24 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVE
FDA 510(k)
FDA Class 2
·General Hospital
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00312251·
DIASOL
FDA UDI
DIASOL, INC.·B467100322575100·Diasol Liquid Acid Concentrate for Bicarbonate ...
DIASOL
FDA UDI
DIASOL, INC.·B467100322575200·Diasol Liquid Acid Concentrate for Bicarbonate ...
SCANLAN® Needle Holders
FDA UDI
SCANLAN INTERNATIONAL INC·00846159003000·Jacobson Micro Needle Holder Flat Handle
FacetFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361020011·Facet Screw Assy, SOTW, 5.5 x 25mm
NA
FDA UDI
STRYKER CORPORATION·04546540046550·Precision Thin (9.0 x 0.38 x 31.0mm)
CARD GUARD PERSONAL ELECTROCARDIOGRAM TRANSMITTER, MODEL CG-6206/6306
FDA 510(k)
FDA Class 2
·Cardiovascular
ACCUSIGN AMP 300, BIOSIGN AMP 300, STATUS DS AMP 300, SYVA RAPID TEST D.A.U.
FDA 510(k)
FDA Class 2
·Clinical Toxicology
HNM MEDICAL
FDA UDI
HNM STAINLESS, LLC.·00842962156353·FUKUDA KUJAT RETRACTOR, 8 3/4", SMALL, 1 3/8" B...
SYNCHROMED
FDA Adverse Event
Injury
·NEURO·Product code LKK·November 24, 2003
SCHRONOS BETA-TCP STRIP 100M X 25MM X 3MM-STE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code MQV·September 17, 2012
BIO-CORKSCREW SUTURE ANCHOR
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code MAI·February 21, 2007
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013
YSIO S
FDA Adverse Event
Injury
·SIEMENS AG·Product code MQB·February 28, 2011
ACCU-CHEK ULTRAFLEX INFUSION SET
FDA Adverse Event
Malfunction
·DISETRONIC MEDICAL SYSTEMS, INC.·Product code FPA·February 22, 2008
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-25.
FDA Recall
Open, Classified
·Fresenius Kabi USA, LLC·Product code FRN·June 24, 2025
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-25.
FDA Enforcement
Class II
·Ongoing·Fresenius Kabi USA, LLC·August 6, 2025
Torque Limiting Adapter: Torque Limiting Attachment, Non Sterile, Distributed by Zimmer. PRECIMED, Torque Limiting Adaptor, Non Sterile.. Customer Number/Model: 00-2360-080-00 T10232, T116245 T116245, TLA025-25 TLA025-25, 00-2360-080-05 T10233, MAC21003 T116430, TLA025-30 TLA025-30, MAC21001 T112972, MAC21001 T13621, TLA025-20 TLA025-20.
FDA Enforcement
Class II
·Terminated·Greatbatch Medical·June 8, 2016
Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.
FDA Recall
Open, Classified
·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code EOQ·September 25, 2023