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

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176,076 results
162409–162432 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 29, 1981
DIGITAL FLUROGRAPHIC IMAGING SYSTEM
K813217 · JAA
Diasonics, Inc.
Radiology · 50d
Cleared Dec 29, 1981
MODEL 4200 ELLESTAD STRESS TEST ANALYZER
K813222 · DXG
Del Mar Avionics
Cardiovascular · 50d
Cleared Dec 29, 1981
AFTERLOADING GYNECOLOGICAL APPLICATOR
K813230 · IWJ
Esi
Radiology · 49d
Cleared Dec 29, 1981
O'CONNOR HOOK PUNCH FORCEP
K813245 · GEN
Shutt Instruments
General & Plastic Surgery · 41d
Cleared Dec 29, 1981
TEMPERATURE PROBES
K813271 · KRI
Webster Laboratories, Inc.
Cardiovascular · 39d
Cleared Dec 29, 1981
VENOUS CANNULA TRAY
K813284 · DWS
Cunningham Woodland, Inc.
Cardiovascular · 36d
Cleared Dec 29, 1981
CONVERTORS STERILE DISP. LAP SPONGE II
K813296 · EFQ
American Convertors Div., American...
General & Plastic Surgery · 36d
Cleared Dec 29, 1981
DOUBLE SEAL TUBEGUAZE STERILE BANDAGE
K813308 · NAB
Scholl, Inc.
General & Plastic Surgery · 36d
Cleared Dec 29, 1981
THIGH CUFF: X-LARGE CUFF
K813323 · DXQ
Abco Dealers, Inc.
Cardiovascular · 35d
Cleared Dec 29, 1981
BODAI SWIVEL Y
K813324 · BSY
Sontek Industries, Inc.
Anesthesiology · 35d
Cleared Dec 29, 1981
P51 ANGIOPLASTY PRESSURE TRANSDUCER
K813331 · LIT
Konigsberg Instruments, Inc.
Cardiovascular · 35d
Cleared Dec 29, 1981
GERARD MEDICAL ELECTRODE TESTER
K813358 · KRC
Gerard Medical Enterprises, Inc.
Cardiovascular · 29d
Cleared Dec 29, 1981
METRONIDAZOLE 80MCG. SENSI-DISC
K813387 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 27d
Cleared Dec 29, 1981
TISSUE PROCESSING CASSETTES & ACCESS
K813430 · IDL
American Optical Corp.
Pathology · 21d
Cleared Dec 29, 1981
PNEUMO PULSSOR
K813438 · BYI
Strom Corp.
Anesthesiology · 21d
Cleared Dec 29, 1981
CEFINASE TM DISCS
K813442 · JTO
Bd Becton Dickinson Vacutainer...
Microbiology · 19d
Cleared Dec 29, 1981
NIHON KOHDEN HEART MONITORS OMP 7101-02
K813444 · DRT
Nihon Kohden America, Inc.
Cardiovascular · 20d
Cleared Dec 29, 1981
PERCUTANEOUS ENTRY NEEDLE, SELDINGER
K813461 · DRE
Ocean Medical Products, Ltd.
Cardiovascular · 18d
Cleared Dec 29, 1981
LINE POWERED LOW ENERGY DEFIBRILLATOR II
K813471 · LDD
Narco Scientific
Cardiovascular · 15d
Cleared Dec 29, 1981
LS 5800 SERIES LIQUID SCINTILLATION
K813472 · JJJ
Beckman Instruments, Inc.
Toxicology · 15d
Cleared Dec 29, 1981
OMED DISPOSABLE BULLDOG
K813499 · DXC
Omega-Med Intl., Inc.
Cardiovascular · 15d
Cleared Dec 29, 1981
TRANSCUTANEOUS ELEC. NERVE STIMULATOR
K813501 · GZJ
Empi
Neurology · 15d
Cleared Dec 29, 1981
NARCO TELECARE ISOFLO PRESSURE MONITOR
K813502 · DRS
Narco Bio-Systems
Cardiovascular · 14d
Cleared Dec 29, 1981
SAC-CEL
K813508 · KTS
Burroughs Wellcome Co.
Pathology · 14d