HXB
15 FDA 510(k) clearances · Product code
27 daysmedian time to decision
93 days90th percentile
15clearances measured
FDA profile
- Official device name
- Probe
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Medical specialty
- Orthopedic
- Adverse events (MAUDE)
- 2021: 35 · 2022: 41 · 2023: 47 · 2024: 36 · 2025: 37 · 2026: 23
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| DIAO HAND SURGERY SET (K960539) | Kinetikos Medical, Inc. | 1996-07-23 |
| COHORT AVB RETRACTOR SYSTEM (K943472) | Cohort Medical Products Group, Inc. | 1994-10-20 |
| FLEXMEDICS RETRACT ORTH PROBE, PETTINE BONE PROBE (K912843) | Flexmedics | 1991-09-24 |
| SURGICAL PROBE (K890227) | Kinetic Medical Products | 1989-01-27 |
| HOOK PROBE #TM-1376 (K873652) | Arthropedics, Inc. | 1987-11-02 |
| BLUNT MEASURING PROBE W/2MM GRADATIONS #TM-1375 (K873651) | Arthropedics, Inc. | 1987-11-02 |
| BOWEN PROBE (K863149) | Bowen & Company, Inc. | 1986-09-05 |
| 2.5MM & 4MM PROBE K841969-LABELING (K841971) | Stainless Mfg., Inc. | 1984-06-19 |
| SHUTT PRECISION PROBES (K840558) | Concept, Inc. | 1984-04-25 |
| LINE CADDY (K810294) | Instranetics, Inc. | 1981-02-26 |
| I.M PROBES (K802951) | Hogan & Hartson | 1980-12-17 |
| SURGICAL KNIVES & PROBES (K802479) | Eder Instrument Co, Inc. | 1980-10-31 |
| PROBE (K800729) | Stainless Mfg., Inc. | 1980-04-08 |
| GOLDEN RETRIEVERS OR SILVER RETRIEVERS (K800444) | Instrument Makar, Inc. | 1980-03-05 |
| ACUFEX PROBES (K800274) | Acufex Microsurgical, Inc. | 1980-02-19 |
Track HXB automatically
Every clearance here is in the API, with alerts when new ones post.