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

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176,076 results
62857–62880 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 10, 2006
PROFEMUR TL HIP STEM
K060358 · KWA
Wrightmedicaltechnologyinc
Orthopedic · 86d
Cleared May 10, 2006
NEXA CARPO METACARPAL IMPLANT
K060386 · KYI
Nexa Orthopedics, Inc.
Orthopedic · 85d
Cleared May 10, 2006
SYSMEX AUTOMATED HEMATOLOGY ANALYZER MODELS XS SERIES
K060656 · GKZ
Sysmex America, Inc.
Hematology · 58d
Cleared May 10, 2006
XPAND RADIOLUCENT CORPECTOMY SPACER
K060665 · MQP
Globus Medical, Inc.
Orthopedic · 57d
Cleared May 10, 2006
CEMENT-IT ALL PURPOSE, MODEL N97
K060698 · EMA
Pentron Clinical Technologies
Dental · 55d
Cleared May 10, 2006
SYNVITRO CUMULASE (HYALURONIDASE MEDIUM)
K060699 · MQL
Medicult A/S
Obstetrics & Gynecology · 55d
Cleared May 10, 2006
IF TRUE SINE INTERFERENTIAL STIMULATOR / MODEL WL-2206A1 & WI-2206A2
K060975 · LIH
Theratech, Inc.
Neurology · 30d
Cleared May 10, 2006
EVOLUTION MECHANICAL DILATOR SHEATH SET MODELS-LR-EVN-7.0, LR-EVN-9.0
K061000 · DRE
Cook Vascular, Inc.
Cardiovascular · 29d
Cleared May 10, 2006
ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP
K061014 · JPA
Helena Laboratories
Hematology · 27d
Cleared May 10, 2006
DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE,...
K061020 · CKA
Dade Behring, Inc.
Chemistry · 27d
Cleared May 10, 2006
ROBERTSITE STOPCOCK
K061143 · FMG
Halkey-Roberts Corp.
General Hospital · 15d
Cleared May 10, 2006
RHYTHMLINK DISC ELECTRODES
K061148 · GXY
Rhythmlink International, LLC
Neurology · 15d
Cleared May 10, 2006
MUCHECK V7.0
K061152 · LHN
Oncology Data Systems, Inc.
Radiology · 14d
Cleared May 09, 2006
ALPHASPHERE ORBITAL IMPLANT
K053298 · HPZ
Hydron Pty Limited
Ophthalmic · 165d
Cleared May 09, 2006
MICROMANIPULATION MEDIA SYSTEM, LG HYALURONIDASE AND LG PARAFFIN OIL
K053551 · MQL
Intl., Inc.
Obstetrics & Gynecology · 140d
Cleared May 09, 2006
15.5FR DECATHLON COATED TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH...
K060155 · MSD
Spire Biomedical, Inc.
Gastroenterology & Urology · 109d
Cleared May 09, 2006
ACON AUTOMATIC BLOOD PRESSURE MONITOR KIT, MODEL OB11-111, W/AC ADAPTER,...
K060925 · DXN
ACON Laboratories, Inc.
Cardiovascular · 35d
Cleared May 09, 2006
SOLACE POST-OPERATIVE PAIN RELIEF INFUSION SYSTEM
K060933 · MEB
Apex Medical Technologies, Inc.
General Hospital · 34d
Cleared May 09, 2006
PLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPONS
K060981 · HIL
Playtex Products, Inc.
Obstetrics & Gynecology · 29d
Cleared May 09, 2006
BIOBLANKET SURGICAL MESH
K061030 · FTM
Kensey Nash Corporation
General & Plastic Surgery · 25d
Cleared May 09, 2006
AXIOM ARISTOS FX PLUS
K061054 · MQB
Siemens Medical Solutions USA, Inc.
Radiology · 22d
Cleared May 09, 2006
ACCUREX
K061126 · LLZ
Cybermed, Inc.
Radiology · 15d
Cleared May 08, 2006
GIVEN DIAGNOSTIC SYSTEM
K053639 · NEZ
Given Imaging , Ltd.
Gastroenterology & Urology · 129d
Cleared May 08, 2006
ARCADIA MEDICAL SILICONE WIRE REINFORCED ENDOTRACHEAL TUBES
K060094 · BTR
Arcadia Medical Corporation
Anesthesiology · 116d