20 results · 21ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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