20 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
CoRoent
FDA UDI
Nuvasive, Inc.·00887517630377·CoRoent Ant TLIF Ti, 13x10x32mm 15°
PROFILE
FDA UDI
Medos International Sàrl·10886705010448·PROFILE CANNULATED INTERFERENCE SCREW ROUND HEA...
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776173371·Stille-Horsley Fcps angled
ELMED INCORPORATED
FDA UDI
ELMED INCORPORATED·00198506072840·SCHROEDER TENACULUM SINGLE TOOTH FORCEP, BRAUN ...
Vilex Guidewire
FDA UDI
VILEX IN TENNESSEE, INC.·00841731120700·Steinmann Pin 3.5x230mm (9/64 x 9")
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780382898·Integra® Jarit® Stille-Horsley Rongeur, 9-3/4",...
ELMED
FDA UDI
ELMED INCORPORATED·00842180183339·SCHROEDER TENACULUM SINGLE TOOTH FORCEP, BRAUN...
POWDERFREE LATEX EXAMINATION GLOVES WITH BUBBLEGUM
FDA 510(k)
FDA Class 1
·General Hospital
ARM AUTOMATIC BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
SMARTSTITCH PERFECTPASSER
FDA Adverse Event
Other
·ARTHROCARE CORP.·Product code KOG·November 14, 2008
ASR UNI FEMORAL IMPL SIZE 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·September 1, 2011
DAILY ACTIVITY ASSIST DEVICES
FDA Adverse Event
LERADO GLOBAL·Product code ILS·July 16, 2013
VANGUARD COMPLETE KNEE FEMUR RIGHT 60MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·February 27, 2025
Mitek Profile 7 x 25 mm Cannulated Interference Screw Round Head Product Reference No.: 230325
FDA Recall
Terminated
·Mitek Worldwide·Product code HWC·February 28, 2003
Profile 7 x 25 mm Cannulated Interference Screw Round Head Catalog Number: 230325
FDA Recall
Terminated
·Mitek Worldwide·June 16, 2003
GE Healthcare Giraffe Omnibed Carestation CS1, combination infant incubator and infant warmer. Model Numbers: 1) 2082844-001-01040418; 2) 2082844-001-01046784; 3) 2082844-001-01052324; 4) 2082844-001-01052572; 5) 2082844-001-01055337; 6) 2082844-001-01065693; 7) 2082844-001-01069008; 8) 2082844-001-01073750; 9) 2082844-001-01086553; 10) 2082844-001-01089393; 11) 2082844-001-01090414; 12) 2082844-001-01092632; 13) 2082844-001-01111482; 14) 2082844-001-01115741; 15) 2082844-001-01122391; 16) 2082844-001-01128579; 17) 2082844-001-01128725; 18) 2082844-001-01131573; 19) 2082844-001-01140642; 20) 2082844-001-01165870; 21) 2082844-001-100397; 22) 2082844-001-100676; 23) 2082844-001-100740; 24) 2082844-001-100743; 25) 2082844-001-100744; 26) 2082844-001-101075; 27) 2082844-001-101149; 28) 2082844-001-101199; 29) 2082844-001-101202; 30) 2082844-001-101203; 31) 2082844-001-101356; 32) 2082844-001-101366; 33) 2082844-001-101656; 34) 2082844-001-102136; 35) 2082844-001-102589; 36) 2082844-001-102858; 37) 2082844-001-526493; 38) 2082844-001-533346; 39) 2082844-001-570904; 40) 2082844-001-615985; 41) 2082844-001-616544; 42) 2082844-001-674814; 43) 2082844-001-701655; 44) 2082844-001-704407; 45) 2082844-001-709042; 46) 2082844-001-857748; 47) 2082844-001-888278; 48) 2082844-001-941288; 49) 2082844-001-965539; 50) 2082844-001-978713; 51) 2082844-001-982099; 52) 2082844-001-982310; 53) 2082844-001-982985; 54) 2082844-001-982988; 55) 2082844-001-983509; 56) 2082844-001-983643; 57) 2082844-001-983679; 58) 2082844-001-984096; 59) 2082844-001-984948; 60) 2082844-001-987480; 61) 2082844-001-987855; 62) 2082844-001-993967; 63) 2082844-001-994441; 64) 2082844-001-995782; 65) 2082844-001-998377; Radiant infant warmer
FDA Enforcement
Class I
·Completed·DATEX--OHMEDA, INC.·November 6, 2024
Compress, Mini Compress; Item Nos. 178350 178351 178352 178353 178354 178355 178356 178357 178358 178359 178360 178361 178362 178363 178364 178365 178366 178367 178368 178369 178370 178371 178372 178373 178464 178472 178480 178488 178496 178504 178575 178576 178577 178578 178579 178580 178730 178731 178732 178733 178734 178735 178354S 178754 178755 178756 178757 178758 178759 Product Usage: 1) Correction of revision of unsuccessful osteotomy, arthrodesis or previous joint replacement 2) Tumor resections 3) Revision of previously failed total joint arthroplasty 4) Trauma The ComPreSs Distal Femoral Replacement System is intended for uncemented use.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019
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
Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·January 22, 2014