FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
82465–82488 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 23, 2000
DISPOSABLE POWDERED NITRILE EXAM GLOVE, BLUE COLOR
K001065 · LZA
Sheen More Ent. Co., Ltd.
General Hospital · 50d
Cleared May 23, 2000
PROLENE SOFT (POLYPROPYLENE), NONABSORBABALE SYNTHETIC SURGICAL MESH
K001122 · FTL
Ethicon, Inc.
General & Plastic Surgery · 46d
Cleared May 23, 2000
NITRILE EXAM GLOVES, POWDER-FREE, COLOR BLUE
K001128 · LZA
Shanghai Poseidon Plastic Products...
General Hospital · 46d
Cleared May 23, 2000
DISPOSABLE POWDERED NITRILE EXAM GLOVE, WHITE COLOR
K001155 · LZA
Sheen More Ent. Co., Ltd.
General Hospital · 43d
Cleared May 23, 2000
POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE CONTAINS 50 MICROGRAMS OR...
K001190 · LYY
Kossan Latex Industries(M)Sdn Bhd
General Hospital · 41d
Cleared May 23, 2000
CONTINUUM KNEE SYSTEM-PS FEMORAL COMPONENTS- POROUS, MODEL XX-YYY-ZZZZZ
K001307 · JWH
Implex Corp.
Orthopedic · 29d
Cleared May 23, 2000
XIA SPINE SYSTEM HOOKS
K001319 · MNH
Howmedica Osteonics Corp.
Orthopedic · 27d
Cleared May 23, 2000
POWDERED LATEX EXAM GLOVES, PROTEIN LABELING (150 MICROGRAM OR LESS)
K001327 · LYY
Premier Pathway Sdn. Bhd.
General Hospital · 27d
Cleared May 23, 2000
EBI XFIX DFS METAPHYSEAL CORRECTION SYSTEM
K001358 · KTT
Ebi, L.P.
Orthopedic · 25d
Cleared May 23, 2000
HME-BOOSTER
K990614 · BTT
King Systems Corp.
Anesthesiology · 453d
Cleared May 23, 2000
NDD MEDICAL TECHNOLOGIES EASYONE SPIROMETER: FRONTLINE MODEL 2000 AND...
K993921 · BZG
Ndd Medical Technologies
Anesthesiology · 187d
Cleared May 23, 2000
VINYL PATIENT EXAMINATION GLOVES-POWDER FREE
K994098 · LYZ
Evergreen Medical Produts (Jingxing)...
General Hospital · 172d
Cleared May 23, 2000
NEER III TOTAL SHOULDER SYSTEM
K994350 · KWS
Smith & Nephew, Inc.
Orthopedic · 152d
Cleared May 23, 2000
GLOVETEX, LATEX EXAMINATION GLOVES, POWDERED NON-STERILE.(PROTEIN CONTENT...
K994426 · LYY
Pt. Wrp Buana Multicorpora
General Hospital · 145d
Cleared May 22, 2000
ETEST GATIFLOXACIN
K000596 · JWY
Ab Biodisk
Microbiology · 90d
Cleared May 22, 2000
THE APTUS (AUTOMATED) APPLICATION OF THE TG IGG ELISA TEST SYSTEM. AN ENZYME...
K000879 · LJM
Zeus Scientific, Inc.
Immunology · 63d
Cleared May 22, 2000
THE APTUS (AUTOMATED APPLICATION OF THE TPO IGG ELISA TEST SYSTEM. AN ENZYME...
K000880 · LJM
Zeus Scientific, Inc.
Immunology · 63d
Cleared May 22, 2000
GATIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K000930 · JTN
Oxoid , Ltd.
Microbiology · 61d
Cleared May 22, 2000
MULTISAFE POWDER-FREE PATIENT LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT...
K000999 · LYY
Multisafe Sdn. Bhd.
General Hospital · 55d
Cleared May 22, 2000
NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY
K993131 · LCP
Primus, Inc.
Hematology · 245d
Cleared May 22, 2000
VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210
K993319 · LGD
bioMerieux, Inc.
Microbiology · 231d
Cleared May 22, 2000
SPORTSIGHT GP
K993586 · HQD
Paragon Vision Sciences
Ophthalmic · 213d
Cleared May 19, 2000
MENICON Z
K000133 · HQD
Menicon U.S.A., Inc.
Ophthalmic · 122d
Cleared May 19, 2000
MENICON SF-P
K000233 · HQD
Menicon Co, Ltd.
Ophthalmic · 113d