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.

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

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175,820 results
45481–45504 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 06, 2012
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
K112523 · DHB
Siemens Healthcare Diagnostics, Inc.
Immunology · 128d
Cleared Jan 06, 2012
MIRAGE QUATTRO
K113127 · BZD
Resmed, Ltd.
Anesthesiology · 74d
Cleared Jan 06, 2012
GLUCOSE TEST SYSTEM
K113137 · NBW
Roche Diagnostics
Chemistry · 74d
Cleared Jan 06, 2012
U-RIGHT TD-1240 THERMOMETER
K113159 · FLL
Taidoc Technology Corporation
General Hospital · 72d
Cleared Jan 06, 2012
IVAS 20MM (10 GAUGE) BALLOON CATHETER
K113477 · NDN
Stryker Instruments, Instruments Div.
Orthopedic · 44d
Cleared Jan 05, 2012
DIGITAL X-RAY IMAGING SYSTEM
K111103 · MUH
Rf Co., Ltd.
Radiology · 260d
Cleared Jan 05, 2012
ELECTRO-GEL
K111717 · GYB
Electro-Cap Intl., Inc.
Neurology · 199d
Cleared Jan 05, 2012
VALET MICRO CATHETER
K112035 · DQY
Volcano Corporation
Cardiovascular · 174d
Cleared Jan 05, 2012
HALO60 ABLATION CATHETER
K112454 · GEI
Barrx Medical, Inc.
General & Plastic Surgery · 133d
Cleared Jan 05, 2012
PROSPERA PRO-I, PRO-II AND PRO-III NEGATIVE PRESSURE WOUND THERAPY SYSTEM
K112458 · OMP
Medica-Rents Co., Ltd.
General & Plastic Surgery · 132d
Cleared Jan 05, 2012
STRYKER UNIVERSAL NEURO 3 SYSTEM
K112557 · GWO
Stryker
Neurology · 125d
Cleared Jan 05, 2012
NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM
K112955 · KHP
Nova Biomedical Corporation
Chemistry · 93d
Cleared Jan 05, 2012
PROMOS MODULAR SHOULDER SYSTEM
K113012 · KWS
Smith & Nephew, Inc.
Orthopedic · 86d
Cleared Jan 05, 2012
SMITH & NEPHEW INC. UNICOMPARTMENTAL AND BIOCOMPARTMENTAL KNEE SYSTEM...
K113038 · HSX
Smith & Nephew, Inc.
Orthopedic · 85d
Cleared Jan 05, 2012
APEX ARC HIP STEM
K113242 · LPH
Omni Life Science, Inc.
Orthopedic · 64d
Cleared Jan 05, 2012
NMI 2.8 MICROCATHETER
K113638 · DQO
Navilyst Medical, Inc.
Cardiovascular · 27d
Cleared Jan 05, 2012
ORTHOSCAN MOBILE DI MINI C-ARM
K113708 · OXO
Orthoscan, Inc.
Radiology · 20d
Cleared Jan 04, 2012
DYNA LOCKING CANNULATED SCREW
K112240 · HWC
U&I Corp.
Orthopedic · 153d
Cleared Jan 04, 2012
FOCUS MIS SYSTEM
K112643 · NKB
L & K Biomed Co., Ltd.
Orthopedic · 114d
Cleared Jan 04, 2012
NORMATEC MVP
K112890 · IRP
NormaTec Industries, LP
Physical Medicine · 96d
Cleared Jan 04, 2012
DNE EXTERNAL FIXATION SYSTEM
K113106 · KTT
Dne, LLC
Orthopedic · 76d
Cleared Jan 04, 2012
AVIVO MOBILE PATIENT MANAGEMENT
K113187 · MHX
Corventis, Inc.
Cardiovascular · 65d
Cleared Jan 04, 2012
HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL
K113211 · GGN
Instrumentation Laboratory CO
Hematology · 65d
Cleared Jan 04, 2012
CERTUS 140 2.45GHZ ABLATION SYSTEM
K113237 · NEY
Neuwave Medical, Inc.
General & Plastic Surgery · 63d