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Prowess, Inc.

FDA Regulatory Profile

Prowess, Inc. appears in FDA public data with 0 recalls, 9 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent FDA inspection ended on Jun 2, 2026 (No Action Indicated (NAI)). Its most recent 510(k) clearance was granted on Dec 15, 2023.

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Summary

Total Recalls
0
510(k) Clearances
9
Inspections
4
Compliance Actions
0

Recent FDA Inspections

DateSiteProductClassificationFEI
Jun 2, 2026Concord, CADevicesNo Action Indicated (NAI)2939248
Nov 10, 2021Concord, CADevicesVoluntary Action Indicated (VAI)2939248
Jul 17, 2012Concord, CADevicesNo Action Indicated (NAI)2939248
Aug 11, 2010Concord, CADevicesNo Action Indicated (NAI)2939248

FDA Data Dashboard classifications: NAI (no action indicated), VAI (voluntary action indicated), OAI (official action indicated).

Recent 510(k) Clearances

K-NumberDeviceDate
K231825Panther TPSDec 15, 2023
K211760Panther OISSep 28, 2021
K193459Panther StereotacticApr 27, 2020
K143514Panther StereoSeedDec 11, 2015
K122616PANTHER OIS/R & V MODEL VERSION 2.0Dec 21, 2012
K101076PROWESS PANTHER PROARC, MODEL VERSION 5.0Jul 27, 2010
K100801PUMA MODEL VERSION 1.0Jun 18, 2010
K083502PANTHER REALART, MODEL 4.7May 5, 2009
K032456PROWESSOct 16, 2003

FDA data resources