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
47569–47592 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 04, 2011
GENOSS COLLAGEN MEMBRANE MODEL GCM1020, GCM3040 TOTAL 6 MODELS
K102307 · NPL
Genoss Co., Ltd.
Dental · 261d
Cleared May 04, 2011
ENDOFUSE INTRA-OSSEOUS FUSION SYSTEM
K102324 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 260d
Cleared May 04, 2011
ADVIA CENTAUR TOXOPLASMA IGG (TOXO G)
K102681 · LGD
Siemens Healthcare Diagnostics, Inc.
Microbiology · 229d
Cleared May 04, 2011
HARDYCHROM MRSA
K102922 · JSO
Hardy Diagnostics
Microbiology · 215d
Cleared May 04, 2011
AFFYMETRIX GENE PROFILING REAGENTS
K103112 · OVA
Affymetrix, Inc.
Immunology · 195d
Cleared CT May 04, 2011
REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529 AND REVEAL DX INSERTABLE...
K103764 · DSI
Medtronic, Inc.
Cardiovascular · 132d
Cleared May 04, 2011
SENSILASE PAD-IQ
K110438 · DPW
Vasamed, Inc.
Cardiovascular · 78d
Cleared May 04, 2011
QUICK UP
K110440 · EBI
Voco GmbH
Dental · 78d
Cleared May 03, 2011
MAC MALE ADAPTER
K102843 · KTT
Biomet Trauma (Aka Ebi, LLC)
Orthopedic · 216d
Cleared May 03, 2011
BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM
K110039 · JDQ
Biomet Sports Medicine
Orthopedic · 117d
Cleared May 03, 2011
CORIN TRINITY ACETBULAR SYSTEM WITH HXLPE LINERS
K110087 · LZO
Corin USA
Orthopedic · 111d
Cleared May 03, 2011
CLEAR+BRILLIANT LASER SYSTEM
K110349 · ONG
Solta Medical, Inc.
General & Plastic Surgery · 85d
Cleared May 03, 2011
DILON 6800 ACELLA (ACELLA)
K110384 · IYX
Dilon Technologies, Inc.
Radiology · 82d
Cleared May 03, 2011
ROCHE ORAL FLUID AMPHETAMINE, ROCHE ORAL FLUID DAT QUAL CAL B, ROCHE ORAL...
K110446 · DKZ
Roche Diagnostics
Toxicology · 76d
Cleared May 03, 2011
READY VIEW
K110573 · LLZ
Ge Healthcare (Ge Medical Systems Scs)
Radiology · 63d
Cleared May 03, 2011
PREMIER C. DIFFICILE GDH
K110620 · MCB
Meridian Bioscience, Inc.
Microbiology · 61d
Cleared May 03, 2011
TINNITUS SOUND GENERATOR MODULE
K110932 · KLW
Gn Resound A/S
Ear, Nose, Throat · 29d
Cleared May 03, 2011
ORIGEN DBM WITH BIOACTIVE GLASS, NANOFUSE DBM
K110976 · MQV
Nanotherapeutics, Inc.
Orthopedic · 26d
Cleared May 03, 2011
ICON ADULT MANUAL
K110985 · IOR
Icon Wheelchairs, Inc.
Physical Medicine · 25d
Cleared May 03, 2011
PICCOLO COMPOSITE NAILING SYSTEM
K111056 · HSB
CarboFix Orthopedics , Ltd.
Orthopedic · 15d
Cleared May 02, 2011
WEBSTER DUO-DECAPOLAR CATHETER
K101991 · DRF
Biosense Webster, Inc.
Cardiovascular · 292d
Cleared May 02, 2011
TRANSTEK GLASS BODY ANALYZER
K102191 · MNW
Zhongshan Transtek Electronics Co., Ltd.
Gastroenterology & Urology · 272d
Cleared May 02, 2011
DURAFIBER AG
K103793 · FRO
Smith & Nephew, Inc.
General & Plastic Surgery · 126d
Cleared Apr 29, 2011
DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRA
K093640 · IXK
Electron Jsco.
Radiology · 521d