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
162049–162072 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 05, 1982
OMS QUARTZ INFUSION CONTACT LENS
K820223 · HJI
Optical Micro Systems, Inc.
Ophthalmic · 9d
Cleared Feb 04, 1982
CAPILLARY PERFUSION MONITOR #LD5000
K812005 · DPW
Nuclear Pacific, Inc.
Cardiovascular · 205d
Cleared Feb 04, 1982
PERMANENT ENDOCARD. UNIPOLAR TINED LEAD
K812905 · DTB
Diag Corp.
Cardiovascular · 108d
Cleared Feb 04, 1982
ULTRACAST WATERLESS SYNTHETIC RESIN CAST
K813052 · ITG
Zimmer, Inc.
Physical Medicine · 98d
Cleared Feb 04, 1982
JET VENTILATOR
K813254 · CBK
Healthdyne, Inc.
Anesthesiology · 77d
Cleared Feb 04, 1982
MULTIPLE BANDAGE OR DRESSING
K813365 · FRO
Cederroth, Inc. USA
General & Plastic Surgery · 66d
Cleared Feb 04, 1982
HEMATOLOGY CALIBRATOR S-CAL
K813375 · KSA
Coulter Electronics, Inc.
Hematology · 65d
Cleared Feb 04, 1982
ULTRASONIC FRAGMENTOR
K813389 · HQE
Fibra Sonics, Inc.
Radiology · 63d
Cleared Feb 04, 1982
XOMED MICRO-IRRIGATOR
K813475 · FQH
Xomed, Inc.
General Hospital · 65d
Cleared Feb 04, 1982
OMS INFUSION-ASPIRATION HANDLE
K813500 · HQE
Optical Micro Systems, Inc.
Ophthalmic · 52d
Cleared Feb 04, 1982
XEROFORM DRESSING
K813535 · FRO
W.G. Whitney Corp.
General & Plastic Surgery · 49d
Cleared Feb 04, 1982
CTF MODEL 9300
K813588 · IZI
Thomson-Csf Broadcast, Inc.
Radiology · 38d
Cleared Feb 04, 1982
RAPID E
K813609 · JSS
Dms Laboratories
Microbiology · 37d
Cleared Feb 04, 1982
RAPID STREP
K813610 · JTO
Dms Laboratories
Microbiology · 37d
Cleared Feb 04, 1982
CHE
K813611 · JSC
Dms Laboratories
Microbiology · 37d
Cleared Feb 04, 1982
STAPH TRAC
K813614 · JWX
Dms Laboratories
Microbiology · 37d
Cleared Feb 04, 1982
CHL
K813615 · JSC
Dms Laboratories
Microbiology · 37d
Cleared Feb 04, 1982
STOLTRONICS-LRS
K813637 · KCW
Stoltronic Systems, Inc.
General & Plastic Surgery · 36d
Cleared Feb 04, 1982
PLEUROFIX THORACENTESIS KIT
K820004 · GAZ
Burron Medical Products, Inc.
General Hospital · 31d
Cleared Feb 04, 1982
COMFEEL PROTECTIVE SHEET
K820018 · KGX
Telecam Medical Devices
General & Plastic Surgery · 30d
Cleared Feb 04, 1982
MODIFIED EA 50
K820027 · HZJ
Surgipath
Pathology · 30d
Cleared Feb 04, 1982
CADWELL 5200
K820031 · JXE
Cadwell Laboratories, Inc.
Neurology · 29d
Cleared Feb 04, 1982
SICKLE-CHECK
K820037 · JCM
Diagnostic Technology, Inc.
Hematology · 28d
Cleared Feb 04, 1982
FSH RADIOIMMUNOASSAY TEST SYSTEM
K820048 · CGJ
Monobind
Chemistry · 27d