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
161761–161784 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 02, 1981
AQUANOMICS, #SP36SF
K813045 · KMG
Cooper-Hewitt Electric Co.
General Hospital · 35d
Cleared Dec 02, 1981
AQUANOMICS, #HHU60
K813046 · KMG
Cooper-Hewitt Electric Co.
General Hospital · 35d
Cleared Dec 02, 1981
AQUANOMICS, MINI 60L
K813047 · KMG
Cooper-Hewitt Electric Co.
General Hospital · 35d
Cleared Dec 02, 1981
AQUANOMICS, #MP2SF
K813048 · KMG
Cooper-Hewitt Electric Co.
General Hospital · 35d
Cleared Dec 02, 1981
AQUANOMICS, #HHU100
K813049 · KMG
Cooper-Hewitt Electric Co.
General Hospital · 35d
Cleared Dec 02, 1981
AQUANOMICS, #MP4SF
K813050 · KMG
Cooper-Hewitt Electric Co.
General Hospital · 35d
Cleared Dec 02, 1981
VIBRO-COM COMMUNICATOR #8827
K813057 · LRA
Sonic Systems, Inc.
Ear, Nose, Throat · 34d
Cleared Dec 02, 1981
CORREC TORR TM
K813137 · DRS
Norton Performance Plastics Corp.
Cardiovascular · 27d
Cleared Dec 02, 1981
DIRECTIONAL BOOT
K813150 · DXY
Pacesetter Systems
Cardiovascular · 26d
Cleared Dec 02, 1981
VITATRON INSERT
K813151 · DTD
Pacesetter Systems
Cardiovascular · 26d
Cleared Dec 02, 1981
ELECTRODE TERMINAL CAP
K813152 · DTD
Pacesetter Systems
Cardiovascular · 26d
Cleared Dec 02, 1981
TEST MAGNET
K813153 · DTG
Pacesetter Systems
Cardiovascular · 26d
Cleared Dec 02, 1981
ADAPTING SLEEVE
K813154 · DTD
Pacesetter Systems
Cardiovascular · 26d
Cleared Dec 02, 1981
AUTO-SYRINGE SUB-CUTEANEOUS SET
K813194 · FPA
Baxter Healthcare Corp
General Hospital · 15d
Cleared Dec 02, 1981
GEL FLOTATION MATTRESS
K813226 · IKY
Jefferson Industries, Inc.
General Hospital · 22d
Cleared Dec 02, 1981
QUANTIMETRIC 2 TEST KIT
K813242 · KEW
Kallestad Laboratories, Inc.
Immunology · 15d
Cleared Dec 01, 1981
STERILE SUTURE REMOVAL KIT
K812132 · MCZ
E.M. Adams
General & Plastic Surgery · 126d
Cleared Dec 01, 1981
ELITE
K812538 · IPF
Biotone International, Inc.
Physical Medicine · 89d
Cleared Nov 30, 1981
HEMASITE VASCULAR ACCESS SHUNT HM-1000
K813237 · FIQ
Renal Systems, Inc.
Gastroenterology & Urology · 20d
Cleared Nov 27, 1981
ELECTRODE, PACEMAKER, PERMANENT
K810139 · DTB
Pacesetter Systems
Cardiovascular · 310d
Cleared Nov 27, 1981
PACEPATH IMPLANT. ENDOCARD. PACING LEAD
K810286 · DTB
Pacesetter Systems
Cardiovascular · 298d
Cleared Nov 27, 1981
SNIFF AIR COMPRESSOR #SF-6
K812767 · BTI
Timeter Instrument Corp.
Anesthesiology · 53d
Cleared Nov 27, 1981
EIA RUBELLA
K812787 · LFX
Gilford
Microbiology · 53d
Cleared Nov 27, 1981
PFT SCREENER (SYSTEM 1100)
K812792 · BTY
Medical Graphics Corp.
Anesthesiology · 52d