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
171913–171936 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 28, 1978
SOF-WICKLAP PAD
K780718 · GDY
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery · 58d
Cleared Jun 28, 1978
IDI GDR DATA REDUCTION SYSTEM
K780813
Iso-Data, Inc.
Radiology · 44d
Cleared Jun 28, 1978
DILUTER/DISPENSER
K780882 · JQW
Innovative Medical Systems, Inc.
Chemistry · 29d
Cleared Jun 28, 1978
THERMO SET ELECTRONIC TEM. CONTROLLER
K780888 · JRI
Gilford Instrument Laboratories, Inc.
Chemistry · 33d
Cleared Jun 28, 1978
AUTOMATED ELECTROPHORESIS SYSTEM
K780901 · JQT
Olympus Corp.
Chemistry · 27d
Cleared Jun 28, 1978
FISHER SPECTROPHOTOMETER
K780902 · JJQ
Bausch & Lomb, Inc.
Chemistry · 28d
Cleared Jun 28, 1978
CLINICAL ANALYZER SYSTEM
K780903 · JJQ
Bausch & Lomb, Inc.
Chemistry · 28d
Cleared Jun 28, 1978
SYSMEX AUTO. BLOOD CELL COUNTER, CC-120
K780909 · GKL
Toa Medical Electronics USA, Inc.
Hematology · 27d
Cleared Jun 28, 1978
SYSTEM AUTO. BLOOD CELL COUNTER CC-110
K780910 · GKL
Toa Medical Electronics USA, Inc.
Hematology · 27d
Cleared Jun 28, 1978
SYSMEX PLATELET COUNTER, PL-110
K780911 · GKL
Toa Medical Electronics USA, Inc.
Hematology · 27d
Cleared Jun 28, 1978
ADJUSTABLE DISPENSOR
K780912 · JQW
Oxford Laboratories, Inc.
Chemistry · 23d
Cleared Jun 28, 1978
SOFT LENS INSERTER
K780931 · KYE
Soft-Sert
Ophthalmic · 22d
Cleared Jun 28, 1978
ELECTROENCEPHALOGRAPH ACCUTRATE 200
K781005 · GWQ
Beckman Instruments, Inc.
Neurology · 9d
Cleared Jun 28, 1978
ISOTONIC DILUENT
K781008 · GIF
Mallinckrodt Critical Care
Hematology · 9d
Cleared Jun 28, 1978
OTOSCOPE, DIAG. MODELS 20100 & 20200
K781029 · ERA
Welch Allyn, Inc.
Ear, Nose, Throat · 9d
Cleared Jun 28, 1978
HEARING AID
K781033 · ESD
Phonemics, Inc.
Ear, Nose, Throat · 9d
Cleared Jun 28, 1978
ELECTROENCEPHALOGRAPH ACCUTRACE 100
K781041 · GWQ
Beckman Instruments, Inc.
Neurology · 8d
Cleared Jun 27, 1978
ULTRASONIC IMAGER
K780876 · HEM
Air-Shields, Inc.
Radiology · 28d
Cleared Jun 27, 1978
X-RAY SYSTEM
K780963 · KPQ
General X-Ray, Inc.
Radiology · 15d
Cleared Jun 27, 1978
GAMMA CAMERA
K780969 · IYX
Machlett Laboratories, Inc.
Radiology · 15d
Cleared Jun 27, 1978
X-RAY FRAME HOLDER
K780999 · IZL
Great Eastern Lumber Co., Inc.
Radiology · 18d
Cleared Jun 22, 1978
URIC ACID REFERENCE SERA
K780447 · JIT
Macomb Chemical Co.
Chemistry · 94d
Cleared Jun 22, 1978
STIMULATOR MODEL 8021
K780539 · GWF
Life-Tech Instruments, Inc.
Neurology · 80d
Cleared Jun 22, 1978
DETECTOR, BUBBLE & FOAM
K780582 · FJF
Hospal Medical Corp.
Gastroenterology & Urology · 71d