ClearanceBrief
Company

Sklar Instruments

FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.

0510(k) clearances (0 in 12 months)
30recalls (0 in 12 months)
6recalls that name a 510(k)

Product codes

CodeDeviceRecords
EPYSpeculum, Ent1
FBXSound, Urethral, Metal Or Plastic1
FFORetractor, Self-Retaining1
FZSCurette, Surgical, General Use1
FZTCutter, Surgical1
GADRetractor1
GAFSpatula, Surgical, General & Plastic Surgery1
GDGHook, Surgical, General & Plastic Surgery1
GDJClamp, Surgical, General & Plastic Surgery1
GDZHandle, Scalpel1
GEACannula, Surgical, General & Plastic Surgery1
GENForceps, General & Plastic Surgery1
HCYCurette, Uterine1
HDFSpeculum, Vaginal, Metal1
HDLRetractor, Vaginal1
HDQDilator, Cervical, Fixed Size1
HFBForceps, Biopsy, Gynecological1
HHFRemover, Intrauterine Device, Contraceptive, Hook-Type1
HNCSpecula, Ophthalmic1
HNFScissors, Ophthalmic1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
No clearances in this window.

Latest recalls

DateFirm and productCodeLinked 510(k)
Jan 16, 2025Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE OLSEN-HEG NH SMO DEL 5.5STER25, Model Number 96-2352A; 2) ECONO STERILE HALSEY NH SERR 5" STRL CS/25, Model Number 96-2353; 3) E
Open, Classified
HXKNone listed
Jan 16, 2025Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE PROBE W/EYE CS/50, Model Number 94-5923; 2) ECONO STERIL" PROBE W/EYE 5.5" STERL CS/25, Model Number 96-2361; orthopedic probe
Open, Classified
HXBNone listed
Jan 16, 2025Sklar Instruments
ECONO STERILE medical procedure kits labeled as: ECONO STERILE LEMPERT BONE RONG 6.25" STER25, Model Number 96-4780A; orthopedic surgery
Open, Classified
HTXNone listed
Jan 16, 2025Sklar Instruments
ECONO STERILE medical procedure kits labeled as: ECONO STERILE IRIS HOOK QK REL 4MM 9" STER25, Model Number 96-2224A; eye surgery
Open, Classified
HNQNone listed
Jan 16, 2025Sklar Instruments
Medical procedure kits labeled as: 1) ECONO STERILE STRABIS SCISS STR 4.5"STER 50, Model Number 96-2540; 2) ECONO STERILE STRABIS SCISS CVD 4.5"STER 50, Model Number 96-2541; 3) ECONO STERILE STRA
Open, Classified
HNFNone listed
Jan 16, 2025Sklar Instruments
ECONO STERILE medical procedure kits labeled as: ECONO STERILE ALFONSO INFANT SPEC STRL CS/10, Model Number 96-3814; eyelid surgery
Open, Classified
HNCNone listed
Jan 16, 2025Sklar Instruments
ECONO STERILE medical procedure kits labeled as: ECONO STERILE IUD EXTRACTOR DBL HK 10.5"CS25, Model Number 96-4146A
Open, Classified
HHFK772229
Jan 16, 2025Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE MINI TISCH 2.3X4.2MM STER CS10, Model Number 96-4134M; 2) ECONO STERILE OVAL BIOPSY FCP 3X7MM STER10, Model Number 96-4137M; gynec
Open, Classified
HFBK772229
Jan 16, 2025Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE HEGAR DILATOR 11&12MM STRLCS25Model Number 96-0960; 2) ECONO STERILE HEGAR DILATOR 9&10MM STRL CS25Model Number 96-0961; 3) ECONO
Open, Classified
HDQK772229
Jan 16, 2025Sklar Instruments
ECONO STERILE medical procedure kits labeled as: ECONO STERILE KOGAN ENDOCERV SPEC STER CS/5, Model Number 96-4142A, gynecological procedures
Open, Classified
HDLNone listed
Jan 16, 2025Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE GRAVES SPEC STRL SM BX/25, Model Number 96-2603; 2) ECONO STERILE GRAVES SPEC STRL MD BX/25, Model Number 96-2605; 3) ECONO STER
Open, Classified
HDFNone listed
Jan 16, 2025Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE SIMS UTERINE CURETTE #3 STER25, Model Number 96-4113; 2) ECONO STERILE KEVORK ENDO CURET W/BAS STER25, Model Number 96-4144A; 3) E
Open, Classified
HCYK772229
K802458
Jan 16, 2025Sklar Instruments
ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCHAMBERG EXTRCT SQ STER CS25, Model Number 96-2395M; blackhead extractor
