22 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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REBAR MICRO CATHETER: REBAR-18 [2.3F], 110 CM, 130 CM, 153 CM, SINGLE MARKER BAND AND 153 CM, DUAL MARKER BAND
FDA 510(k)
FDA Class 2
·Cardiovascular
Sledgehammer
FDA UDI
Keystone Industries·H66810019661·HC 5 llb Pwd & 1 Qt Liq Kit, Lt Fibered Plus
SCANLAN® Easy-Tag™ Tracking System
FDA UDI
SCANLAN INTERNATIONAL INC·00846159029215·Easy-Tag, Mini, Yellow, 250/BX
Procelain Conditioner
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746007835·PORCELAIN CONDITIONER 6 CC
Porcelain Conditioner
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746061455·PORCELAIN CONDITIONER 6 CC
LIFEPAK® 15 monitor/defibrillator
FDA UDI
PHYSIO-CONTROL, INC.·00883873871607·15AABAABBBABAABAAAAAAAAFLP15 MONITOR/DEFIB
CD HORIZON ECLIPSE
FDA 510(k)
FDA Class 2
·Orthopedic
4631 DUO DELIVERY SYSTEM
FDA 510(k)
FDA Class 1
·Dental
SMARTSTITCH PERFECTPASSER SUTURE CARTRID
FDA Adverse Event
Malfunction
·ARTHROCARE CORP.·Product code GAT·December 12, 2018
TRUFILL DCS ORBIT MINI COMPLEX FILL
FDA Adverse Event
Injury
·CORDIS NEUROVASCULAR, INC.·Product code HCG·August 13, 2008
DEXTRUS 4137
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVN·March 13, 2013
ACCESS® 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·February 27, 2011
TRIDENT CERAMIC INSERT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code MRA·February 21, 2008
Catalog Number: 9001966 LIVER & PANCREAS SURGERY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code LRO·January 7, 2016
Higado & Pancrea Pack, Catalog number 900-1966. 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
Higado & Pancrea Pack, Catalog number 900-1966. 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
Catalog Number: 9001966 LIVER & PANCREAS SURGERY 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·April 20, 2016
HIGADO Y PANCREA 2/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
HIGADO & PANCREA PACK - (1) BAG SUTURE FLORAL (2) YANKAUER SUCTION TUBE WITHOUT VENT (4) DRAPE UTILITY WITH TAPE (6) TOWELS CLOTH HUCK BLUE (1) SHEET DRAPE 41 " X 58" SMS (1) MAYO TRAY LARGE (1) TABLE COVER REINFORCED 50" X 90" (1) DRAPE INCISE ANTIMICROBIAL 23" X 17" (1) DRAPE BARIATRIC (1) BLADE SURGICAL #10 STAINLESS STEEL (1) CUP SPECIMEN WITH CAP 4oz (1) BLADE SURGICAL #15 STAINLESS STEEL (30) LAP SPONGE PREWASH 18" X 18" XRD (1) STRIP STERI CLOSURE W X 4" (1) POLISHER CAUTERY TIP (1) NEEDLE ECLIPSE 22 X 1 Y2 (4) TOWEL ABSORBENT 15" X 20" (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK (2) LITE GLOVE (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER (1) COUNTER NDLE/BLADE 60C FOAM/STR/MAG/STR (1) FORCE TRIVERSE (1) SYRINGE BULB 60CC (1) BLADE EXTENDED ELECT. 16.51cm (2) TUBE SUCTION CONNECT Y." X 12' (2) CHLORAPREP 26ML APPLICATOR TEAL (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE Product Usage: 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
ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare, Llc·February 5, 2014