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
168961–168984 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 05, 1979
CONPHAR FACE MASK-STERILE
K792110 · FXX
Conphar, Inc.
General Hospital · 11d
Cleared Oct 30, 1979
OREIA-TU THYROID UPTAKER RATIO ASSAY
K791172
Organon, Inc.
Chemistry · 127d
Cleared Oct 30, 1979
VERI-VU LENSOMETER
K791521 · HLM
Intermedics, Inc.
Ophthalmic · 81d
Cleared Oct 30, 1979
WARM-EE HEAT PACK
K791684 · IME
U.S. Export Marketing Group, Inc.
Physical Medicine · 63d
Cleared Oct 30, 1979
MODEL H44-80 BEHIND THE EAR HEARING
K791745 · ESD
Marcon Hearing Instruments, Inc.
Ear, Nose, Throat · 50d
Cleared Oct 30, 1979
3M UPF PROXIMAL FEMUR REPLACEMENT SYSTEM
K791823 · KWY
3M Company
Orthopedic · 46d
Cleared Oct 30, 1979
VMA BY COLUMN TEST
K791837 · CDF
Bio-Rad
Chemistry · 46d
Cleared Oct 30, 1979
RIONET HEARING AID HB-32
K791876 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 60d
Cleared Oct 30, 1979
RIONET HEARING AID HB-32H
K791877 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 60d
Cleared Oct 30, 1979
RIONET HEARING AID HB-67T
K791882 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 60d
Cleared Oct 30, 1979
RIONET HEARING AID HI-60
K791884 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 60d
Cleared Oct 30, 1979
19091-XXXXX SER. OF GLASS CAPILLARY COL.
K791893 · DII
Hewlett-Packard Co.
Toxicology · 35d
Cleared Oct 30, 1979
OCUTOME MODEL 8000
K791898 · HKP
Cooper Medical Devices Corp.
Ophthalmic · 35d
Cleared Oct 30, 1979
COULTER DIFF3 SYS. (COULTER #7400003)
K791903 · GKZ
Coulter Electronics, Inc.
Hematology · 35d
Cleared Oct 30, 1979
X-PAK
K791917 · HMX
Contemporary Surgical Systems, Inc.
Ophthalmic · 35d
Cleared Oct 30, 1979
ATMOS ENT TREATMENT SYSTEM SERVANT 3
K791934 · ETF
Jedmed Instrument Co.
Ear, Nose, Throat · 33d
Cleared Oct 30, 1979
ATMOS ENT CABINET PRACTICA 3
K791935 · ETF
Jedmed Instrument Co.
Ear, Nose, Throat · 33d
Cleared Oct 30, 1979
ATMOS ENT CABINET PRACTICA 2
K791936 · ETF
Jedmed Instrument Co.
Ear, Nose, Throat · 33d
Cleared Oct 30, 1979
PHENOL RED AGAR
K791939 · JSH
Isle Media and Sterile Products, Inc.
Microbiology · 29d
Cleared Oct 30, 1979
UREA AGAR
K791940 · JSI
Isle Media and Sterile Products, Inc.
Microbiology · 29d
Cleared Oct 30, 1979
PHENOL RED BROTH
K791941 · JSH
Isle Media and Sterile Products, Inc.
Microbiology · 29d
Cleared Oct 30, 1979
BILE ESCULIN AZIDE AGAR
K791942 · JSI
Isle Media and Sterile Products, Inc.
Microbiology · 29d
Cleared Oct 30, 1979
NUTRIENT AGAR
K791943 · JSG
Isle Media and Sterile Products, Inc.
Microbiology · 29d
Cleared Oct 30, 1979
NITRATE AGAR
K791944 · JSH
Isle Media and Sterile Products, Inc.
Microbiology · 29d