Atlas FDA

HQX

16 FDA 510(k) clearances · Product code

77 daysmedian time to decision
199 days90th percentile
16clearances measured

FDA profile

Official device name
Implant, Orbital, Extra-Ocular
Device class
Class II (moderate risk)
Regulation
21 CFR 886.3340
Medical specialty
Ophthalmic
Flags
Implant
Adverse events (MAUDE)
1996: 6 · 1997: 3 · 1998: 3 · 1999: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
MICROVISION SCLERAL BUCKLING COMPONENTS (K023481)Microvision, Inc.2003-01-08
OCU-GUARD AND OCU-GUARD SUPPLE (K983581)Bio-Vascular, Inc.1998-11-06
RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES (K980816)Fci Ophthalmics, Inc.1998-09-18
RETINAL DETACHMENT IMPLANTS; INCLUDING BANS, STRIPS, TIRES, SLEEVES, CORDS AND SPONGES (K963219)Fci Ophthalmics, Inc.1996-10-28
SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS (K950806)Mira, Inc.1996-06-05
STORS SCLERAL SPONGE II (LINCOFF DESIGN) (K950599)Storz Ophthalmics, Inc.1995-03-02
VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS (K945172)Visitec Co.1995-01-17
TAMCENAN OCULAR EXPLANTS AND BANDS (K902308)Tamcenan Corp.1990-06-19
O'DONNELL, SOCKET RECONSTRUCTION PROSTHESES (K901002)Oculo Plastik, Inc.1990-05-22
PUTTERMAN-SCOTT, SOCKET RECONSTRUCTION BILATERAL (K900929)Oculo Plastik, Inc.1990-05-18
COX MALAR EMINENCE IMPLANTS (K900928)Oculo Plastik, Inc.1990-05-15
CODERE-DURETTE ORBITAL FLOOR IMPLANT (K900927)Oculo Plastik, Inc.1990-05-15
SPIVEY-ALLEN ORBITAL FLOOR IMPLANT (K900930)Oculo Plastik, Inc.1990-05-15
POREX(TM) EXTRA-OCULAR ORBITAL IMPLANT (K863946)Porex Medical1987-02-27
SCLERAL BUCKLING IMPLANTS DIF/TYPES (K832481)Storz Instrument Co.1983-09-20
SILASTIC SCLERAL SPONGE II W/CIRCLING BD (K800140)Dow Corning Corp. Healthcare Industries Materials1980-03-03

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