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
52945–52968 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 26, 2009
LIFE SPINE FACET SCREW SPINAL SYSTEM
K090865 · MRW
Life Spine
Orthopedic · 88d
Cleared Jun 26, 2009
PROXIMAL TIBIA LOCKING PLATE STANDARD AND LARGE, 3.5MM LOW PROFILE AND...
K090877 · HRS
DePuy Orthopaedics, Inc.
Orthopedic · 87d
Cleared Jun 26, 2009
ORTHOLOC ANKLE PLATING SYSTEM (APS)
K091243 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 59d
Cleared Jun 26, 2009
WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM, MODELS M00516700, M00516710,...
K091510 · ESW
Boston Scientific Corporation
Gastroenterology & Urology · 35d
Cleared Jun 25, 2009
E. COLI PNA FISH
K082068 · JSS
Advandx, Inc.
Microbiology · 338d
Cleared Jun 25, 2009
CHARTIS CONSOLE
K083199 · BZG
Pulmonx, Inc.
Anesthesiology · 238d
Cleared Jun 25, 2009
ENDOVIVE LOW PROFILE REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX, 8283, 8284, 8285
K083685 · KNT
Mri Manufacturing and Research, Inc.
Gastroenterology & Urology · 195d
Cleared Jun 25, 2009
CHARTIS CATHETER
K083883 · CBI
Pulmonx, Inc.
Anesthesiology · 178d
Cleared Jun 25, 2009
MODIFICATION TO LDR SPINE ROI INTERBODY FUSION SYSTEM
K090507 · MAX
Ldr Spine USA
Orthopedic · 120d
Cleared Jun 25, 2009
VENTLAB 5000 SERIES NEBULIZER ASSEMBLY, CUP, CUP W/ MASK, CUP W/ FITSALL CONN.
K090840 · CAF
Ventlab Corp.
Anesthesiology · 90d
Cleared Jun 25, 2009
COLLAWOUND WOUND DRESSING
K090894 · KGN
Collamatrix Co., Inc.
General & Plastic Surgery · 86d
Cleared Jun 25, 2009
VERICORE ABUTMENT IN ZIRCONIA FOR IMPLANT SYSTEMS
K090976 · NHA
Whip-Mix Corp.
Dental · 80d
Cleared Jun 25, 2009
VALIDATE GC1, GC2, GC3 AND GC4 CALIBRATION VERIFICATION/LINEARITY TEST SET
K091225 · JJY
Maine Standards Co.
Chemistry · 59d
Cleared Jun 25, 2009
LUMBOFIX CONDUCTIVE GARMENT, MODEL 420 BACK
K091317 · GZJ
Bio-Medical Research, Ltd.
Neurology · 52d
Cleared Jun 25, 2009
XTAG RESPIRATORY VIRAL PANEL, MODELS I019A0110, I019C011, I019D0112,...
K091667 · OCC
Luminex Molecular Diagnostics, Inc.
Microbiology · 16d
Cleared Jun 24, 2009
BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD
K090109 · CGA
Epocal, Inc.
Chemistry · 160d
Cleared Jun 24, 2009
TRULY INFRARED EAR THERMOMETER, MODEL TET-350, TET-360, TET-370
K090564 · FLL
Truly Instrument Limited
General Hospital · 114d
Cleared Jun 24, 2009
TDS ABUTMENT FOR NOBEL BIOCARE REPLACE
K091026 · NHA
Pou YU Biotechnology Co., Ltd.
Dental · 75d
Cleared Jun 24, 2009
FULL BREATH SLEEP APPLIANCE LOWER (FBSL)
K091035 · LQZ
Bryan Keropian Dds
Dental · 75d
Cleared Jun 24, 2009
XIA 3 SPINAL SYSTEM, UNIPLANNER/REDUCTION SCREWS & VITALLIUM ROD
K091291 · NKB
Stryker Spine
Orthopedic · 54d
Cleared Jun 24, 2009
NORAS OR HEAD COIL 3T, MODELS SI7200/SI72100/SI7220/SI7230
K091546 · MOS
Noras Mri Products GmbH
Radiology · 28d
Cleared Jun 24, 2009
GE LIGHTSPEED ACT FP16
K091673 · JAK
Ge Medical Systems, Inc.
Radiology · 15d
Cleared Jun 23, 2009
INTELEPACS, MODEL VERSION 3.X.X
K083520 · LLZ
Intelerad Medical Systems Incorporated
Radiology · 209d
Cleared Jun 23, 2009
FEMVUE(TM) CATHETER SYSTEM
K083690 · LKF
Femasys, Inc.
Obstetrics & Gynecology · 193d