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Medical device manufacturer

Sherwood Medical Co.

Sherwood Medical Co. holds 191 FDA 510(k) clearances across 83 product codes. Median elapsed review time is 43 days. openFDA lists no recall records naming the company.

Updated · ingest status · JSON

510(k) clearances
191
Product codes
83
Median review
43 days
Recall records
0

How does FDA spell Sherwood Medical Co.?

FDA publishes this company under a single spelling, so nothing needed merging here. Many manufacturers are not so tidy.

Which product codes does Sherwood Medical Co. file in?

83 product codes, ranked by how much they file in each.

Product codes this company holds clearances in, with their median elapsed review time in each.
CodeDeviceClearancesMedian reviewLatest
FMFSyringe, Piston2033 days
FMINeedle, Hypodermic, Single Lumen1383 days
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass1048 days
KNTTubes, Gastrointestinal (And Accessories)1040 days
JKATubes, Vials, Systems, Serum Separators, Blood Collection931 days
BSYCatheters, Suction, Tracheobronchial761 days
FOSCatheter, Umbilical Artery6167 days
BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)434 days
BTRTube, Tracheal (W/Wo Connector)425 days
CACApparatus, Autotransfusion458 days
CBTArterial Blood Sampling Kit4115 days
GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered416 days
JOLCatheter And Tip, Suction429 days
KNXCollector, Urine, (And Accessories) For Indwelling Catheter436 days
GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered317 days
GIMTubes, Vacuum Sample, With Anticoagulant381 days
GIOTube, Collection, Capillary Blood334 days
CAZAnesthesia Conduction Kit290 days
FCGBiopsy Needle246 days
FMHContainer, Specimen, Sterile217 days
FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature230 days
GAANeedle, Aspiration And Injection, Disposable29 days
GBSCatheter, Ventricular, General & Plastic Surgery224 days
GGPTest, Qualitative And Quantitative Factor Deficiency224 days
KDQBottle, Collection, Vacuum217 days

Showing the 25 they file in most, of 83.

Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.

Source: openFDA device/510k · retrieved

Has Sherwood Medical Co. had a recall?

openFDA lists no recall records naming this company. That is the absence of a record, not a guarantee — and it counts only recalls FDA has published under a spelling we resolved to this company.

Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.

Source: openFDA device/recall · retrieved

What has Sherwood Medical Co. cleared recently?

Most recent 510(k) clearances for this company, newest first.
510(k)DeviceCodeDecisionElapsed days
K981365MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONSMSD224
K960982MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. ACCESS CANNULAFMI287
K962880SENSI-TOUCH COMBO SPINAL/EPIDURAL REGIONAL ANESTHESIA DELIVERY SYSTEMCAZ138
K960574ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEMFHO175
K960677KANGAROO JEJUNAL FEEDING SYSTEMKNT87
K960632KANGAROO FEEDING TUBE PLACMENT STYLETKNT85
K955831ARGYLE ASPR-CARE CLOSED SUCTION SYSTEMBSY93
K954429KANGAROO ENTRISTAR SKIN-LEVEL GASTROSTOMY KITKNT168
K954525SENSI-TOUCH EPIDURAL ANESTHESIA FILTERBXN112
K950201ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETERJOL331

Source: openFDA device/510k · retrieved

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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.