Atlas FDA

HNR

44 FDA 510(k) clearances · Product code

29 daysmedian time to decision
94 days90th percentile
44clearances measured

FDA profile

Official device name
Forceps, Ophthalmic
Device class
Class I (low risk)
Regulation
21 CFR 886.4350
Medical specialty
Ophthalmic
Adverse events (MAUDE)
2021: 63 · 2022: 58 · 2023: 98 · 2024: 81 · 2025: 115 · 2026: 59
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
STEPHENS DISPOSABLE FORCEPS (K022835)Stephens Instruments2002-11-01
ALCON FOLDING FORCEPS (K895434)Alcon Laboratories1989-12-04
SOFT LENS FOLDING BLOCK (K891487)Western Medical Products, Inc.1989-08-15
PHACO-INJECTOR(TM) INTRAOCULAR LENS IMPLANT INSTR (K893199)Allergan Medical Optics1989-06-16
MCDONALD FOLDING FORCEPS (K885230)Alcon Laboratories1989-05-17
BRADBURY INTRAOCULAR RETINAL KIT CAT #200 (K881049)Microline Pentax, Inc.1988-09-12
IOL IMPLANTATION FORCEPS (K883197)D & D Surgical1988-08-22
ADVANCED SURGICAL PRODUCTS SCLERAL PLUG FORCEPS (K880274)Advanced Surgical Products, Inc.1988-02-05
OPHTHALMIC SURGICAL INSTRUMENTS (K864183)Techno Ophthalmics Intl.1986-11-28
OPHTHALMIC KNIFE & FORCEPS (K864266)Western Medical Products, Inc.1986-11-28
FAULKNER FORCEPS (K864071)Staar Surgical Co.1986-11-13
THORNTON TITANIUM FORCEPS (VARIOUS TYPES) (K863992)Keeler Instruments, Inc.1986-10-31
PACO-FOLDER (TM) INTRAOCULAR LENS FORCEPS (K864003)Allergan, Inc.1986-10-31
THORTON TITANIUM NEEDLEHOLDERS(NO,W CATCH & STAND (K863991)Keeler Instruments, Inc.1986-10-31
FIXATION INSTRUMENTS (K863727)Medical Technology Development Corp.1986-10-31
MANUAL OPHTHALMIC SURGICAL INSTRUMENTS (K861057)Precision-Cosmet Co., Inc.1986-04-24
MANUAL OPHTHALMIC SURGICAL INSTRUMENTS (K861141)CooperVision, Inc.1986-04-24
STORZ/MAZZACCO LENS FORCEP (K860915)Storz Instrument Co.1986-04-15
INTRAOCULAR FORCEPS & SCISSORS (K854869)Mira, Inc.1986-03-05
ASCON SURGICAL INSTRUMENTS (K852057)Ascon Medical Instruments, Ltd.1985-06-27
37-610 TO 37-880 VARIOUS OPHTHAL-FORCEPS (K851791)Artiberia1985-05-30
37-940 TO 37-944 VARIOUS NOYES OPHTHALMIC FORCEPS (K851792)Artiberia1985-05-30
PHARMASEAL EYE PREP TRAY (K850119)American Pharmaseal Div. Ahsc1985-05-09
SHURE GRIP TYING FORCEPS (K844129)Mentor O & O, Inc.1984-11-21
CILCOR OPHTHALMIC INSTRUMENTS (K843992)Cilco, Inc.1984-11-21
ROOTMAN ORBITAL SURGERY INSTRUMENT SET (K842697)Downs Surgical , Ltd.1984-08-07
MICRO FORCEPS (K834355)Jedmed Instrument Co.1984-03-16
MICROSURGICAL INSTRUMENTS (K823174)Concept, Inc.1982-11-16
ANIS LENS IMPLANT FORCEPS #2 (K811658)American V. Mueller1981-06-26
FISHER-PICKERING INTRAOCULAR EYE MAGNET (K803194)Storz Instrument Co.1981-02-04
GASKIN FRAGMENT FORCEPS(MFG. NON-STERILE (K801465)Edward Weck, Inc.1980-07-28
DODICK LENS HOLDING FORCEPS (K801467)Edward Weck, Inc.1980-07-28
OPHTHALMIC FORCEPS (K800368)Edward Weck, Inc.1980-03-12
FIX. & LENS FOR. #'S 3510,3512,3248,3795 (K791986)Edward Weck, Inc.1979-10-04
LIEBERMAN POLACK DOUBLE CORNEAL FORCEPS (K771003)Edward Weck, Inc.1977-06-17
SHEPARD LENS FORCEP W/ IRRIGATOR & LOCK (K770101)Edward Weck, Inc.1977-01-25
SHEPARD II, LENS FORCEP W/ LOCK (K770105)Edward Weck, Inc.1977-01-25
SHEPARD LENS FORCEP W/ IRRIGA W/OUT LOCK (K770099)Edward Weck, Inc.1977-01-24
BINKHORST LENS FORCEP W/ IRRIGATOR (K770100)Edward Weck, Inc.1977-01-24
HERSHMAN LENS FORCEPS WITH IRRIGATOR (K770097)Edward Weck, Inc.1977-01-24
HERSHMAN LENS FORCEPS W/OUT IRRIGATOR (K770102)Edward Weck, Inc.1977-01-24
BINKHORST LENS FORCEPS W/OUT IRRIGATOR (K770104)Edward Weck, Inc.1977-01-24
WECK TYING FORCEP, STRAIGHT TITANIUM (K761251)Edward Weck, Inc.1976-12-16
WECK TYING FORCEP, CURVED TITANIUM (K761252)Edward Weck, Inc.1976-12-16

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