Atlas FDA

HTZ

21 FDA 510(k) clearances · Product code

36 daysmedian time to decision
93 days90th percentile
21clearances measured

FDA profile

Official device name
Instrument, Cutting, Orthopedic
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Medical specialty
General, Plastic Surgery
Adverse events (MAUDE)
2021: 228 · 2022: 195 · 2023: 187 · 2024: 225 · 2025: 139 · 2026: 111
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
CEBOPLANE (K933933)Synvasive Technology, Inc.1994-04-15
HEDLEYL INTRAMEDULLARY PREPARATION BRUSH (K931737)Synvasive Technology, Inc.1994-01-07
45 DEGREE SHAVER (K870882)Bowen & Company, Inc.1987-03-23
KAMBIN SPINAL INSTRUMENT SET (K853678)Pilling Co.1985-09-24
CONCEPT SUCTION SLEEVE (K850423)Concept, Inc.1985-03-14
ARTHROSCOPY SUCTION BIOPSY PUNCH (K850527)T. Korossurgical Instruments Corp.1985-03-14
SIDE CUTTING SERRATED BLADE (K841980)Stainless Mfg., Inc.1984-08-15
CODMAN SUCTION PUNCH-PRODUCT CODES (K842774)Codman & Shurtleff, Inc.1984-07-27
ROSETTE KNIFE 4MM (K841975)Stainless Mfg., Inc.1984-06-19
LATERAL RELEASE KNIFE 5MM & 7MM (K841978)Stainless Mfg., Inc.1984-06-19
KOGAN ENDOSPECULUM 9-1/2 (K842111)J. Sklar Mfg. Co., Inc.1984-06-19
MENISCOTOME 4MM & 5MM (K841982)Stainless Mfg., Inc.1984-06-19
HOOK KNIFE 4MM & 5MM (K841976)Stainless Mfg., Inc.1984-06-19
RETROGRADE KNIFE 4MM & 5MM (K841974)Stainless Mfg., Inc.1984-06-19
BANANA KNIFE - K841969-LABELING (K841972)Stainless Mfg., Inc.1984-06-19
5MM DOUGLE EDGE RING CURETTE (K841977)Stainless Mfg., Inc.1984-06-19
BANANA KNIFE SERRATED (K841973)Stainless Mfg., Inc.1984-06-19
GUILLOTINE BLADE (K831772)Ortho Pared Instruments, Inc.1983-07-07
MICRO OSCILLATING SAW (K771915)American Sterilizer Co.1977-10-21
NEW PODIATRY PRODUCTS (K771005)Dentronix, Inc.1977-06-17
MODIFIED PODIATRY PRODUCTS (K771006)Dentronix, Inc.1977-06-17

Track HTZ automatically

Every clearance here is in the API, with alerts when new ones post.