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
157825–157848 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 28, 1983
ULTRASOUND EQUIPMENT MODEL SDL-100A
K837084
Elscint, Inc.
Radiology · 93d
Cleared Apr 28, 1983
TRANSPARENT X-RAY COMPENSATION FILTER
K837245
Victoreen, Inc.
Radiology · 51d
Cleared Apr 27, 1983
PERSONAL ROMEAR
K823588 · ESD
Romear Mfg., Inc.
Ear, Nose, Throat · 142d
Cleared Apr 27, 1983
EK COMBI MSG-1
K830410 · DSP
Jedmed Instrument Co.
Cardiovascular · 78d
Cleared Apr 27, 1983
MINISCOPE MS-2
K830411 · DSP
Jedmed Instrument Co.
Cardiovascular · 78d
Cleared Apr 27, 1983
PHADEBACT STREP F TEST
K830445 · GTZ
Pharmacia, Inc.
Microbiology · 76d
Cleared Apr 27, 1983
QBC CENTRIFUGAL HEMATOLOGY SYS
K830451 · GKL
Bd Becton Dickinson Vacutainer...
Hematology · 71d
Cleared Apr 27, 1983
ELECTROSURGICAL CAULTERY PENCIL
K830532 · GEI
American V. Mueller
General & Plastic Surgery · 68d
Cleared Apr 27, 1983
POTASSIUM ANALYZER-SODIUM/ELECTROLYTE
K830588 · JGS
Shaban Mfg. Co.
Chemistry · 63d
Cleared Apr 27, 1983
ELECTROLYTE STANDARD - CORNING NALK ISE
K830589 · JGS
Shaban Mfg. Co.
Chemistry · 63d
Cleared Apr 27, 1983
ULTRAFILTRATION MONITOR UFM-10-2
K830596 · KDI
Gambro, Inc.
Gastroenterology & Urology · 62d
Cleared Apr 27, 1983
GENT-L-SPEC DISPOS. VAGINAL SPECULUM
K830725 · HIB
Geneva Laboratories, Inc.
Obstetrics & Gynecology · 50d
Cleared Apr 27, 1983
NEW ALLERGEN DISCS FOR USE IN VAST VENT
K830817 · DGC
Ventrex Laboratories, Inc.
Immunology · 43d
Cleared Apr 27, 1983
MICRO-MITT
K830821 · FXP
CooperVision, Inc.
General Hospital · 43d
Cleared Apr 27, 1983
COOL-LITE FIBERCOPTIC LARYNGEAL EXAM
K830888 · EQN
National Medical Technology
Ear, Nose, Throat · 37d
Cleared Apr 27, 1983
SURGICAL FACE MASK
K830890 · FXX
Busse Hospital Disposables, Inc.
General Hospital · 37d
Cleared Apr 27, 1983
ACTH RIA SYSTEM-DSI 2300
K830893 · CKG
Diagnostic Systems Laboratories, Inc.
Chemistry · 37d
Cleared Apr 27, 1983
I.E.C COLUMN
K830918 · KEA
Berwick Medical Products, Inc.
Chemistry · 36d
Cleared Apr 27, 1983
NETILMICIN 30MCG. SENSITIVITY DISCS
K830956 · JTN
Difco Laboratories, Inc.
Immunology · 33d
Cleared Apr 27, 1983
I.V. CATHETER PLACEMENT UNIT POLYURETH
K830972 · FOZ
Critikon Company, LLC
General Hospital · 30d
Cleared Apr 27, 1983
GIREX
K831033 · ION
Lancer Assoc.
Physical Medicine · 27d
Cleared Apr 27, 1983
ENA TEST KIT SM & RNP AUTO ANTIBODY
K831036 · LLL
Calbiochem-Behring Corp.
Immunology · 27d
Cleared Apr 27, 1983
PHADEBAS & PHADEZYM RAST MIXED ALLERG
K831045 · DHB
Pharmacia, Inc.
Immunology · 27d
Cleared Apr 27, 1983
ANTINUCLEAR ANTIBODY TISSUE CULTURE SUB
K831054 · DHN
Immuno-Products Industries
Immunology · 26d