May 20, 2014
PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
FDA Recall
Terminated
·Ethicon, Inc. Us·Product code GAW·May 7, 2018
PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
FDA Recall
Terminated
·Ethicon, Inc. Us·Product code GAW·May 7, 2018
CORE Trumpet Handpiece only, Catalog Number CD8450 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures
FDA Recall
Terminated
·ConMed Corporation·Product code GBW·June 27, 2016
Surgipro Monofilament Polypropylene Sutures Product Description CP-535 SURGIPRO* 1 BLU 100CM GS24 X36 CP-824 SURGIPRO* 1 BLU 150CM GS26 X24 CP-825 SURGIPRO* 2 BLU 150CM GS26 X24 VP-543 SURGIPRO* 2-0 BLU 120CM V20 DA
FDA Recall
Open, Classified
·Product code GAW·December 2, 2022
PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
FDA Recall
Terminated
·Ethicon, Inc. Us·Product code GAW·May 7, 2018
PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
FDA Recall
Terminated
·Ethicon, Inc. Us·Product code GAW·May 7, 2018
PRONOVA SUTURE BLUE 122CM M1.5, D10189
FDA Recall
Terminated
·Ethicon, Inc. Us·Product code GAW·May 7, 2018
PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
FDA Recall
Terminated
·Ethicon, Inc. Us·Product code GAW·May 7, 2018
9200C and 9200D Laryngeal Strobe Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video data of laryngeal or pharyngeal structures, and audio data, for medical and pedagogical applications.
FDA Recall
Terminated
·Pentax of America Inc·Product code GCW·April 13, 2017
CORE Trumpet Handpiece with 5mm x 32cm Length Probe , Catalog Number CD8400 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures
FDA Recall
Terminated
·ConMed Corporation·Product code GBW·June 27, 2016
Peritoneal Lavage Kits, Model number AK-09000
FDA Recall
Terminated
·Arrow International Inc·Product code GBW·August 2, 2004
Peritoneal Lavage Kits, Model number AK-09001
FDA Recall
Terminated
·Arrow International Inc·Product code GBW·August 2, 2004
Boston Scientific vanSonnenberg Sump with ''J'' Tip, 30 cm, 14Fr (4.7 mm), for percutaneous abscess and fluid drainage, single use only, sterile; UPN M001202010, REF/Catalog No. 20-201.
FDA Recall
Terminated
·Boston Scientific Corp·Product code GBW·August 10, 2006
7245C, 7245C/E, 7245D Computer Digital Video System Product Usage: The 7245C, 7245C/E and 7245D are used to electronically record, display, transfer, and store digital video data of behavior related to swallowing in the pharyngeal area for medical and pedagogical applications.
FDA Recall
Terminated
·Pentax of America Inc·Product code GCW·April 13, 2017
PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
FDA Recall
Terminated
·Ethicon, Inc. Us·Product code GAW·May 7, 2018
PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
FDA Recall
Terminated
·Ethicon, Inc. Us·Product code GAW·May 7, 2018