17 results
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17ms
·
Sources: EU EUDAMED, US FDA
DU PONT MAMMOGRAPHY CASSETTE
FDA 510(k)
FDA Class 2
·Radiology
VERTEX® Reconstruction System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00721902180873·SCREW 6900620 VAS CANCELLOUS 4.0X20MM TI
FLR Mesh L35mm
FDA UDI
SPECIALTY APPLIANCES, LLC·D8199006200·
Peremes vápabenyomó fej-L
Device
EU MDR
·
Eu Md Class 1
·Sanatmetal Orthopaedic and Traumatologic Equipment Manufacturer Ltd.·On the market
YEOMAN BIOSPY PUNCH RONGEUR
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896020283·YEOMAN BIOSPY PUNCH RONGEUR SMALL SQUARE BASKET
TCP
FDA UDI
WRIGHT MEDICAL TECHNOLOGY, INC.·00840420117700·
QUIKCLOT INTEVENTIONAL, MODEL P/N 182
FDA 510(k)
FDA Unclassified
·Unknown
PBN FALLOPIAN TUBE CATHETER SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 27, 2014
FUSIONBOLT Ø6.5 L110 TAN
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code KTT·January 7, 2013
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·November 16, 2010
Arthroscopy Pack, Catalog number 900-620. 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 FWZ·October 8, 2014
Arthroscopy Pack, Catalog number 900-620. 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
ARTHROSCOPY PK 5/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
ARTHROSCOPY PACK - (1) MAYO STAND COVER REINFORCED LIF (1 0) GAUZE SPONGES 4" X 4" 16PL Y (1) TUBE SUCTION CONNECTING X" X 12' LIF (1) IMP. STOCKINETTE (1) SURGICAL BLADE #11 STAINLESS STEEL (1) ANESTHESIA SPINAL NEEDLE 18G X 3 ~ (1) SYRINGE Sec WITH NEEDLE 21G X 1 ~ LUER LOCK LIF (2) ELASTIC BANDAGE 6" X 5yrd LIF (1) TUR Y SET 81 "2.1m REGULAR CLAM (2) NEEDLE HYPODERMIC 18G X 1 ~ (1) TABLE COVER 50" X 90" REINFORCED LIF (5) TOWEL ABSORBENT 15" X 20" LIF (2) DRAPE UTILITY WITH TAPE LIF (1) DURAPREP SURGICAL SOLUTION 26m I LIF (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (1) Pr. NEUTRALON SURGEON GLOVES #7.5 (1) Pr. NEUTRALON SURGEON GLOVES #8 (1) Pr. NEUTRALON SURGEON GLOVES #8.5 (2) GOWN IMPERVIOUS REINFORCED X-LARGE SMS (10) GAUZE SPONGES 4" X 4" 16PLY XRD (2) STRIPS TAPE (1) SHEET ARTHROSCOPY T STD SMS WITH POUCH LIF (1) DRAPE VIDEO CAMERA LIF 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
Examination Table / Bed, Size: 1900 × 620 × 700 mm. Back section: 695 × 620 mm, Back rest adjustable by double ratchet, Framework made of Stainless Steel.
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Narang Medical Limited·1 device
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017