16 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HOSPIRA VITAL SIGNS WIRELESS MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR10906101·Piston spring screw 6 mm (5 pcs.)
Buccal Tubes
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746083617·DB TUBE INCONEL LOWER MOL 018 T-15 R=0 2MM
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0106100·Trial, 26 x 10mm, 8 Degree, Tapered, Straight
Footswitch (not USB port)
FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904001470·
RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RESOLUTION CHOLESTEROL MONITOR
FDA 510(k)
FDA Class 1
·Clinical Chemistry
TESS GLENOID REVERSE HEAD DIAMETER 36
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code KWS·October 27, 2016
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 2, 2013
5MM PEEK MULTIFUNCTION HANDLE
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY-SAN JOSE·Product code KOG·September 15, 2014
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 26, 2011
NEOPUFF INFANT RESUSCITATOR
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTL·November 10, 2011
BD SYRINGE 3ML HEPARIN
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NZW·September 9, 2019
ADULT INSPIRATORY HEATED BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·September 15, 2011
Merit Medical Surgical Convenience Kits, Custom and SPPT, Merit Medical, South Jordan, UT 84065. Part numbers: K05-01767A, K05-01769, K05-01769A, K09-03843M, K09-03951M, K09-05894F, K09-08610, K10-00033Q, K10-00382M, K10-00685K, K10-00984F, K10-01531F, K10-01826D, K10-01826F, K10-02902B, K10-03080D, K10-03378C, K10-03397B, K10-03590A, K10-03590B, K10-03659D, K10-03659F, K10-03659G, K10-03689, K10-03907B, K12-01342D, K12-01444B, K12-01468, K12-01484A, K12-01487, K12-01490A, K12-01593, K12-01638, K12-01661, K12-01667, K12-01667A, K12-01964, K12-01968, K12-02098, SPPT-100/C, SPPT-5F-10C, SPPT-5F-10L/A, SPPT-5F-7/C, SPPT-5F-7L/A.
FDA Recall
Terminated
·Merit Medical Systems, Inc·Product code LRO·August 15, 2007
Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019