Medical device manufacturer
Acumedia Manufacturers, Inc.
Acumedia Manufacturers, Inc. holds 177 FDA 510(k) clearances across 18 product codes. Median elapsed review time is 14 days. openFDA lists 8 recall records naming the company. FDA publishes it under 3 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 177
- Product codes
- 18
- Median review
- 14 days
- Recall records
- 8
How does FDA spell Acumedia Manufacturers, Inc.?
FDA publishes this company under 3 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 |
|---|---|---|
| Acumedia Manufacturers, Inc. | device/recall | normalised |
| Acumedia Manufacturers, Inc. | device/enforcement | normalised |
| Acumedia Manufacturers, Inc. | device/510k | normalised |
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 Acumedia Manufacturers, Inc. file in?
18 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| JSG | Culture Media, Non-Selective And Non-Differential | 42 | 11 days | |
| JSI | Culture Media, Selective And Differential | 40 | 17 days | |
| JSJ | Culture Media, Selective And Non-Differential | 30 | 11 days | |
| JSH | Culture Media, Non-Selective And Differential | 21 | 29 days | |
| JSK | Supplement, Culture Media | 10 | 15 days | |
| JSA | Culture Media, Antibiotic Assay | 8 | 10 days | |
| JSC | Culture Media, General Nutrient Broth | 6 | 16 days | |
| JSM | Culture Media, Non-Propagating Transport | 3 | 10 days | |
| JTY | Culture Media, For Isolation Of Pathogenic Neisseria | 3 | 10 days | |
| JSO | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar | 2 | 7 days | |
| JTZ | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | 2 | 11 days | |
| LKA | Culture Media, Antimicrobial Susceptibility Test | 2 | 38 days | |
| JAK | System, X-Ray, Tomography, Computed | 1 | 15 days | |
| JKS | Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide | 1 | 38 days | |
| JSD | Culture Media, Selective Broth | 1 | 16 days | |
| JSE | Culture Media, Multiple Biochemical Test | 1 | 41 days | |
| JSN | Culture Media, Propagating Transport | 1 | 7 days | |
| JSQ | Chromatography For Bacterial Identification | 1 | 11 days |
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 Acumedia Manufacturers, Inc. had a recall?
openFDA lists 8 recall records naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.
Z-0283-2019Class IIITerminatedJSI
Expiration date on the label is incorrect. Correct expiration date was November 30, 2020 and label on distributed product listed the expiration date as November 30, 2021.
Z-0284-2019Class IIITerminatedJSJ
The product is labeled with an incorrect expiration date.
Z-2221-2017Class IIITerminatedJSI
Storage temperature listed on the label was incorrect. Label stated 2-30C. Actual storage temperature is 2-8C.
Z-2212-2017Class IIITerminatedJSG
Storage temperature listed on the label was incorrect. Label stated 2-30C. Actual storage temperature is 2-8C.
Z-1093-2017Class IITerminatedJSG
light precipitate may form in prepared plates of Acumedia Tryptic Soy Agar (7100) Lot# 108166. While there is no change in growth performance of this medium, the formation of particulate matter may be misinterpreted as growth in poured plates thereby leading to inaccurate counts.
Showing the 5 most recently initiated of 8.
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 Acumedia Manufacturers, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K881579 | AMIES TRANSPORT MEDIUM W/O CHARCOAL | JSN | 7 | |
| K881578 | STREPTOSEL | JSJ | 7 | |
| K881577 | MODIFIED SELECTIVE STREPTOCOCCUS AGAR | JSI | 7 | |
| K881576 | SELENITE BROTH | JSI | 7 | |
| K881575 | SELECTIVE STREPTOCOCCUS AGAR | JSI | 7 | |
| K881574 | W-L DIFFERENTIAL MEDIUM | JSJ | 7 | |
| K881573 | PHYTONE YEAST EXTRACT AGAR | JSJ | 7 | |
| K881572 | XL AGAR BASE | JSI | 7 | |
| K881571 | YM BROTH | JSJ | 7 | |
| K881570 | SABOURAUD MALTOSE AGAR | JSJ | 7 |
Source: openFDA device/510k · retrieved
Watch what Acumedia Manufacturers, Inc. 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.