Open, Classified
MDMNone listed
Jan 16, 2025Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE IRIS SCISS 4 1/2" CVD CASE/50,Model Number 941-0918; 2) ECONO STERILE METZENBAUM SCIS STR 9"STER C25,Model Number 941-1556; 3) ECO
Open, Classified
LRWNone listed
Jan 16, 2025Sklar Instruments
ECONO STERILE medical procedure kits labeled as: ECONO STERILE BLAKE GALLSTONE FCP CVD 8"CS25, Model Number 96-4921A
Open, Classified
HTDK012660
Jan 16, 2025Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ROCH-PEAN FCP 8" CVD CS/25,Model Number 94-0286; 2) ECONO STERILE DRESSING FCP 5.5" CS/25LG,Model Number 94-0290; 3) ECONO STERIL
Open, Classified
GENK772229
K801273
Jan 16, 2025Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE YANKAUER SUCTION TUBE 8.5" C10, Model Number 96-4176; 2) ECONO STERILE YANKAUER SUCTION TUBE 11" CS10, Model Number 96-4177; 3) EC
Open, Classified
GEANone listed
Jan 16, 2025Sklar Instruments
ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCALPEL HDL #3 W/METRIC CS/25, Model Number 96-3500M
Open, Classified
GDZNone listed
Jan 16, 2025Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE BACKHAUS TWL CLP STER 3.5 CS50, Model Number 96-2630; 2) ECONO STERILE BACKHAUS TWL CLP STER 5.25 25, Model Number 96-2636; general
Open, Classified
GDJNone listed
Jan 16, 2025Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VEIN HOOK 1.5MM STERILE CS/25, Model Number 96-4020M; 2) ECONO STERILE VEIN HOOK 2MM STERILE CS/25, Model Number 96-4021M; 3) ECON
Open, Classified
GDGNone listed
Jan 16, 2025Sklar Instruments
ECONO STERILE medical procedure kits labeled as: ECONO STERILE CEMENT SPATULA #24 STRL CS/25, Model Number 96-2245M, mixing utensil, dental
Open, Classified
GAFNone listed
Jan 16, 2025Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ARMY RETR (SET OF 2) STER CS25, Model Number 96-2243; 2) ECONO STERILE ARMY RETR (SET OF 2)STRL CS/25, Model Number 96-2243M; 3) E
Open, Classified
GADNone listed
Jan 16, 2025Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE D/A NAIL NIPPER 5.75" STER CS5, Model Number 96-2424A; 2) ECONO STERILE TISS NIPPER 14MM CVX 5"CS/25, Model Number 96-2427; 3) ECO
Open, Classified
FZTNone listed
Jan 16, 2025Sklar Instruments
ECONO STERILE medical procedure kits labeled as: ECONO STERILE" CURETTE EXCAVATOR STRL CS/25, Model Number 941-1320; general surgical
Open, Classified
FZSNone listed
Jan 16, 2025Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2236; 2) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2237M; 3) ECO
Open, Classified
EPYNone listed
Jan 16, 2025Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE WEITLANER RETR SH 2X3 4.5"CS25, Model Numbers: 96-2201A; 2) ECONO STERILE WEITLANER RETR BL 2X3 4.5"CS25, Model Numbers: 96-2203A
Open, Classified
FFONone listed
Jan 16, 2025Sklar Instruments
ECONO STERILE medical procedure kits labeled as: ECONO STERILE SIMS UTERINE SND GRD 13"STER25, Model Numbers: 96-2478 (gynecological use)
Open, Classified
FBXNone listed
Jan 16, 2025Sklar Instruments
ECONO STERILE medical procedure kits labeled as: ECONO STERILE TROUSSEAU DILATOR CS/25, Model Number 941-0191 (tracheal procedures)
Open, Classified
KCGNone listed
Jan 16, 2025Sklar Instruments
ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE FREER ELEV DE S/B 7.25" CS/25, Model Number 96-2483 (multiple purpose); 2) ECONO STERILE LOCKE ELEV #94 NARROW STER 25, Mode
Open, Classified
KADNone listed
Jan 16, 2025Sklar Instruments
ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE" BUCK EAR CUR BL STR#0STRLCS/25, Model Number 96-2273; 2) ECONO STERILE" BILLEAU EAR LOOP MD STRL CS/25, Model Number 96-228
Open, Classified
JYGNone listed
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