Atlas FDA

GFA

27 FDA 510(k) clearances · Product code

41 daysmedian time to decision
233 days90th percentile
27clearances measured

FDA profile

Official device name
Blade, Saw, General & Plastic Surgery, Surgical
Device class
Class I (low risk)
Regulation
21 CFR 878.4820
Medical specialty
General, Plastic Surgery
Adverse events (MAUDE)
2021: 394 · 2022: 442 · 2023: 383 · 2024: 501 · 2025: 385 · 2026: 237
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
GRAFT HARVESTING SAWBLADES (K971978)Wrightmedicaltechnologyinc1997-06-18
STRYKER SAGITTAL SAW ATTACHMENT (K954483)Stryker Instruments1996-01-30
WRIGHT MEDICAL TECHNOLOGY SAWBLADES (K955229)Wrightmedicaltechnologyinc1996-01-18
DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS (K953012)Boston Surgical Products, Inc.1995-07-12
SURGICAL SAW BLADES (K950403)Transidyne General Corp.1995-02-21
RE-SHARPENABLE SAW BLADES (K940501)Adven Medical1994-06-28
BUR, SURGICAL, GENERAL & PLASTIC SURGERY (K933595)Omega Surgical Instruments, Inc.1994-03-16
SARNS STERNAL SAW II, STERNAL SAW II BLADE, SARNS SAW BLADES-NON-STERILE BULK PACK (K935391)3M Health Care, Sarns1994-02-24
SURGICAL SAW BLADES (K934603)American Medical Specialties, Inc.1994-02-22
SNAP OSCILLATING SAW (K931769)Surgiquip, Inc.1994-01-27
OSCILLATING BONE SAW BLADE, 6200 SERIES (K934390)Boehringer Laboratories1994-01-26
INTERMEDICS ORTHOPEDICS SAW BLADE (K931210)Intermedics Orthopedics1993-11-18
SAW BLADE (K933298)Omega Surgical Instruments, Inc.1993-08-09
FLUID COOLED BONE SAW BLADE, 6000 SERIES (K924953)Boehringer Laboratories1993-01-21
SURGICAL SAW BLADES (K912761)Blairden Precision Instruments, Inc.1991-07-19
MICRO-AIRE OSCILLATING SAW BLADE 202C-25, 202C-50 (K896280)Micro-Aire Surgical Instruments, Inc.1989-11-22
SAWBLADE (K863788)Tava Surgical Instruments1986-10-14
CRANIO BLADES AND WIRE PASS DRILL (K861876)New England Surgical Instrument Corp.1986-05-30
ANADIAS NASAL SAW BLADES (K854192)Anadias, Inc.1985-11-13
BRIMFIELD SCIEN. INSTRU. DISPOS. STERILE SURG. BLA (K851880)J-Pac, LLC1985-05-21
MICRO-AIRE REPLACEMENT SURG. SAW BLADE (K831714)Micro-Aire Surgical Instruments, Inc.1983-07-07
DISPOSABLE INTRA-ARTICULAR BLADE (K830434)Concept, Inc.1983-04-12
MICRO-SURGICAL POWER INSTRUMENT SYS. (K821487)Spire Medical, Inc.1982-07-02
REPLACEMENT SAW BLADES FOR STRYKER AIR (K820601)Micro-Aire Surgical Instruments, Inc.1982-03-23
MICRO-AIRE REPLACEMENT SAW BLADES (K811506)Micro-Aire Surgical Instruments, Inc.1981-08-13
I.M. RETROGRADE BLADES (K810045)Hogan & Hartson1981-02-12
STERNUM SAW BLADE (K802838)Amsco Co.1980-12-11

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