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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
123337–123360 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 11, 1990
FIXATION STAPLE
K905363 · JDR
O'Tec Corp.
Orthopedic · 13d
Cleared Dec 11, 1990
ROUND STAPLE
K905364 · JDR
O'Tec Corp.
Orthopedic · 13d
Cleared Dec 10, 1990
TSRH SPINAL SYSTEM (ADD'L SIZES OF HOOKS)
K901005 · KWP
Danek Medical, Inc.
Orthopedic · 283d
Cleared Dec 10, 1990
KNIGHT SACRAL SCREW
K902775 · KWP
Danek Medical, Inc.
Orthopedic · 168d
Cleared Dec 10, 1990
THERA-MIST TM VOLUMINA INCENT SPIROMETER, P40000
K903489 · BWF
Pegasus Research Corp.
Anesthesiology · 130d
Cleared Dec 10, 1990
INSULATED ELECTRODES AND LAPAROSCOPIC PROBICS
K904173 · HET
Baxter Healthcare Corp
Obstetrics & Gynecology · 90d
Cleared Dec 10, 1990
VESSEL DILATOR
K904476 · DRE
Datascope Corp.
Cardiovascular · 70d
Cleared Dec 10, 1990
MODEL CA.150 CELLULOSE ACETATE HOLLOW FIBER DIALYZ
K905228 · FJI
Baxter Healthcare Corp
Gastroenterology & Urology · 20d
Cleared Dec 07, 1990
VARICOSCREEN(TM)
K900404 · KYA
Promedex, Inc.
Radiology · 312d
Cleared Dec 07, 1990
CHILDRENS SUNGLASSES
K902225 · HQY
Jasco Products Co., Inc.
Ophthalmic · 204d
Cleared Dec 07, 1990
MODIFIED CASS SYSTEM
K902488 · KXK
Medical Instrumentation & Diagnostics...
Radiology · 191d
Cleared Dec 07, 1990
LDL-DIRECT CONTROLS
K902740 · JJY
Isolab, Inc.
Chemistry · 168d
Cleared Dec 07, 1990
BRACKET, METAL, ORTHODOTNIC
K902809 · EJF
Masel Industries, Inc.
Dental · 163d
Cleared Dec 07, 1990
ENDOSCOPIC LIGHT SOURCE 250 ENDO
K903790 · FCW
Orlux Engineering and Instrumentation
Gastroenterology & Urology · 109d
Cleared Dec 07, 1990
SURGILASE SL 50/60 GOLD SURGICAL LASER SYSTEM
K904203 · GEX
Surgilase, Inc.
General & Plastic Surgery · 86d
Cleared Dec 07, 1990
PAROJECT ANESTHETIC SYRINGE
K904279 · EGM
Ronvig Instruments, Ltd.
Dental · 81d
Cleared Dec 07, 1990
TURBO-RAST SPECIFIC IGE ASSAY
K904330 · DHB
Ventrex Laboratories, Inc.
Immunology · 78d
Cleared Dec 07, 1990
KLEARTEX LATEX SURGEONS GLOVES
K904361 · KGO
Kleartex Sdn Bhd
General Hospital · 74d
Cleared Dec 07, 1990
BATTERY-POWERED TOOTHBRUSH
K904401 · JEQ
The B & F System, Inc.
Dental · 73d
Cleared Dec 07, 1990
NIDEK INC. MODEL AC-2000 DERM
K904402 · GEX
Nidek, Inc.
General & Plastic Surgery · 73d
Cleared Dec 07, 1990
HEARING AID, UNITRON MODEL UM60-UH
K904576 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 59d
Cleared Dec 07, 1990
CONQUEST DIRECT FILLING COMPOSITE (DFC)
K904724 · KLE
Jeneric/Pentron, Inc.
Dental · 51d
Cleared Dec 07, 1990
QUALITONE ULTRA CANAL GENESIS
K904730 · ESD
Qualitone
Ear, Nose, Throat · 51d
Cleared Dec 07, 1990
INGLAT-O-BALL
K904774 · HHW
Milex Products, Inc.
Obstetrics & Gynecology · 46d