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
95977–96000 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 18, 1996
FLEXART TMJ COIL
K961624 · LNH
Toshiba America Mri, Inc.
Radiology · 175d
Cleared Oct 18, 1996
RESPIRGARD II, SPIROGARD
K961838 · CAH
Marquest Medical Products, Inc.
General Hospital · 158d
Cleared Oct 18, 1996
AQ HYDROPHILIC DILATORS
K961904 · KOE
Cook Urological, Inc.
Gastroenterology & Urology · 155d
Cleared Oct 18, 1996
3I SINGLE USE, DISPOSABLE DRILLS,TAPS,BURS, ETC.
K962014 · DZE
Implant Innovations, Inc.
Dental · 148d
Cleared Oct 18, 1996
TPP
K962176 · MIF
Panbio, Inc.
Hematology · 135d
Cleared Oct 18, 1996
OLYMPUS C3 IMMUNOTURBIDIMETRIC REGENT
K962409 · CZW
Olympus America, Inc.
Immunology · 119d
Cleared Oct 18, 1996
OLYMPUS C4 IMMUNOTURBIDIMETRIC REAGENT
K962582 · DBI
Olympus America, Inc.
Immunology · 109d
Cleared Oct 18, 1996
DUAL INTEGRATOR DENTAL IMPLANT ACCESSORIES
K962610 · DZE
Implant Integration Systems, Inc.
Dental · 107d
Cleared Oct 18, 1996
THE INCH QUILTED LIMB HOLDER WITH QUICK RELEASE SNAP CLOSURE
K962831 · FMQ
Heelbo, Inc.
General Hospital · 88d
Cleared Oct 18, 1996
HEELBO QUILTED LIMB HOLDER WITH DOUBLE D-RING AND STRAP
K962832 · FMQ
Heelbo, Inc.
General Hospital · 88d
Cleared Oct 18, 1996
HEELBO QUILTED LIMB HOLDER WITH DOUBLE D-RING, QUICK-RELEASE SNAP, AND STRAP
K962834 · FMQ
Heelbo, Inc.
General Hospital · 88d
Cleared Oct 18, 1996
HEELBO QUILTED LIMB HOLDER WITH BUCKLE AND STRAP
K962839 · FMQ
Heelbo, Inc.
General Hospital · 88d
Cleared Oct 18, 1996
REPLACE TPS COATED IMPLANTS
K962844 · DZE
Steri-Oss, Inc.
Dental · 88d
Cleared Oct 18, 1996
REPLACE HA COATED IMPLANTS
K962845 · DZE
Steri-Oss, Inc.
Dental · 88d
Cleared Oct 18, 1996
MIDWEST 300 SE
K962877 · EFB
Midwest Dental Products Corp.
Dental · 86d
Cleared Oct 18, 1996
INTERLINK ADAPTER FOR CONVENTIONAL Y-SITE
K962893 · FPA
Baxter Healthcare Corp
General Hospital · 85d
Cleared Oct 18, 1996
VITROS IMMUNODIAGNOSTIC SYSTEM
K962919 · KHO
Johnson & Johnson Clinical...
Chemistry · 84d
Cleared Oct 18, 1996
DELTEC SUBCUTANEOUS INFUSION SET
K963009 · FPA
Sims Deltec, Inc.
General Hospital · 77d
Cleared Oct 18, 1996
CLAMPLESS VALVED CATHETER-PICC (CVC-PICC)
K963097 · LJS
Bmw Medical, Inc.
General Hospital · 70d
Cleared Oct 18, 1996
ADVANTAGE WINDOWS TISSUE VOLUME OPTION
K963345 · LNH
GE Medical Systems
Radiology · 53d
Cleared Oct 18, 1996
LYSOL I.C. BRAND PHENOLIC DISINFECTANT CLEANER (EPA REG. NO. 675-46)
K963353 · LRJ
Reckitt Benckiser, Inc.
General Hospital · 53d
Cleared Oct 18, 1996
MEDLINE BODY HOLDER
K963360 · FMQ
Medline Industries, Inc.
General Hospital · 53d
Cleared Oct 18, 1996
MEDLINE SAETY VEST,MEDLINE ECONOMY VEST, MEDLINE TIE-BACK VEST, MEDLINE...
K963362 · FMQ
Medline Industries, Inc.
General Hospital · 53d
Cleared Oct 18, 1996
MEDLINE PELVIC HOLDER
K963404 · FMQ
Medline Industries, Inc.
General Hospital · 50d