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
165817–165840 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 16, 1980
PUIG MASSANA-SHILEY ANNULOPLASTY RING
K801879 · KRH
Shiley, Inc.
Cardiovascular · 132d
Cleared Dec 16, 1980
HP MODEL 77020A ULTRASOUND SYSTEM
K801954 · IYO
Hewlett-Packard Co.
Radiology · 120d
Cleared Dec 16, 1980
SONIC EAR
K802382 · ESD
Acousticon Electronics
Ear, Nose, Throat · 76d
Cleared Dec 16, 1980
MS 16 SYRINGE DRIVER
K802400 · FRN
Princeton Medical Instruments, Inc.
General Hospital · 75d
Cleared Dec 16, 1980
BLOOD PRESSURE UNIT MODEL 310
K802411 · DXN
Js & A Group
Cardiovascular · 74d
Cleared Dec 16, 1980
BLOOD PRESSURE UNIT MODEL 410
K802412 · DXN
Js & A Group
Cardiovascular · 74d
Cleared Dec 16, 1980
SYNTHES SPINAL IMPLANT SYSTEM
K802462 · KWP
Synthes (Usa)
Orthopedic · 69d
Cleared Dec 16, 1980
DPA 207 PERSONAL
K802513 · KCX
Hill, Farrer & Borrill
General & Plastic Surgery · 62d
Cleared Dec 16, 1980
CYE BIPHASIC BLOOD CULTURE MEDIUM
K802571 · JSJ
Remel Co.
Microbiology · 60d
Cleared Dec 16, 1980
ORTRON 90* HIP PROSTHESIS
K802627 · JDI
Cintor Orthopaedic Div.
Orthopedic · 54d
Cleared Dec 16, 1980
POLYCARBONATE TEMPORARY CEMENT
K802662 · EMA
Buffalo Dental Mfg. Co., Inc.
Dental · 49d
Cleared Dec 16, 1980
ARGYLE CLOSED URINARY DRAINAGE SET
K802667 · KNX
Sherwood Medical Co.
Gastroenterology & Urology · 49d
Cleared Dec 16, 1980
SPIRAFLO BLOOD OXYGENATORS MODEL BOS-10S
K802719 · DTZ
Bentley Laboratories, Inc.
Cardiovascular · 46d
Cleared Dec 16, 1980
SPIRAFLO BLOOD OXYGENATORS MODEL BOS-5S
K802720 · DTZ
Bentley Laboratories, Inc.
Cardiovascular · 46d
Cleared Dec 16, 1980
FIBER OPTIC ADAPTER CAT#60-0898
K802766 · EQH
Aspen Laboratories, Inc.
Ear, Nose, Throat · 43d
Cleared Dec 16, 1980
FIBER OPTIC LIGHT GUIDE CAT#60-0768
K802767 · EQH
Aspen Laboratories, Inc.
Ear, Nose, Throat · 43d
Cleared Dec 16, 1980
FIBER OPTIC ADAPTER #60-0897
K802768 · EQH
Aspen Laboratories, Inc.
Ear, Nose, Throat · 43d
Cleared Dec 16, 1980
FIBER OPTIC ADAPTER #60-895
K802771 · EQH
Aspen Laboratories, Inc.
Ear, Nose, Throat · 43d
Cleared Dec 16, 1980
FIBER OPTIC ADAPTER #60-0894
K802772 · EQH
Aspen Laboratories, Inc.
Ear, Nose, Throat · 43d
Cleared Dec 16, 1980
FIBER OPTIC LIGHT GUIDE #60-0767
K802773 · EQH
Aspen Laboratories, Inc.
Ear, Nose, Throat · 43d
Cleared Dec 16, 1980
FIBER OPTIC ADAPTER #60-0892
K802774 · EQH
Aspen Laboratories, Inc.
Ear, Nose, Throat · 43d
Cleared Dec 16, 1980
FIBER OPTIC ADAPTER #60-0896
K802775 · EQH
Aspen Laboratories, Inc.
Ear, Nose, Throat · 43d
Cleared Dec 16, 1980
SURGEONS CHOICE STAPLE, REMOVE/IMPLANT
K802783 · GBN
Hospital Products Intl.
General & Plastic Surgery · 42d
Cleared Dec 16, 1980
OXYGEN SATURATION METER MODEL NO. SM-1
K802847
Bentley Laboratories, Inc.
Cardiovascular · 34d