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Sims Portex, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
16
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K012277PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILEFebruary 11, 2002
K012068WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733SAugust 3, 2001
K011925HYPODERMIC NEEDLE-PRO NEEDLE WITH NEEDLE PROTECTION DEVICE; HYPODERMIC NEEDLE-PRO SYRINGE & NEEDLE WJuly 12, 2001
K002201ELECTROSTATIC HYDROPHOBIC BREATHING FILTERFebruary 5, 2001
K002506BREATHING FILTER FOR DISPOSABLE ANESTHESIA BREATHING CIRCUITDecember 14, 2000
K001555SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26August 2, 2000
K001318CPAP SYSTEM, MODEL 102001July 20, 2000
K993619CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCKApril 28, 2000
K000628WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET-17G, MODEL MEONS1733March 13, 2000
K994275SIMS PORTEX ANESTHESIA CATHETERFebruary 22, 2000
K9918611ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR, BJanuary 18, 2000
K992471SIMS PORTEX EPIDURAL CATHETER, 20G MODEL# 4910-16/17; 21G MODEL# 4910-18October 22, 1999
K992057IST RESPONSE MANUAL RESUSCITATOR, MODELS, 008000, 008003,008006September 13, 1999
K983858SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLESJanuary 29, 1999
K981035PRO-VENT, PULSATOR ARTERIAL BLOOD SAMPLING SYRINGESApril 21, 1998
K980466PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE AND DISPOSABLE INNFebruary 24, 1998