30 results
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18ms
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Sources: EU EUDAMED, US FDA
TANIT HOME SUNTANNING UNIT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306835964·Stainless Steel Stand for Reusable 2L Canister
ACUMED
FDA UDI
Acumed LLC·10806378045561·.062" (1.6mm) x 9.25" Guide Wire
Smart Correction
FDA UDI
Wishbone Medical, Inc.·B5621070208009500·Dual Joint Express Strut, XXShort, Non-Sterile
STIWELL MED4
FDA 510(k)
FDA Class 2
·Physical Medicine
EMBRYO TRANSFER CATHETER SET, MODEL 320200 AND 320201
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·October 2, 2008
COLLEAGUE II - TRIPLE CHANNEL IV PUMP
FDA Adverse Event
BAXTER·Product code FRN·December 6, 2002
WishBone Medical Smart Correction Dual Joint Express Struts, external skeleton fixation device Type Part Number XXS 10-702-080095-0 XS 10-702-095115-0 Short 10-702-115150-0 Medium 10-702-140200 Long 10-702-190300-0
FDA Enforcement
Class II
·Ongoing·Wishbone Medical, Inc.·February 15, 2023
NA
FDA Adverse Event
Malfunction
·STRYKER SUSTAINABILITY SOLUTIONS LAKELAND·Product code NUJ·May 8, 2014
ZIMMER SKIN GRAFT MESHER
FDA Adverse Event
Injury
·ZIMMER SURGICAL·Product code GFD·October 18, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 7, 2007
SURESCAN
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·August 2, 2018
WishBone Medical Smart Correction Dual Joint Express Struts, external skeleton fixation device Type Part Number XXS 10-702-080095-0 XS 10-702-095115-0 Short 10-702-115150-0 Medium 10-702-140200 Long 10-702-190300-0
FDA Recall
Open, Classified
·Wishbone Medical, Inc.·Product code KTT·January 4, 2023
VOLISTA StandOP Surgical Light; Model numbers VLT600 SF AIM STP, VLT600 DF AIM STP, Ref. codes ARD568811901, ARD568811911 ARD568811951, ARD568811961 The device is designed to illuminate the body of a patient during surgical operations, diagnostics and treatment. These surgical lights may be installed in surgical suites, examining rooms, doctors' surgeries and outpatient consultations.
FDA Recall
Terminated
·GETINGE US SALES LLC·Product code FSY·February 7, 2018
Monomid Non-Absorbable Suture are blue, monofilament synthetic absorbable suture, with different sizes and different needle sizes. The products are labeled in parts. These sutures are intended for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic, and neurological surgery.
FDA Recall
Terminated
·C P Medical Inc.·Product code GAR·June 29, 2011
Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per box. Product Usage: Plain Gut Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neural tissues.
FDA Recall
Open, Classified
·CP Medical Inc·Product code GAL·February 4, 2019
Maquet XS Flat Screen Monitor Holder, XS32 SPE, Configuration Part Number ARD22201040A Product Usage: This product is designed to support one or two medical grade flat screen(s) alone or in association with surgical lights.
FDA Recall
Terminated
·GETINGE US SALES LLC·Product code FSY·January 8, 2019
Maquet XS Flat Screen Monitor Holder, PWD70+DF HD R XS32 K3 SPE, Configuration Part Number ARD268400150A Product Usage: This product is designed to support one or two medical grade flat screen(s) alone or in association with surgical lights.
FDA Recall
Terminated
·GETINGE US SALES LLC·Product code FSY·January 8, 2019
Maquet XS Flat Screen Monitor Holder, SAT XS32 12 SPE, Configuration Part Number ARD2SAT00130A Product Usage: This product is designed to support one or two medical grade flat screen(s) alone or in association with surgical lights.
FDA Recall
Terminated
·GETINGE US SALES LLC·Product code FSY·January 8, 2019