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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19 GA PLASTIC REINFORCED EPIDURAL CATHETER
FDA 510(k)
FDA Class 2
·Anesthesiology
Custom Procedure Kit
FDA UDI
MEDIVATORS INC.·40677964015081·The ENDO CARRY-ON Procedure Kit contains all of...
TruForm
FDA UDI
Rmo, Inc.·00885797099709·MX MLR BDS R/L SE ASIA ASST100
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001587·artVeneer life lower anteriors, UBS, BL2
HEYER-SCHULTE DOUBLE LUMEN BREAST IMPLANT
FDA Adverse Event
MENTOR CORP.·Product code FTR·April 14, 1994
UniTip Catheter
FDA UDI
Unisensor AG·07640172972427·
PTA BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
SHUTTLE STOP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MINMED QUICK SET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·May 26, 2025
ALIGN TO URETHRAL SUPPORT SYSTEM - HOOK
FDA Adverse Event
Injury
·BARD SHANNON LTD·Product code FTL·March 11, 2013
FREESTYLE FLASH
FDA Adverse Event
Injury
·Product code NBW·February 25, 2011
CAPTURE-R READY-SCREEN TEST WELLS
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·February 25, 2008
HLM TUBING SET
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTM·July 6, 2016
Universal Pack, Catalog number 900-1587. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code LRO·October 8, 2014
Universal Pack, Catalog number 900-1587. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Enforcement
Class I
·Terminated·Customed, Inc·December 10, 2014
UNIVERSAL PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
FDA Enforcement
Class II
·Terminated·Customed, Inc·September 9, 2015
UNIVERSAL PACK - (1) TRAY ORGANIZER FULL DEEP (1) ANESTHESIA SPINAL NEEDLE 22G X 3 ~ UF (1) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK UF (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK UF (1) NEEDLE HYPODERMIC 20G X 1 ~ UF (2) GOWN IMPERVIOUS REINFORCED X-LARGE SMS AAMI Ill (1) SHEET SPLIT WITH ADHESIVE 108" X 77" STD SMS LIF (1) SHEET% 57" X 63" REINFORCED SMS LIF (2) TOWELS ABSORBENT 15" X 20" LIF (4) DRAPE UTILITY LIF (1 0) GAUZE SPONGES 4" X 4" 12PL Y LIF (4) CLOTH HUCK TOWELS BLUE LIF (1) TABLE COVER REINFORCED 50" X 90" UF (1) SCALPEL WITH HANDLE #11 (1) DENTURE CUP WITH LID (1) TRAY 2 COMPARTMENT (2) ABSORBENT TIP APPLICATOR (1) IMPERVIOUS STOCKINETIE 14" X 48" LIF (1) TAPE TRANSPORE 1" X 36" (1) DIISP NEEDLE 30 X ~ (1) PROBE DRAPE 6" X 96 WITH GEL (1) ARTERIAL NEEDLE 18 X 2 % (1) CATHETER INTRODUCER 7FR (1) NEEDLE & BLADE COUNTER 10c MAG/CLEAR L/F 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
bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024