22 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain Technology
FDA 510(k)
FDA Class 2
·General Hospital
HHM
FDA UDI
Oticon A/S·05707131284662·H150V2, MINIRITE 312 WL CBE HHM
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306803857·Rz2: Temporal Line of Fusion Zygomatic and Midf...
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100035·BARRAQUER HEAVY WIRE SPECULUM LARGE
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100042·BARRAQUER WIRE SPECULUM LARGE
TIBIAL INSERT IMPACTOR TIP
FDA Adverse Event
Malfunction
·CONFORMIS, INC.·Product code OOG·April 28, 2017
Alleset
FDA UDI
GRI Medical & Electronic Technology Co., Ltd.·16931918138145·Head Cradle_Pediatric_7 x 6.25 x 3.5in(18 x 16 ...
Tibial Offset Cutting Block Right 5
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215056971·
LOGIFLEX LAPAROSCOPIC BAND POSITIONING DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TRILLIUM BIOPUMP PLUS, MODEL BPX80T
FDA 510(k)
FDA Class 2
·Cardiovascular
VERSACROSS CONNECT LAAC ACCESS SOLUTION
FDA Adverse Event
Injury
·BAYLIS MEDICAL COMPANY INC.·Product code DRE·April 6, 2023
S-LIFT Extension Shims Extension shims are manufactured from grade 5 titanium and are curved, rectangular slabs which have four protrusions used for ratcheting. They come in straight and pointed varieties, either with or without a tab containing an additional bend. Extension shims are designed to slide down retractor blades, and are optional retractor components utilized during lumbar interbody fusion procedures. They are intended to manipulate tissue and prevent tissue from interfering inside the surgical field.
FDA Enforcement
Class II
·Terminated·SpineFrontier, Inc.·November 20, 2013
V SERIES MONITOR
FDA Adverse Event
Other
·MINDRAY DS USA, INC.·Product code MHX·May 31, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 5, 2011
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·August 29, 2008
MICROVASCULAR PLUG
FDA Adverse Event
Injury
·REVERSE MEDICAL·Product code KRD·September 8, 2021
MICROVASCULAR PLUG
FDA Adverse Event
Injury
·REVERSE MEDICAL·Product code KRD·September 8, 2021
VERSACROSS ACCESS SOLUTION
FDA Adverse Event
Injury
·BAYLIS MEDICAL COMPANY INC.·Product code DXF·April 19, 2023
VERSACROSS ACCESS SOLUTION
FDA Adverse Event
Injury
·BAYLIS MEDICAL COMPANY INC.·Product code DYB·April 20, 2023
VERSACROSS CONNECT LAAC ACCESS SOLUTION
FDA Adverse Event
Injury
·BAYLIS MEDICAL COMPANY INC.·Product code DXF·April 25, 2023