FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
77425–77448 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 28, 2001
DEVICE MODIFICATION OF SILHOUETTE SPINDAL FIXATION SYSTEM
K012173 · KWP
Sulzer Spine-Tech
Orthopedic · 78d
Cleared Sep 28, 2001
STRYKER CROSS-PINNED INTERFERENCE SCREW SYSTEM
K012270 · JDW
Stryker Endoscopy
Orthopedic · 71d
Cleared Sep 28, 2001
RAPIDIA
K012290 · LLZ
3D Med Co., Ltd.
Radiology · 70d
Cleared Sep 28, 2001
SYSMEX UF-50
K012372 · LKM
Sysmex Corp.
Pathology · 64d
Cleared Sep 28, 2001
MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR
K012428 · MKJ
Medtronic Physio-Control Corp.
Cardiovascular · 59d
Cleared Sep 28, 2001
MODIFICATION TO N PROTEIN STANDARD SL
K012470 · JIX
Dade Behring, Inc.
Chemistry · 57d
Cleared Sep 28, 2001
PLATELETWORKS
K012723 · JOZ
Helena Laboratories
Hematology · 44d
Cleared Sep 28, 2001
DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM
K012795 · MST
Diamedix Corp.
Immunology · 38d
Cleared Sep 28, 2001
DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM
K012797 · MST
Diamedix Corp.
Immunology · 38d
Cleared Sep 28, 2001
LIQUISPX LIQUID SALIVA OR UNRINE DRUG OF ABUSE CONTROL
K012907 · DIF
Clinical Controls
Chemistry · 30d
Cleared Sep 28, 2001
3I LOCATER ABUTMENT SYSTEM
K012911 · DZE
Implant Innovations, Inc.
Dental · 29d
Cleared Sep 28, 2001
BARD UTAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER
K012913 · DQY
C.R. Bard, Inc.
Cardiovascular · 29d
Cleared Sep 28, 2001
MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000
K012926 · MTD
Endocardial Solutions, Inc.
Cardiovascular · 28d
Cleared Sep 28, 2001
CELL-DYN 3200 SYSTEM WITH ABSOLUTE AND PERCENT RETICULOCYTE
K012934 · GKZ
Abbott Laboratories
Hematology · 28d
Cleared Sep 28, 2001
AEROVENT II CHC COLLAPSIBLE HOLDING CHAMBER
K012939 · CAF
Monaghan Medical Corp.
Anesthesiology · 28d
Cleared Sep 28, 2001
REAADS ANTI-BETA 2 GLYCOPROTEIN I IGM TEST KIT
K013077 · MSV
Corgenix, Inc.
Immunology · 14d
Cleared Sep 28, 2001
REAADS ANTI-BETA 2 GLYCOPROTEIN I IGA TEST KIT
K013079 · MSV
Corgenix, Inc.
Immunology · 14d
Cleared Sep 28, 2001
REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT
K013080 · MSV
Corgenix, Inc.
Immunology · 14d
Cleared Sep 28, 2001
ADC COMPACT PLUS
K013138 · MQB
Agfa-Gevaert AG
Radiology · 9d
Cleared Sep 28, 2001
TE ME NA POLYSTIM NERVE STIMILATOR
K990323 · BXN
Te ME NA S.A.R.L.
Anesthesiology · 969d
Cleared Sep 27, 2001
SLENDERTONE FLEX, MODEL, 512
K010335 · NGX
Bio-Medical Research, Ltd.
Physical Medicine · 237d
Cleared Sep 27, 2001
DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR WITH OR WITHOUT SOFT VENOUS...
K010478 · DTZ
Dideco
Cardiovascular · 219d
Cleared Sep 27, 2001
DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES
K010712 · FID
Molded Products, Inc.
Gastroenterology & Urology · 202d
Cleared Sep 27, 2001
VITALLINK 1200 MOBILE VITAL SIGNS SYSTEMS (VL 1200 SYSTEM)
K010732 · MWI
Telemedic Systems, Inc.
Cardiovascular · 199d