FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
130585–130608 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 25, 1989
HYCOR SENTRY(TM) DRUGS OF ABUSE URINE CALIBRATORS
K893815 · DKB
Hycor Biomedical, Inc.
Toxicology · 63d
Cleared Jul 25, 1989
DAU I, DAU II, DAU III AND DAU IV CONTROL URINE
K893835 · DIF
Ciba Corning Diagnostics Corp.
Chemistry · 62d
Cleared Jul 25, 1989
HEMATOLOGY CONTROL MIXTURES FOR QUALITY CONTROL
K893895 · JPK
Intercare Diagnostics, Inc.
Hematology · 56d
Cleared Jul 25, 1989
P.S.A. FEMORAL HIP PROSTHESIS
K893959 · KWY
Protek, Inc.
Orthopedic · 54d
Cleared Jul 25, 1989
HDL PRECIPITATING REAGENT
K893966 · LBR
Diagnostic Systems
Chemistry · 53d
Cleared Jul 25, 1989
ACS HUMAN PLASMA COAGULATION CONTROL LEVEL II
K893970 · GGC
Analytical Control Systems, Inc.
Hematology · 53d
Cleared Jul 25, 1989
ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL II
K893971 · GGC
Analytical Control Systems, Inc.
Hematology · 53d
Cleared Jul 25, 1989
NEW WEST SUNGLASSES
K893986 · HQY
New West Promotions
Ophthalmic · 50d
Cleared Jul 25, 1989
MINICLINIC PREGNANCY TEST
K894012 · JHI
Vanguard Biomedical Corp.
Chemistry · 49d
Cleared Jul 25, 1989
MODIFIED POLYCHROME IV STAIN
K894045 · KFD
Devetec, Inc.
Pathology · 48d
Cleared Jul 25, 1989
RAOMER
K894112 · INI
Niagara Corp.
Physical Medicine · 43d
Cleared Jul 25, 1989
WORLD CHAIR
K894136 · IOR
Invacare Corp.
Physical Medicine · 42d
Cleared Jul 25, 1989
ANTI-THYROGLOBULIN TEST KIT
K894203 · JZO
Kronus
Immunology · 36d
Cleared Jul 25, 1989
TECNOL SILK STRIP
K894205 · FPX
Tecnol New Jersey Wound Care, Inc.
General & Plastic Surgery · 36d
Cleared Jul 25, 1989
MEDSCOPE 4MM ARTHROSCOPE
K894303 · HRX
Medscope Corp.
Orthopedic · 32d
Cleared Jul 25, 1989
ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL III
K894338 · GGC
Analytical Control Systems, Inc.
Hematology · 11d
Cleared Jul 25, 1989
MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO)
K894364 · JZO
Kronus
Immunology · 11d
Cleared Jul 24, 1989
NEOVO2R VENTILATORY
K885243 · BTM
Neomed
Anesthesiology · 214d
Cleared Jul 24, 1989
PVC EMPTY SOLUTION CONTAINER ENTERAL PUMP SET
K890093 · KNT
Kells Medical, Inc.
Gastroenterology & Urology · 195d
Cleared Jul 24, 1989
ANGIOGRAPHY CUSTOM PACKS
K891572 · DTL
Procedure Packs, Inc.
Cardiovascular · 126d
Cleared Jul 24, 1989
DISPOSABLE MEDICAL GOWNS
K891820 · FYB
Bioshield, Inc.
General Hospital · 126d
Cleared Jul 24, 1989
M1300A ULTRASOUND IMAGING SYSTEM, M1321A 3.5 MHZ
K892355 · IYO
Hewlett-Packard Co.
Radiology · 98d
Cleared Jul 24, 1989
MODIFIED OXYGEN DELIVERY/CO2 SAMPLE NASAL CANNULA
K892406 · CCK
Salter Labs
Anesthesiology · 108d
Cleared Jul 24, 1989
MODIFIED DEMAND NASAL OXYGEN CANNULA
K892407 · NFB
Salter Labs
Anesthesiology · 108d