Atlas FDA

HAO

34 FDA 510(k) clearances · Product code

25 daysmedian time to decision
62 days90th percentile
34clearances measured

FDA profile

Official device name
Instrument, Surgical, Non-Powered
Device class
Class I (low risk)
Regulation
21 CFR 882.4535
Medical specialty
Neurology
Adverse events (MAUDE)
2013: 6 · 2014: 12 · 2015: 67 · 2016: 55 · 2017: 26 · 2019: 19
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Matreneu Percutaneous Balloon Compression Kit (K220920)Shenzhen Shineyard Medical Device Co. , Ltd.2022-09-07
MULLAN GANGLION MICROCOMPRESSION SET (K940973)Cook, Inc.1995-09-29
RIB RESECTOR (K951492)United States Surgical, A Division of Tyco Healthc1995-05-18
AUTO SUTURE PITUITARY SPINAL RONGEUR (K943115)United States Surgical, A Division of Tyco Healthc1994-07-25
AUTO SUTURE SPINAL DISSECTOR (K942971)United States Surgical, A Division of Tyco Healthc1994-07-20
AUTO SUTURE SPINAL CURETTE (K942967)United States Surgical, A Division of Tyco Healthc1994-07-20
AUTO SUTURE SPINAL ELEVATOR (K942970)United States Surgical, A Division of Tyco Healthc1994-07-20
AUTO SUTURE SPINAL OSTEOTOME (K942968)United States Surgical, A Division of Tyco Healthc1994-07-20
AUTO SUTURE SPINAL NERVE HOOK (K942969)United States Surgical, A Division of Tyco Healthc1994-07-20
SILICONE BRAIN SPATULA SET (K923723)Redmond Neurosurgical, Inc.1992-08-12
BONE PAD REMOVER (K910225)Acra Cut, Inc.1991-02-12
DURAL DISSECTORS (K910226)Acra Cut, Inc.1991-02-12
ZEPPELIN INSTRUMENTS (K902850)Ruggles Corp.1990-07-18
TAYLOR SPINAL RETRACTOR (K892546)Zinnanti Surgical Instruments, Inc.1989-05-11
DISPOSABLE ARACHNOID KNIFE (K882422)Microbio-Medics, Inc.1988-09-06
MALLEABLE PTFE COATED BRAIN SPATULAE (K880278)Downs Surgical , Ltd.1988-02-11
FORCEPS CLIPRACK VENTRICULAR CANNULA SAWS SPATULAS (K874962)Solway, Inc.1988-02-02
RANGE OF TITANIUM NEUROSURGERY INSTRUMENTS (K874630)Downs Surgical , Ltd.1987-12-23
RAYLOR MINI-PROBE (K863416)Cedar Surgical, Inc.1986-09-24
RAYLOR BONE IMPACTORS (K863415)Cedar Surgical, Inc.1986-09-24
FUJITSU MALLEABLE - TIP BRAIN SPATULA (K862331)Downs Surgical , Ltd.1986-07-01
NEUROSURGICAL INSTURMENTS (VARIOUS) (K861630)Downs Surgical , Ltd.1986-05-09
DERMALAND DURAL HOOKS (K832343)National Fabtronix, Inc.1983-08-12
H-H NERVE ROOT RETRACTOR (K822048)Holter-Hausner Intl.1982-07-22
MODIFIED NEURO SURGERY NIBBLING FORCEPS (K821357)Downs Surgical , Ltd.1982-05-14
INSTRUMENTS NONSTERILE & STERILE (K802726)Ascep, Inc.1980-11-19
FIELD-LEE BRAIN BIOPSY NEEDLE (K801760)American V. Mueller1980-09-09
SUBCUPASS TUNNELING TOOL (K780579)Medtronic Vascular1978-05-19
VAS APPROXIMATOR (K780520)Edward Weck, Inc.1978-05-16
BAYONET SURGICAL INSTRUMENTS (K772371)Edward Weck, Inc.1978-01-06
DANDY HEMOSTATIC FORCEPS (K772389)Edward Weck, Inc.1978-01-06
PERCUPASS TUNNELING TOOL MODEL 3452 (K772013)Medtronic Vascular1977-10-28
VANDERBILT CURETTE (K761095)Codman & Shurtleff, Inc.1976-11-30
VANDERBILT BLADE HOLDER (K761097)Codman & Shurtleff, Inc.1976-11-30

Track HAO automatically

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