Medical device manufacturer
Buckman Co., Inc.
Buckman Co., Inc. holds 111 FDA 510(k) clearances across 65 product codes. Median elapsed review time is 64 days. openFDA lists no recall records naming the company.
Updated · ingest status · JSON
- 510(k) clearances
- 111
- Product codes
- 65
- Median review
- 64 days
- Recall records
- 0
How does FDA spell Buckman Co., Inc.?
FDA publishes this company under a single spelling, so nothing needed merging here. Many manufacturers are not so tidy.
Which product codes does Buckman Co., Inc. file in?
65 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| BXB | Exerciser, Powered | 8 | 34 days | |
| HWC | Screw, Fixation, Bone | 8 | 34 days | |
| GEX | Powered Laser Surgical Instrument | 5 | 222 days | |
| KWP | Appliance, Fixation, Spinal Interlaminal | 5 | 211 days | |
| HSB | Rod, Fixation, Intramedullary And Accessories | 4 | 24 days | |
| JDW | Pin, Fixation, Threaded | 4 | 41 days | |
| HTN | Washer, Bolt Nut | 3 | 27 days | |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 3 | 328 days | |
| GKZ | Counter, Differential Cell | 2 | 391 days | |
| HRS | Plate, Fixation, Bone | 2 | 19 days | |
| HTY | Pin, Fixation, Smooth | 2 | 16 days | |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | 2 | 28 days | |
| HWJ | Awl | 2 | 11 days | |
| JDX | Instrument, Surgical, Sonic And Accessory/Attachment | 2 | 37 days | |
| JEC | Component, Traction, Invasive | 2 | 50 days | |
| JFA | Exerciser, Finger, Powered | 2 | 13 days | |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 2 | 56 days | |
| KTW | Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | 2 | 61 days | |
| LGF | Component, Cast | 2 | 10 days | |
| BZQ | Monitor, Breathing Frequency | 1 | 187 days | |
| CAN | Regulator, Pressure, Gas Cylinder | 1 | 244 days | |
| DSB | Plethysmograph, Impedance | 1 | 225 days | |
| DSH | Recorder, Magnetic Tape, Medical | 1 | 139 days | |
| DWC | Controller, Temperature, Cardiopulmonary Bypass | 1 | 130 days | |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 1 | 73 days |
Showing the 25 they file in most, of 65.
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 Buckman Co., Inc. 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 Buckman Co., Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K961320 | CROSS MEDICAL BONE PLATE SYSTEM/ CM BONE PLATE SYSTEM/CROSS TI BONE PLATE SYSTEM | HWC | 811 | |
| K974641 | FUTURELASE 3000/3002 ERBIUM LASER SYSTEM | GEX | 175 | |
| K964252 | ORTHOCHUCK | GEY | 215 | |
| K950099 | SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM | MNH | 737 | |
| K960451 | WEBB-MORLEY SPINE SYSTEM | MNH | 79 | |
| K950999 | KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS | MNH | 328 | |
| K945756 | IMAGN(TM) 2000 SYSTEM | GKZ | 391 | |
| K940003 | VOLUMET CD4 + AND CD8 + T LYMPHOCYTE COUNT TEST KIT | GKZ | 654 | |
| K951117 | LIHTAN 532 LASER | GEX | 222 | |
| K942751 | VANGUARD SERIES GAS REGULATORS | CAN | 244 |
Source: openFDA device/510k · retrieved
Watch what Buckman Co., 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.