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
85369–85392 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 18, 1999
DAILIES (NELFILCON A) ONE-DAY
K992446 · MVN
Ciba Vision Johns Creek Mfg.
Ophthalmic · 27d
Cleared Aug 18, 1999
CANTOR & SILVER 5X PROSTHETIC TINTED (HIOXIFILCON A) SOFT DAILY WEAR CONTACT...
K992500 · LPL
Cantor & Silver , Ltd.
Ophthalmic · 23d
Cleared Aug 17, 1999
KONICA DIRECT DIGITIZER, MODEL DD-341
K990359 · MQB
Konica Corp.
Radiology · 193d
Cleared Aug 17, 1999
TWO RIVERS POWER LIFT/RECLINE CHAIR
K991693 · INO
Two Rivers, LLC
Physical Medicine · 91d
Cleared Aug 17, 1999
MAXIM REMOVABLE MOLDED POLY TIBIA
K991753 · JWH
Biomet, Inc.
Orthopedic · 85d
Cleared Aug 17, 1999
SOMATOM PROJECT 10-CT SCANNERS
K991764 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 85d
Cleared Aug 17, 1999
MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR...
K991785 · BTL
Instrumentation Industries, Inc.
Anesthesiology · 84d
Cleared Aug 17, 1999
KMI WRIST FUSION SYSTEM
K991873 · HRS
Kinetikos Medical, Inc.
Orthopedic · 76d
Cleared Aug 17, 1999
MAMMOTOME HH HAND-HELD PROBE, VACUUM SET, CONTROL MODULE, HH HAND-HELD...
K991980 · KNW
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 64d
Cleared Aug 17, 1999
NEUROVIEW INSTRUMENT HOLDER, MODEL 300-33
K992006 · OCV
Integra Neurocare, LLC
Gastroenterology & Urology · 63d
Cleared Aug 17, 1999
GENERAL PURPOSE TRANSDUCER STANDOFF, BIOPSY TRANSDUCER STANDOFF, BI-PLANE...
K992152 · ITX
CIVCO Medical Instruments Co., Inc.
Radiology · 53d
Cleared Aug 17, 1999
TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE VERA GREEN, CONTAINS...
K992200 · LYY
Shen Wei (Usa), Inc.
General Hospital · 48d
Cleared Aug 17, 1999
BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING...
K992337 · FMC
Mexpo Intl., Inc.
General Hospital · 35d
Cleared Aug 17, 1999
IPASS BOLUS TRACKING
K992412 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 28d
Cleared Aug 17, 1999
EBI XFIX DFS OPTIROM ELBOW FIXATOR
K992515 · KTT
Ebi, L.P.
Orthopedic · 20d
Cleared Aug 16, 1999
BUFFALO FILTER VIROSAFE ERBIUM:YAG FILTER - #VSEYAG1-4 BUFFALO FILTER...
K983298 · FYD
Buffalo Filter Co., Inc.
General Hospital · 329d
Cleared Aug 16, 1999
MODIFICATION OF PROMPT L-POP
K992048 · KLE
Espe Dental AG
Dental · 60d
Cleared Aug 16, 1999
COLORSOFT PROSTHETIC TINTED SOFT CONTACT LENS
K992339 · LPL
Colorsoft Laboratories Corp.
Ophthalmic · 34d
Cleared Aug 13, 1999
UM-L20/ UM-L30
K982860 · GEX
Union Medical Engeneering Co., Ltd.
General & Plastic Surgery · 365d
Cleared Aug 13, 1999
ARTHREX MENISCAL DART SYSTEM
K983577 · MAI
Arthrex, Inc.
Orthopedic · 304d
Cleared Aug 13, 1999
BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL...
K984546 · FLD
Hemocleanse, Inc.
Gastroenterology & Urology · 234d
Cleared Aug 13, 1999
BURNFREE PAIN RELIEVING GEL, MODEL 4B
K990178 · MGQ
Nortrade Medical, Inc.
General & Plastic Surgery · 205d
Cleared Aug 13, 1999
BURNFREE 1/8 OZ. STERILE PAIN RELIEVING GEL, MODEL SD
K990179 · MGQ
Nortrade Medical, Inc.
General & Plastic Surgery · 205d
Cleared Aug 13, 1999
BURNFREE (4X4, 8X8, 16X24) STERILE BURN & WOUND DRESSING
K990180 · MGQ
Nortrade Medical, Inc.
General & Plastic Surgery · 205d