Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
162601–162624 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 02, 1981
ANERIOD GAUZE
K812932 · DXG
Abco Dealers, Inc.
Cardiovascular · 43d
Cleared Dec 02, 1981
RMI TRANSILLUMINATOR, MODEL 292
K812949 · HJM
Radiation Measurements, Inc.
Radiology · 42d
Cleared Dec 02, 1981
RESPOND II...NEUROMUSCULAR STIMULATOR
K813008 · IPF
Medtronic Vascular
Physical Medicine · 36d
Cleared Dec 02, 1981
HELIOSEAL
K813015 · EBC
Vivadent (Usa), Inc.
Dental · 36d
Cleared Dec 02, 1981
FUKUDA DENSHI CARDIMAX FK-12
K813022 · DPS
Brentwood Instruments, Inc.
Cardiovascular · 36d
Cleared Dec 02, 1981
FUKUDA DENSHI CARDIMAX FK-11
K813023 · DSP
Brentwood Instruments, Inc.
Cardiovascular · 36d
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