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
117385–117408 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 22, 1992
NEEDLEGARD II
K920717 · FMI
Ingenious Technologies Corp.
General Hospital · 64d
Cleared Apr 22, 1992
MODIFICATION PROSPECT GIARDIA RAPID ASSAY
K920817 · MHI
Alexon, Inc.
Microbiology · 76d
Cleared Apr 22, 1992
BACTEC PLUS AEROBIC/F AND ANAEROBIC/F MEDIA
K921133 · MDB
Bd Becton Dickinson Vacutainer...
Microbiology · 43d
Cleared Apr 21, 1992
FETAL DOPPLER
K905536 · MAA
Toshiba America Medical Systems, In.C
Radiology · 497d
Cleared Apr 21, 1992
MODEL RD-1200 RUBY LASER SYSTEM
K910422 · GEX
Spectrum Medical Technologies, Inc.
General & Plastic Surgery · 447d
Cleared Apr 21, 1992
WILDE LIGHT CURING COMPOSITE RESTORATIVE RESINS
K913089 · EBF
Wilde-USA, Inc.
Dental · 284d
Cleared Apr 21, 1992
ZARA SILICONE BLOCK
K913882 · MIB
Byron Medical
General & Plastic Surgery · 236d
Cleared Apr 21, 1992
LIFE-AIR 1000 HYPOTHERMIC TREATMENT SYSTEM
K914382 · DWJ
Progressive Dynamics, Inc.
Cardiovascular · 203d
Cleared Apr 21, 1992
BLOOM TRANSPARENT STENCIL
K914759 · FZZ
Freckles Publications, Inc.
General & Plastic Surgery · 182d
Cleared Apr 21, 1992
ARGEBOND 77+
K915165 · EJS
Argen Precious Metals, Inc.
Dental · 158d
Cleared Apr 21, 1992
DEROYAL HYDROGEL DRESSING
K915182 · NAE
Deroyal Industries, Inc.
General & Plastic Surgery · 158d
Cleared Apr 21, 1992
WIL-PDS & WIL-PDI CASTING ALLOYS
K915250 · EJH
Wilde-USA, Inc.
Dental · 158d
Cleared Apr 21, 1992
BISCO CAVITY CLEANSER
K915668 · EBF
Bisco, Inc.
Dental · 125d
Cleared Apr 21, 1992
WEINSTEIN CORNEAL MIRCOAESTHESIOMETER
K920271 · HJC
Connecticut Bioinstruments, Inc.
Ophthalmic · 90d
Cleared Apr 21, 1992
DEPUY TOTAL HIP BALLS - ION IMPLANTATION
K920286 · JDI
Depuy, Inc.
Orthopedic · 90d
Cleared Apr 21, 1992
DAVIS AND GECK HANDHELD INST. STERILIZATION TRAY
K920293 · FLE
Davis & Geck, Inc.
General Hospital · 90d
Cleared Apr 21, 1992
SUNGLASSES
K920344 · HQY
J & D Products, Inc.
Ophthalmic · 89d
Cleared Apr 21, 1992
DW 215-12A ALLOY FOR FORCELAIN FUSED TO METAL
K920613 · EJS
Ivoclar North America, Inc.
Dental · 70d
Cleared Apr 21, 1992
CLEARSITE HYDROGEL WOUND DRESSING MODIFICATION
K920677 · NAE
New Dimensions IN Medicine, Inc.
General & Plastic Surgery · 67d
Cleared Apr 21, 1992
SEPTOCALCINE ULTRA
K920692 · EJK
Specialites Septodont
Dental · 67d
Cleared Apr 21, 1992
HOLLOW SCREW IMPLANTS 6MM, 14MM, 16MM
K920768 · DZE
The Straumann Co.
Dental · 70d
Cleared Apr 21, 1992
FLASH BOND
K920781 · DYH
Advanced Orthodontics Systems, Inc.
Dental · 61d
Cleared Apr 21, 1992
PERCUGUIDE LESION MARKING
K920816 · GDF
E-Z-Em, Inc.
General & Plastic Surgery · 75d
Cleared Apr 21, 1992
IMPROVED SEQUENCE LIGHT CURE ADHESIVE
K921385 · DYH
Ormco Corp.
Dental · 29d