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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
146209–146232 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 03, 1986
REHABILITATION TABLES
K854947 · INQ
I-Rep, Inc.
Physical Medicine · 24d
Cleared Jan 03, 1986
BBL PORT-A-CUL AEROBIC TRANSPORT SYS, MODIFIED STU
K854986 · JSM
Bd Becton Dickinson Vacutainer...
Microbiology · 22d
Cleared Jan 01, 1986
HYDRO-BAC FILTER
K852866 · CAI
Medicomp, Inc.
Anesthesiology · 177d
Cleared Jan 01, 1986
JECT-AID
K853031 · KZE
Autoject Systems, Inc.
General Hospital · 167d
Cleared Jan 01, 1986
TANDEM ICON RUBELLA IGG IMMUNOENZYMETRIC ASSAY KIT
K853069 · LFX
Hybritech, Inc.
Microbiology · 163d
Cleared Jan 01, 1986
ACE COMPUTER SYSTEM
K853482 · IYX
Cardiac Medical Systems Corp.
Radiology · 134d
Cleared Jan 01, 1986
KODAK M35 X-OMAT PROCESSOR
K854219 · IXW
Eastman Kodak Company
Radiology · 76d
Cleared Jan 01, 1986
QBC CENTRIFUGAL HEMATOLOGY SYSTEM
K854242 · GKZ
Bd Becton Dickinson Vacutainer...
Hematology · 72d
Cleared Jan 01, 1986
CELL-DYN 1500 MULTI-PARAMETER HEMATOLOGY ANALYZER
K854368 · GKZ
Abbott Diagnostics
Hematology · 64d
Cleared Jan 01, 1986
MINXRAY 500M MAMMOGRAPHIC SYSTEM
K854510 · IZH
Minxray, Inc.
Radiology · 50d
Cleared Dec 31, 1985
DIASONICS ADA400 ADVANCED DIGITAL ARRAY
K851972 · IYO
Diasonics, Inc.
Radiology · 238d
Cleared Dec 31, 1985
CERTI-FORM
K854001 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 92d
Cleared Dec 31, 1985
AUTOMATIC IMPEDANCE AUDIOMETER, TA-7B
K854043 · ETY
Teledyne Avionics Div. of Teledyne
Ear, Nose, Throat · 90d
Cleared Dec 31, 1985
CSM MEDIUM
K854052 · LYX
Northern Scientific, Inc.
Ophthalmic · 89d
Cleared Dec 31, 1985
SARATOGA SCT HEATED HUMIDIFICATION SYSTEM
K854363 · BTT
Saratoga Medical Instrumentation, Inc.
Anesthesiology · 63d
Cleared Dec 30, 1985
EKG 501 A
K840569 · DPS
Bosch Hearing Instruments, Inc.
Cardiovascular · 691d
Cleared Dec 30, 1985
EKG 503A
K840571 · DPS
Bosch Hearing Instruments, Inc.
Cardiovascular · 691d
Cleared Dec 30, 1985
PERI-GUARD PERICARDIAL PATCH
K842066 · DXZ
Genetic Laboratories, Inc.
Cardiovascular · 616d
Cleared Dec 30, 1985
VIRATEK SMALL PARTICLE AEROSOL GENERAT
K843717
Viratek, Inc.
Cardiovascular · 465d
Cleared Dec 30, 1985
HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8165
K852457 · DXN
Healthteam
Cardiovascular · 203d
Cleared Dec 30, 1985
HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8145
K852458 · DXN
Healthteam
Cardiovascular · 203d
Cleared Dec 30, 1985
HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8175
K852459 · DXN
Healthteam
Cardiovascular · 203d
Cleared Dec 30, 1985
HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8115
K852653 · DXN
Healthteam
Cardiovascular · 203d
Cleared Dec 30, 1985
QAD-1 ANGIO DYNOGRAPH ULTRASO W/5.0 7.5 MHZ PROBES
K853217 · IYO
Quantum Medical Systems, Inc.
Radiology · 151d