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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
62785–62808 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 17, 2006
SINCLAIR ORAL RINSE
K053166 · NTO
Sinclair Pharmaceuticals Limited
Dental · 184d
Cleared May 17, 2006
COLUMBUS ULTRA CONGRUENT (UC) TIBIAL INSERT/GLIDING SURFACE
K053579 · JWH
Aesculap, Inc.
Orthopedic · 146d
Cleared May 17, 2006
PORT-A-CATH, PORT-A-CATH II, PROPORT AND P.A.S. PORT IMPLANTABLE VENOUS...
K060036 · LJT
Smiths Medical MD, Inc.
General Hospital · 132d
Cleared May 17, 2006
TAP II ANTI-SNORING AND OBSTRUCTIVE SLEEP APNEA ORAL APPLIANCE WITH ATTACHMENT
K060388 · LRK
Airway Management, Inc.
Dental · 92d
Cleared May 17, 2006
HEMOHALT HEMOSTASIS PAD
K060409 · QSY
Vanson-Halosource, Inc.
General & Plastic Surgery · 90d
Cleared May 17, 2006
ACTIVE UNICOMPARTMENTAL KNEE SYSTEM
K060412 · HRY
Australian Surgical Design & Manufacture
Orthopedic · 90d
Cleared May 17, 2006
TTC PLATE
K060473 · HRS
New Deal, S.A.
Orthopedic · 83d
Cleared May 17, 2006
LAPIDUS PLATE
K060476 · HRS
New Deal, S.A.
Orthopedic · 83d
Cleared May 17, 2006
POWDER FREE NITRILE EXAMINATION GLOVE (BLACK AND GRAY)
K060724 · LZA
Smart Glove Corp. Sdn Bhd
General Hospital · 61d
Cleared May 17, 2006
DEKNA-LOK MODEL BP1000V2L
K060801 · GAM
Teleflex Medical
General & Plastic Surgery · 54d
Cleared May 17, 2006
COSMATRIX
K060829 · FTM
Tei Biosciences, Inc.
General & Plastic Surgery · 51d
Cleared May 17, 2006
ZIMMER DENTAL ONE PIECE TAPERED ABUTMENT, MODELS TAC1, TACW1, TA5C1
K060880 · NHA
Zimmer Dental, Inc.
Dental · 47d
Cleared May 17, 2006
XENFORM SOFT TISSUE REPAIR MATRIX
K060984 · FTM
Tei Biosciences, Inc.
General & Plastic Surgery · 37d
Cleared May 17, 2006
COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM
K061048 · CFR
Roche Diagnostics Corp.
Chemistry · 30d
Cleared May 17, 2006
COULTER LIN-C LINEARITY CONTROL, MODELS 7547065, 723503
K061064 · JPK
Beckman Coulter, Inc.
Hematology · 30d
Cleared May 17, 2006
HAEMONETICS 40U RBC FILTER BAG
K061103 · CAK
Haemonetics Corp.
General Hospital · 27d
Cleared May 16, 2006
MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS
K053230 · CAW
Merits Health Products Co., Ltd.
Anesthesiology · 179d
Cleared May 16, 2006
ABSOANCHOR MICROIMPLANT
K060126 · DZE
Dentos, Inc.
Dental · 118d
Cleared May 16, 2006
POWDER-FREE LATEX PATIENT EXAMINATION GLOVE,WITH EXTRACTABLE PROTEIN CONTENT...
K060775 · LYY
Kossan Latex Industries(M)Sdn Bhd
General Hospital · 55d
Cleared May 16, 2006
SUSCEPTIBILITY TEST PLATE FOR VANCOMYCIN VRSA LIMITATION REMOVAL
K060783 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 55d
Cleared May 16, 2006
MIM 4.0 (NEURO
K060816 · LLZ
Mimvista Corp.
Radiology · 50d
Cleared May 16, 2006
TEMPORARY CROWN & BRIDGE RESIN
K060881 · EBG
Cosmedent, Inc.
Dental · 46d
Cleared May 16, 2006
TINNITUS PHASE-OUT
K061111 · KLW
Tinnitus Control, Inc.
Ear, Nose, Throat · 25d
Cleared May 16, 2006
PROVIDE TEMPORARY CYLINDER
K061177 · NHA
Implant Innovations, Inc.
Dental · 19d