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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.

Product codes this company holds clearances in, with their median elapsed review time in each.
CodeDeviceClearancesMedian reviewLatest
BXBExerciser, Powered834 days
HWCScrew, Fixation, Bone834 days
GEXPowered Laser Surgical Instrument5222 days
KWPAppliance, Fixation, Spinal Interlaminal5211 days
HSBRod, Fixation, Intramedullary And Accessories424 days
JDWPin, Fixation, Threaded441 days
HTNWasher, Bolt Nut327 days
MNHOrthosis, Spondylolisthesis Spinal Fixation3328 days
GKZCounter, Differential Cell2391 days
HRSPlate, Fixation, Bone219 days
HTYPin, Fixation, Smooth216 days
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment228 days
HWJAwl211 days
JDXInstrument, Surgical, Sonic And Accessory/Attachment237 days
JECComponent, Traction, Invasive250 days
JFAExerciser, Finger, Powered213 days
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer256 days
KTWAppliance, Fixation, Nail/Blade/Plate Combination, Single Component261 days
LGFComponent, Cast210 days
BZQMonitor, Breathing Frequency1187 days
CANRegulator, Pressure, Gas Cylinder1244 days
DSBPlethysmograph, Impedance1225 days
DSHRecorder, Magnetic Tape, Medical1139 days
DWCController, Temperature, Cardiopulmonary Bypass1130 days
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass173 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?

Most recent 510(k) clearances for this company, newest first.
510(k)DeviceCodeDecisionElapsed days
K961320CROSS MEDICAL BONE PLATE SYSTEM/ CM BONE PLATE SYSTEM/CROSS TI BONE PLATE SYSTEMHWC811
K974641FUTURELASE 3000/3002 ERBIUM LASER SYSTEMGEX175
K964252ORTHOCHUCKGEY215
K950099SYNERGY(TM) TI POSTERIOR SPINAL SYSTEMMNH737
K960451WEBB-MORLEY SPINE SYSTEMMNH79
K950999KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESISMNH328
K945756IMAGN(TM) 2000 SYSTEMGKZ391
K940003VOLUMET CD4 + AND CD8 + T LYMPHOCYTE COUNT TEST KITGKZ654
K951117LIHTAN 532 LASERGEX222
K942751VANGUARD SERIES GAS REGULATORSCAN244

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.