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
98185–98208 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 11, 1996
DISPOSABLE NEUROVIEW INTRODUCER SHEATH
K960792 · GWG
Neuro Navigational Corp.
Neurology · 44d
Cleared Apr 10, 1996
MRI'S ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE
K944673 · EZL
Regulatory & Marketing Services, Inc.
Gastroenterology & Urology · 566d
Cleared Apr 10, 1996
HAEMOPHILUS TEST MEDIUM (HTM)
K952595 · JSO
Clinical Standards Laboratories, Inc.
Microbiology · 309d
Cleared Apr 10, 1996
EIA KIT FOR THE DETECTION OF GBM ANTIBODIES
K953495 · DBL
Scimedx Corp.
Immunology · 259d
Cleared Apr 10, 1996
POWERCHAIR
K954135 · ITI
Wheelcare Scooters, Inc.
Physical Medicine · 222d
Cleared Apr 10, 1996
EOS BRAND DISPOSABLE PROCTOSCOPE
K954614 · GCP
North Eos Industries, Inc.
Gastroenterology & Urology · 188d
Cleared Apr 10, 1996
FORCEGUARD
K955034 · IRN
Impact Monitors, Inc.
Physical Medicine · 160d
Cleared Apr 10, 1996
OMEGA+ COMPRESSION SCREW SYSTEM
K955306 · KTT
Howmedica Corp.
Orthopedic · 142d
Cleared Apr 10, 1996
SPORTS CONTRAST THERAPY SYSTEM ST 7000
K955326 · ILO
Burke Neutech, Inc.
Physical Medicine · 142d
Cleared Apr 10, 1996
BIO-INTERFACES, INC., BIORESORBABLE CALCIUM PHOSPHATE PARTICLES - BII-GRAFT 6140
K960164 · LYC
Bio-Interfaces, Inc.
Dental · 85d
Cleared Apr 10, 1996
RESOUND PERSONAL HEARING SYSTEMS EDR ENCORE SERIES MODELS EDR-E, EDR-ES,...
K960680 · ESD
Resound Corp.
Ear, Nose, Throat · 50d
Cleared Apr 10, 1996
HEARING AID - AIR CONDUCTION
K960684 · ESD
Resound Corp.
Ear, Nose, Throat · 50d
Cleared Apr 10, 1996
ARTHOSCOPE
K960805 · HRX
United States Surgical, A Division of...
Orthopedic · 42d
Cleared Apr 10, 1996
SUNGLASSES OR MULTIPLE
K960890 · HQY
Outdoor Action Wear Specialties
Ophthalmic · 36d
Cleared Apr 10, 1996
POWER PLUS (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS
K960926 · LPL
Unilens Corp., USA
Ophthalmic · 35d
Cleared Apr 10, 1996
FRANCO SORDELLI SUNGLASSES
K960950 · HQY
Franco Sordelli & C. Snc
Ophthalmic · 30d
Cleared Apr 10, 1996
LACTOSORB TRAUMA PLATING SYSTEM
K960988 · HRS
Poly-Medics,Inc.
Orthopedic · 34d
Cleared Apr 10, 1996
US-HOLO SUNGLASSES
K961035 · HQY
Mi Technologies, Inc.
Ophthalmic · 27d
Cleared Apr 09, 1996
PEACOCK PLAN
K940663 · IYE
Nomos Corp.
Radiology · 781d
Cleared Apr 09, 1996
SMALL BOWEL ANALYSIS SOFTWARE
K942247 · FFX
Sandhill Scientific, Inc.
Gastroenterology & Urology · 701d
Cleared Apr 09, 1996
ACCESS RUBELLA IGG
K954687 · LFX
Bio-Rad Laboratories, Inc.
Microbiology · 181d
Cleared Apr 09, 1996
PENEVAC ABC HANDPIECE
K955020 · GEI
I.C Medical, Inc.
General & Plastic Surgery · 159d
Cleared Apr 09, 1996
0.014 INTERMEDIATE GUIDE WIRE W/PHOSPHORYLCHOLINE POLYMER COATING
K955135 · DQX
Biocompatibles , Ltd.
Cardiovascular · 152d
Cleared Apr 09, 1996
OSTEONICS N2/VAC PACKAGING PROCESS
K955944 · KWS
Osteonics Corp.
Orthopedic · 133d