FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
84865–84888 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 13, 1999
SKIN 2 FORTE SILICONE SHEETING
K990651 · MDA
United Hospital Technologies, Inc.
General & Plastic Surgery · 165d
Cleared Aug 13, 1999
CONWAY STUART MODEL 100 IRRIGATION PUMP & ACCESSORIES
K990724 · GCJ
Conway Stuart Medical, Inc.
General & Plastic Surgery · 161d
Cleared Aug 13, 1999
PARAMED PARAFFIN WARMER
K991427 · IMC
Divi Intl. Co.
Physical Medicine · 112d
Cleared Aug 13, 1999
HALOLITE AAD SYSTEM WITH DEDICATED COMPRESSOR
K991685 · CAF
Medic-Aid , Ltd.
Anesthesiology · 88d
Cleared Aug 13, 1999
EBI OMEGA 21 SYSTEM
K991721 · MNI
Ebi Electro Biology
Orthopedic · 85d
Cleared Aug 13, 1999
DIGITAL VIDEO RECORDING SYSTEM
K991738 · LLZ
Kay Elemetrics Corp.
Radiology · 84d
Cleared Aug 13, 1999
ENDOSCOPIC SPINAL ACCESS SYSTEM
K991794 · HRX
Endius, Inc.
Orthopedic · 79d
Cleared Aug 13, 1999
EXPLORER 3D
K991815 · MUJ
Our Scientific Intl., Inc.
Radiology · 78d
Cleared Aug 13, 1999
PARALLAX TRACER RADIOPAQUE PARTICLES
K991893 · MYU
Parallax Medical, Inc.
Neurology · 71d