20 results
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36ms
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Sources: EU EUDAMED, US FDA
TYPE INTERFACE 9271/1 INCUBATOR/WARMER
FDA 510(k)
FDA Class 2
·General Hospital
ENDO-SCRUB®
FDA UDI
MEDTRONIC XOMED, INC.·20681490050849·SHEATH 1912000 5PK 4MM/0DEG STORZ XOMED
PAQ.120X100X150*31*CTG.FHR240
FDA UDI
AB MEDICA GROUP, S.A.·08428763008798·
WATER TRAP, SELF SEALING HIGH VOLUME
FDA UDI
Intersurgical Incorporated·05030267084388·WATER TRAP, SELF SEALING HIGH VOLUME
ENDO-SCRUB®
FDA UDI
MEDTRONIC XOMED, INC.·20643169437207·SHEATH 1912000 5PK 4MM/0DEG STORZ XOMED
RUSCH
FDA UDI
TELEFLEX INCORPORATED·14026704744296·HEAD HARNESS - CHILD
RUSCH
FDA UDI
TELEFLEX INCORPORATED·04026704544646·HEAD HARNESS - CHILD
RUSCH
FDA UDI
TELEFLEX INCORPORATED·14026704641526·HEAD HARNESS - CHILD
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·04546540364661·UPPER-FACE FIXATION MODULE
Reprocessed Endoscrub Sheath, 4mm, 0 deg
FDA UDI
SURETEK MEDICAL·B3901912000·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450239582·
Ocata Anterior Cervical System
FDA UDI
Kalitec Direct LLC·B07308K0120000·Screw Driver, Cannulated Assembly
1.5MM BONE FIXATION KIT
FDA 510(k)
FDA Class 2
·Orthopedic
VITEK 2 STREPTOCOCCUS PENICILLIN
FDA 510(k)
FDA Class 2
·Microbiology
INTEGRATED APD SET W/CASSETTE3-PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·December 1, 2010
DRILL 3055601 SKEETER OTO-TOOL
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC·Product code ERL·January 11, 2013
UNKNOWN DEPUY PATELLAR COMPONENT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·July 3, 2014
- ACCU-PASS Suture Shuttle, 70 Degree, Upbend, (Orange) Ref. 72200419 Lot 122504 - Carpal Tunnel Release Blade Assembly, (White) Ref. 81010 Lot 123263, 122406, 122482, 123043, 122518, 122511 - ENDO-SCRUB 2, (1) Sheath, 0 Degree, For K. Storz, Medtronic Sharpsite AC, (Green) 4.0mm Ref. 19-12000 Lot 122289 - Spectrum II Disposable Suture Hook 45 degree, Right (RED) Ref. C6380 Lot 122592 Orthopedic manual surgical instrument.
FDA Enforcement
Class II
·Terminated·Surgical Instrument Service And Savings, Inc.·July 10, 2013
- ACCU-PASS Suture Shuttle, 70 Degree, Upbend, (Orange) Ref. 72200419 Lot 122504 - Carpal Tunnel Release Blade Assembly, (White) Ref. 81010 Lot 123263, 122406, 122482, 123043, 122518, 122511 - ENDO-SCRUB 2, (1) Sheath, 0 Degree, For K. Storz, Medtronic Sharpsite AC, (Green) 4.0mm Ref. 19-12000 Lot 122289 - Spectrum II Disposable Suture Hook 45 degree, Right (RED) Ref. C6380 Lot 122592 Orthopedic manual surgical instrument.
FDA Recall
Terminated
·Surgical Instrument Service And Savings, Inc.·Product code LXH·May 3, 2013
Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.
FDA Enforcement
Class II
·Terminated·Merit Medical Systems, Inc.·November 30, 2016