18 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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XO CROSS CORONARY Support Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
NA
FDA UDI
Medos International Sàrl·10886705003488·DISTAL RIB CLEAR CANNULA WITH OBTURATOR 5.5mm x...
DePuy Mitek
FDA UDI
Provision·B504TC2141070·
Reprocessed Distal Rib Clear Cannula with Obturator, 5.5mm x 75mm
FDA UDI
SURETEK MEDICAL·B3902141071·
Adler Instrument Company
FDA UDI
Adler, Inc.·00810123202324·Ballenger Sponge Forceps,strai
ALEUTIAN® Interbody Systems
FDA UDI
VB Spine LLC·10888857522312·Trial Size 13x16x14 mm, 12°
DRILL GUIDE
FDA UDI
Biomet Orthopedics, LLC·00887868024085·
Tandry Locking Plate System
FDA UDI
MICROWARE PRECISION CO., LTD.·04719873094530·Cortex Screw 1.5mm, 7mm, Hexalobular
THREADED DRILL SLEEVE
FDA UDI
Biomet Orthopedics, LLC·00887868024108·
THREADED DRILL GUIDE
FDA UDI
Biomet Orthopedics, LLC·00887868024092·
Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ENDIUS CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
RAVINE Lateral Access System
FDA UDI
VB Spine LLC·10888857214989·ACDF PIN Size 60 mm
NATURAL-KNEE II SYSTEM POROUS COATED REVISION TIBIAL BASEPLATE
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code HSH·October 24, 2008
MAYFIELD MODIFIED SKULL CLAMP
FDA Adverse Event
Other
·INTEGRA, CINCINNATI·Product code HBL·July 20, 2011
RSP SHOULDER
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code KWS·July 3, 2013
STERRAD CYCLESURE 24 Biological Indicator (BI) product, P/N 14324. Validation kits with Sterrad Cyclesure 24 BI products: Codes/Serial Numbers, Product Description: 14324 Sterrad Cyclesure 24 Biological Indicator. 14324-02 Sterrad Cyclesure 24 Biological Indicator. 10134 Sterrad 100NX Express Cycle Kit. 10135 Sterrad 100NX Express Cycle Upgrade Kit. 10137 Sterrad 100NX Duo Cycle Upgrade kit. 14325 Cyclesure Challenge Pack Kit. 20103 Sterrad 100NX Test Pack Kit. 20228 Sterrad 100NX Intl Validation Kit. 20229 Sterrad 100NX Validation Kit, USA. 20232 Sterrad 50/100S Validation Kit. 20236 Sterrad 50/100S Validation Kit. 20248 Sterrad 100NX Express Validation Kit. 20253 Sterrad NX Validation Kit. 20254 Sterrad NX Validation Kit Domestic, US. The Sterrad Cyclesure 24 Biological Indicator (BI), P/N 14324 is intended to be used as a standard method for frequent monitoring of the Sterrad Sterilization System cycles.
FDA Enforcement
Class II
·Terminated·Advanced Sterilization Products·December 19, 2012
18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer 10041227 & 10789400 S1000 10441701 S2000 10041461 S2000 (Refurb) - 10440017 S3000 10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017