Medical device manufacturer
Medline Industries, LP
Medline Industries, LP holds 267 FDA 510(k) clearances across 107 product codes. Median elapsed review time is 116 days. openFDA lists 616 recall records naming the company. FDA publishes it under 13 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 267
- Product codes
- 107
- Median review
- 116 days
- Recall records
- 616
How does FDA spell Medline Industries, LP?
FDA publishes this company under 13 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| MEDLINE INDUSTRIES INC | device/enforcement | normalised |
| MEDLINE INDUSTRIES INC | device/recall | normalised |
| Medline Industries Inc | device/enforcement | normalised |
| Medline Industries Inc | device/recall | normalised |
| Medline Industries Inc. | device/recall | normalised |
| Medline Industries Inc. | device/enforcement | normalised |
| Medline Industries, Inc. | device/510k | normalised |
| Medline Industries, Inc. | device/recall | normalised |
Showing 8 of 13.
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Medline Industries, LP file in?
107 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| FYA | Gown, Surgical | 16 | 126 days | |
| LZA | Polymer Patient Examination Glove | 13 | 137 days | |
| KGO | Surgeon'S Gloves | 12 | 150 days | |
| FRG | Wrap, Sterilization | 11 | 240 days | |
| FRO | Dressing, Wound, Drug | 9 | 181 days | |
| INI | Vehicle, Motorized 3-Wheeled | 9 | 32 days | |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 8 | 109 days | |
| LYY | Latex Patient Examination Glove | 8 | 102 days | |
| HRS | Plate, Fixation, Bone | 6 | 113 days | |
| KKX | Drape, Surgical, Antimicrobial | 6 | 132 days | |
| FMQ | Restraint, Protective | 5 | 53 days | |
| HWC | Screw, Fixation, Bone | 5 | 80 days | |
| KNT | Tubes, Gastrointestinal (And Accessories) | 5 | 46 days | |
| KOD | Catheter, Urological | 5 | 20 days | |
| LRO | General Surgery Tray | 5 | 136 days | |
| LYZ | Vinyl Patient Examination Glove | 5 | 83 days | |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 4 | 182 days | |
| FMF | Syringe, Piston | 4 | 72 days | |
| JDR | Staple, Fixation, Bone | 4 | 43 days | |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 4 | 56 days | |
| CAF | Nebulizer (Direct Patient Interface) | 3 | 266 days | |
| DQO | Catheter, Intravascular, Diagnostic | 3 | 294 days | |
| DXQ | Blood Pressure Cuff | 3 | 173 days | |
| EZL | Catheter, Retention Type, Balloon | 3 | 114 days | |
| FLL | Continuous Measurement Thermometer | 3 | 110 days |
Showing the 25 they file in most, of 107.
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 Medline Industries, LP had a recall?
openFDA lists 616 recall records naming this company across its whole history, of which 473 were opened in the last 12 months and are not yet marked terminated. A recall record covers one firm's corrective action and may span many device lots.
Z-2788-2026Class IIOpen, ClassifiedOEZ
Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.
Z-2789-2026Class IIOpen, ClassifiedLRO
Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.
Z-2790-2026Class IIOpen, ClassifiedOJG
Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.
Z-2791-2026Class IIOpen, ClassifiedOJH
Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.
Z-2736-2026Class IIOpen, ClassifiedLRO
Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of product include clinically insignificant extension of surgery to find another readily available device.
Showing the 5 most recently initiated of 616.
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 Medline Industries, LP cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K254287 | Medline Reusable Blood Pressure Cuff | DXQ | 173 | |
| K253322 | Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78 Infant Circuit, HUD99060KIT / Dri-Tech with 78 Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60 Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44 Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel) | BZE | 176 | |
| K251687 | Konig Bell Circumcision Clamp | HFX | 268 | |
| K253070 | Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL) | DXC | 58 | |
| K250345 | Medline Bag Decanter | LHI | 260 | |
| K250312 | Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small | BTT | 149 | |
| K243888 | Medline UNITE® REFLEX® Hybrid Nitinol Implant System | JDR | 114 | |
| K242844 | Medline Level 4 Surgical Gown with Breathable Sleeves | FYA | 159 | |
| K242370 | Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A)) | GEI | 132 | |
| K241778 | Hudson RCI Comfort Flo® CubCannula | BTT | 182 |
Source: openFDA device/510k · retrieved
Where is Medline Industries, LP registered?
FDA lists 2 registered establishments for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what Medline Industries, LP files next
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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.