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
129385–129408 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 10, 1989
BIOTRACK HEMOGLOBIN TEST CARTRIDGE
K895101 · KHG
Biotrack, Inc.
Hematology · 56d
Cleared Oct 10, 1989
BIOTRACK PDS MONITOR
K895102 · JJQ
Biotrack, Inc.
Hematology · 56d
Cleared Oct 10, 1989
ARGOS
K895127 · GKZ
Abx, Inc.
Hematology · 54d
Cleared Oct 10, 1989
RUBBER LATEX SURGICAL GLOVES, STERILE
K895448 · KGO
Dah Lee Rubber Industries (Thai) , Ltd.
General Hospital · 32d
Cleared Oct 10, 1989
SHAMROCK SAFETY WINGED INFUSION SET
K895481 · FPA
Ryan Medical, Inc.
General Hospital · 29d
Cleared Oct 10, 1989
SHAMROCK SAFETY BLOOD COLLECTION SET
K895705 · FMI
Ryan Medical, Inc.
General Hospital · 29d
Cleared Oct 06, 1989
INTERMEDICS HIGH TIBIAL OSTEOTOMY SYSTEM
K892228 · HRS
Intermedics Orthopedics
Orthopedic · 184d
Cleared Oct 06, 1989
RESUBMITTED RD1000 NEOPUFF INFANT RESUSCITATOR
K892885 · BTL
Fisher & Paykel Electronics , Ltd.
Anesthesiology · 170d
Cleared Oct 06, 1989
MITEK ANCHOR DRILL
K892903 · HTW
Mitek Surgical Products, Inc.
Orthopedic · 169d
Cleared Oct 06, 1989
FIRST CHOICE (TM)
K893205 · CGA
Polymer Technology Corp.
Chemistry · 163d
Cleared Oct 06, 1989
SPECTRASTIM TM 1000
K893964 · IPF
Therapeutic Technologies, Inc.
Physical Medicine · 126d
Cleared Oct 06, 1989
DEVILBISS MODEL 8500D AND 8500D-608
K894244 · CCQ
Devilbiss Health Care, Inc.
Anesthesiology · 107d
Cleared Oct 06, 1989
PERIODONTAL IRRIGATING SOLUTION-D
K894247 · ELC
Dentsply Intl.
Dental · 107d
Cleared Oct 06, 1989
OHMEDA MODULUS CD ANESTHESIA SYSTEM
K894309 · BSZ
Ohmeda Medical
Anesthesiology · 84d
Cleared Oct 06, 1989
SECOND GENERATION KNEE SYSTEM
K894334 · JWH
Orthomet, Inc.
Orthopedic · 84d
Cleared Oct 06, 1989
SINGLE PATIENT USE DISPOSABLE MANUAL RESUSCITATOR
K894365 · BTM
Puritan Bennett Corp.
Anesthesiology · 84d
Cleared Oct 06, 1989
AUTOMIX 3+3 COMPOUNDER
K894827 · LHI
Baxter Healthcare Corp
General Hospital · 67d
Cleared Oct 06, 1989
MARK IV HAND, THUMB AND WRIST (CPM) UNIT
K894907 · BXB
Innovative Medical Engineering, Inc.
Physical Medicine · 66d
Cleared Oct 06, 1989
HIGH PRESSURE INERT PLASTIC COLUMNS FOR CLIN. USE
K895105 · DPM
Waters Chemical Products
Chemistry · 52d
Cleared Oct 06, 1989
BIOTRACK ALT TEST CARTRIDGE
K895128 · CJJ
Biotrack, Inc.
Chemistry · 50d
Cleared Oct 06, 1989
ORTHO *APO A-1 ELISA TEST SYSTEM
K895160 · DEL
Medical Marketing Consultants, Inc.
Immunology · 44d
Cleared Oct 06, 1989
TECHNOMED PULSOLITH LASER SYSTEM
K895178 · FFK
Teknomed, Inc.
Gastroenterology & Urology · 57d
Cleared Oct 06, 1989
ABL500 BLOOD GAS SYSTEM
K895181 · CHL
Radiometer America, Inc.
Chemistry · 56d
Cleared Oct 06, 1989
APTT-P REAGENT, A PARTICLE ACTIVATED REAGENT
K895255 · GFO
Medical Diagnostic Technologies, Inc.
Hematology · 46d