14 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HUNTLEIGH FETAL DOPPLER, FD-1 & DOPCORD, D140
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
NA
FDA UDI
Smith & Nephew, Inc.·00885554007077·SOD SWITCHING STICK 5.5MM X 10
VERTEX® Reconstruction System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00721902180866·SCREW 6900618 VAS CANCELLOUS 4.0X18MM TI
FLR Mesh L33mm
FDA UDI
SPECIALTY APPLIANCES, LLC·D8199006180·
Anodyne Surgical
FDA UDI
Psi/Eye-Ko, Inc.·00840516117799·Chamber Maintainer 18g, with serrated tip
Anodyne Surgical
FDA UDI
Psi/Eye-Ko, Inc.·00840516110097·Chamber Maintainer 18g, with serrated tip
TCP
FDA UDI
WRIGHT MEDICAL TECHNOLOGY, INC.·00840420117922·
SCANDINAVIAN IVF SCIENCES AB, THAW-KIT 1
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CYNOSURE SMARTCOOL FAMILY COLD AIR DEVICE: SMARTCOOL, SMARTCOOL 6 AND CRYO C
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GMK-REVISION FEMUR REVISION PS SIZE 3 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·August 5, 2020
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·June 27, 2014
MAXCEM ELITE
FDA Adverse Event
Injury
·KERR CORPORATION·Product code EMA·January 7, 2013
GPS PROCEDURAL STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code INK·November 8, 2010
LAPAROSCOPY GYN PACK - (1) TABLE COVER REINFORCED 44" X 78" (1) LAPAROSCOPY SHEET "T" SMS (3) TOWELS ABSORBENT 15" X 20" (1) SURGICAL BLADE#11 STAINLESS STEEL (1) MAYO STAND COVER REINFORCED (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK (2) LEGGINS WITH 7" CUFF 30" x 42" (1) UNDERBUTTOCK DRAPE WITH POUCH 44" X 35" (4) DRAPE UTILITY WITH TAPE (2) GOWN IMPERVIOUS REINFORCED LARGE SMS (1) CONNECTING TUBING 3/16" X 12" EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014