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
151537–151560 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 17, 1984
HYCEL ROTOR-MIXER AND/OR MULTI
K842746 · KSQ
R&D Systems, Inc.
Hematology · 35d
Cleared Aug 17, 1984
OSMOTIC PRESSURE AUTO & STAT OM-6010
K842750 · JJM
Kyoto Diagnostics, Inc.
Chemistry · 35d
Cleared Aug 17, 1984
OMNI-TRACT SURGICAL RETRACTOR SYS
K842762 · GAD
Minnesota Scientific, Inc.
General & Plastic Surgery · 32d
Cleared Aug 17, 1984
SILIMED BREAST FORM
K842765 · GBI
Sil-Med Corp.
General & Plastic Surgery · 32d
Cleared Aug 17, 1984
MIN. ESSENTIAL MED. W/L-GLUTAMINE, RIB
K842775 · KIT
Sigma Chemical Co.
Microbiology · 32d
Cleared Aug 17, 1984
PHYSIOLOGICAL ANALYZER CM-710
K842782 · BZM
Cybermedic, Inc.
Anesthesiology · 31d
Cleared Aug 17, 1984
TECHNICON RA-1000 SYS, DIRECT BILIRUBIN
K842809 · CIG
Technicon Instruments Corp.
Chemistry · 30d
Cleared Aug 17, 1984
DENTI-D RUBBER DAM
K842844 · EIE
Fema Corp.
Dental · 28d
Cleared Aug 17, 1984
SEWON DENTAL FLOSS FOLDER
K842846 · JES
Sewon Industry
Dental · 28d
Cleared Aug 17, 1984
TRIPLE SUGAR IRON
K842850 · JSH
Anarobe Systems
Microbiology · 28d
Cleared Aug 17, 1984
MUELLER HINTON BROTH
K842854 · JTZ
Anarobe Systems
Microbiology · 28d
Cleared Aug 17, 1984
RADOVAN TISSUE EXPANDER
K842883 · LCJ
Mentor Corp.
General & Plastic Surgery · 25d
Cleared Aug 17, 1984
BLOM-SINGER LOW PRESSURE VOICE PROSTHES
K842896 · EWL
American V. Mueller
Ear, Nose, Throat · 25d
Cleared Aug 17, 1984
CURITY I.V. START KIT
K842898 · LRS
The Kendal Co.
General & Plastic Surgery · 25d
Cleared Aug 17, 1984
BOUNDARY SINGLE-USE OR GOWN
K842958 · FYA
Procter & Gamble Mfg. Co.
General Hospital · 21d
Cleared Aug 17, 1984
RHYS-DAVIES EXSANGUINATOR
K842963 · KCY
Woodville Polymer Engineering, Ltd.
General & Plastic Surgery · 21d
Cleared Aug 17, 1984
BROWNIE BOOTH BB1
K842975 · FTC
Weingart, Inc.
General & Plastic Surgery · 18d
Cleared Aug 17, 1984
GRASSHOPPER - RETRACTOR
K842992 · GAD
Norton Texas Medical Products
General & Plastic Surgery · 18d
Cleared Aug 17, 1984
VINYL EXAM GLOVES, NON-STERILE
K843016
Abco Dealers, Inc.
General & Plastic Surgery · 17d
Cleared Aug 17, 1984
DISPOS. & SPONGE FORCEPS PEAN ARTERY
K843074 · GEN
Greene International Corp.
General & Plastic Surgery · 11d
Cleared Aug 17, 1984
AVA-NEB NEBULIZER
K843102 · CCQ
Avatron, Inc.
Anesthesiology · 10d
Cleared Aug 17, 1984
DISPOSABLE SKIN MARKING PEN
K843116 · FZZ
E.M. Adams
General & Plastic Surgery · 9d
Cleared Aug 17, 1984
ETI TENS BELT
K843119 · GZJ
Electro Therapeutic Devices, Inc.
Neurology · 9d
Cleared Aug 17, 1984
MICRO-TEMP PUMPS & MICRO-TEMP PADS
K843146 · ILO
Seabrook Medical Systems, Inc.
Physical Medicine · 7d